{"id":"genotropin","rwe":[{"pmid":"41837704","year":"2026","title":"Once-Weekly Somatrogon in Pediatric Growth Hormone Deficiency: Real-World Efficacy, Safety, and Quality-of-Life Findings.","finding":"","journal":"Journal of clinical research in pediatric endocrinology","studyType":"Clinical Study"},{"pmid":"41758754","year":"2026","title":"Once-weekly Lonapegsomatropin was Efficacious and Well Tolerated in Chinese Children with Growth Hormone Deficiency: Results from a Phase 3 Randomized Trial.","finding":"","journal":"Hormone research in paediatrics","studyType":"Clinical Study"},{"pmid":"41638751","year":"2026","title":"Recombinant human growth hormone (rHGH) for muscle enhancement in knee osteoarthritis: protocol for a pilot, randomised placebo-controlled trial.","finding":"","journal":"BMJ open","studyType":"Clinical Study"},{"pmid":"41626296","year":"2026","title":"PPP1R12A Mutation Presenting With Congenital Jejunal Atresia and Short Stature: A Pediatric Endocrinology Case Report.","finding":"","journal":"Case reports in pediatrics","studyType":"Clinical Study"},{"pmid":"41516871","year":"2025","title":"Evaluation of Somatropin Release from Chitosan and Methylcellulose Hydrogels: Influence of Hydrogel Composition and Phosvitin on the Release Profile.","finding":"","journal":"Polymers","studyType":"Clinical Study"}],"_fda":{"id":"b67c2419-4feb-4ce1-b97e-88760a8e1aee","set_id":"1058e17c-9261-459c-a3e6-fae38d196c14","openfda":{"nui":["N0000175606","M0028842"],"unii":["NQX9KB6PCL"],"route":["SUBCUTANEOUS"],"rxcui":["847243","847245","847247","847348","849850","849851","1736262","1736329"],"spl_id":["b67c2419-4feb-4ce1-b97e-88760a8e1aee"],"brand_name":["Norditropin"],"spl_set_id":["1058e17c-9261-459c-a3e6-fae38d196c14"],"package_ndc":["0169-7704-21","0169-7704-92","0169-7705-21","0169-7705-92","0169-7708-21","0169-7708-92","0169-7703-11","0169-7703-91","0169-7703-21","0169-7703-92"],"product_ndc":["0169-7703","0169-7704","0169-7705","0169-7708"],"generic_name":["SOMATROPIN"],"product_type":["HUMAN PRESCRIPTION DRUG"],"pharm_class_cs":["Human Growth Hormone [CS]"],"substance_name":["SOMATROPIN"],"pharm_class_epc":["Recombinant Human Growth Hormone [EPC]"],"manufacturer_name":["Novo Nordisk"],"application_number":["BLA021148"],"is_original_packager":[true]},"version":"30","pregnancy":["8.1 Pregnancy Risk Summary Limited available data with somatropin use in pregnant women are insufficient to determine a drug-associated risk of adverse developmental outcomes. In animal reproduction studies, there was no evidence of fetal or neonatal harm when pregnant rats were administered subcutaneous NORDITROPIN during organogenesis or during lactation at doses approximately 10-times higher than the maximal clinical dose of 0.016 mg/kg, based on body surface area (see Data). The estimated background risk of birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In an embryo-fetal development study, NORDITROPIN was administered via subcutaneous injection to pregnant rats from gestation Day 6 to 17, corresponding with the period of organogenesis. NORDITROPIN did not adversely affect fetal viability or developmental outcomes at maternal doses that were approximately 10-times the clinical dose of 0.016 mg/kg, based on body surface area. In a pre- and post-natal development study in pregnant rats, NORDITROPIN was administered from gestation Day 17 through lactation Day 21 (weaning). No adverse developmental effects were observed in the offspring at doses up to 1.1 mg/kg (approximately 10 times the clinical dose of 0.016 mg/kg, based on body surface area)."],"overdosage":["10 OVERDOSAGE Short-term overdosage could lead initially to hypoglycemia and subsequently to hyperglycemia. Overdose with somatropin is likely to cause fluid retention. Long-term overdosage could result in signs and symptoms of gigantism and/or acromegaly consistent with the known effects of excess growth hormone ."],"description":["11 DESCRIPTION Somatropin is a human growth hormone (GH) produced by recombinant DNA technology using Escherichia Coli. The protein is comprised of 191 amino acids and has a molecular weight of about 22,000 daltons. The amino acid sequence is identical to that of human growth hormone of pituitary origin. NORDITROPIN (somatropin) injection is a sterile, clear and colorless solution for subcutaneous use in ready-to-administer prefilled single-patient-use pens with a volume of 1.5 mL or 3 mL with a pH of 6.13–6.20. Each NORDITROPIN contains the following (see Table 3 ): Table 3. Contents of NORDITROPIN Pen Component 5 mg/1.5 mL 10 mg/1.5 mL 15 mg/1.5 mL 30 mg/3 mL Somatropin 5 mg 10 mg 15 mg 30 mg Histidine 1 mg 1 mg 1.7 mg 3.3 mg Mannitol 60 mg 60 mg 58 mg 117 mg Phenol 4.5 mg 4.5 mg 4.5 mg 9 mg Poloxamer 188 4.5 mg 4.5 mg 4.5 mg 9 mg Hydrochloric acid/sodium hydroxide to adjust pH as needed as needed as needed as needed Water for Injection, USP up to 1.5 mL up to 1.5 mL up to 1.5 mL up to 3 mL"],"how_supplied":["16 HOW SUPPLIED/STORAGE AND HANDLING NORDITROPIN (somatropin) injection is a clear and colorless solution available as FlexPro single-patient-use prefilled pens: • NORDITROPIN FlexPro 5 mg/1.5 mL (orange) NDC 0169-7704-21 • NORDITROPIN FlexPro 10 mg/1.5 mL (blue) NDC 0169-7705-21 • NORDITROPIN FlexPro 15 mg/1.5 mL (green) NDC 0169-7708-21 • NORDITROPIN FlexPro 30 mg/3 mL (purple) NDC 0169-7703-21 NORDITROPIN 5 mg/1.5 mL, 10 mg/1.5 mL, and 15 mg/1.5 mL FlexPro pens are compatible with FlexPro PenMate. The FlexPro PenMate is an accessory device that is dispensed separately with its enclosed Instructions for Use. NORDITROPIN 30 mg/3 mL FlexPro pen is not compatible with FlexPro PenMate. Each NORDITROPIN FlexPro pen is for use by a single patient. A NORDITROPIN FlexPro pen must never be shared between patients, even if the needle is changed. Unused NORDITROPIN FlexPro prefilled pens must be stored refrigerated at 2°C to 8°C (36°F to 46°F). Do not store directly adjacent to the refrigerator cooling element. Do not freeze. Avoid direct light. Table 14 – Storage Conditions and Expiration Before Use In-use (After 1 st injection) Storage requirement Storage Option 1 (Refrigeration) Storage Option 2 (Room temperature) 2ºC to 8ºC (36ºF to 46ºF) Until exp. date 2ºC to 8ºC (36ºF to 46ºF) 4 weeks Up to 25ºC (77ºF) 3 weeks"],"geriatric_use":["8.5 Geriatric Use The safety and effectiveness of NORDITROPIN in patients aged 65 and over has not been evaluated in clinical studies. Elderly patients may be more sensitive to the action of somatropin, and therefore may be more prone to develop adverse reactions. A lower starting dose and smaller dose increments should be considered for older patients [see Dosage and Administration (2.3) ]."],"pediatric_use":["8.4 Pediatric Use Safety and effectiveness of NORDITROPIN in pediatric patients have been established in growth failure due to inadequate secretion of endogenous growth hormone, short stature associated with Noonan syndrome, short stature associated with Turner syndrome, short stature in children born small for gestational age (SGA) with no catch-up growth by age 2 years to 4 years of age, idiopathic short stature (ISS), and growth failure due to Prader-Willi syndrome (PWS). Growth Failure due to Inadequate Secretion of Endogenous Growth Hormone Safety and effectiveness of NORDITROPIN have been established in pediatric patients with growth failure due to growth hormone deficiency in a multi-center, prospective, randomized, open-label, dose-response study in 111 pediatric patients conducted for a two-year period [see Clinical Studies (14.1) ]. Short Stature Associated with Noonan Syndrome Safety and effectiveness of NORDITROPIN have been established in pediatric patients with Noonan syndrome in a prospective, open-label, randomized, parallel group study in 21 pediatric patients conducted for 2 years [see Clinical Studies (14.2) ]. Short Stature Associated with Turner Syndrome Safety and effectiveness of NORDITROPIN have been established in pediatric patients with short stature associated with Turner syndrome in two randomized, parallel group, open-label, multicenter studies in 87 pediatric patients [see Clinical Studies (14.3) ]. Short Stature in Pediatric Patients Born Small for Gestational Age (SGA) with No Catch-up Growth by Age 2 Years to 4 Years of Age Safety and effectiveness of NORDITROPIN have been established in pediatric patients with short stature born SGA with no catch-up growth in a multi-center, randomized, double-blind, two-arm study to final height in 53 pediatric patients and in a randomized study of 84 prepubertal, non-GHD, Japanese pediatric patients [see Clinical Studies (14.4) ]. Idiopathic Short Stature (ISS) Safety and effectiveness of NORDITROPIN have been established in pediatric patients with ISS based on data from a randomized, open-label clinical study with another somatropin product in 105 pediatric patients [see Clinical Studies (14.5) ]. Growth Failure Due to Prader-Willi Syndrome (PWS) Safety and effectiveness of NORDITROPIN have been established in pediatric patients with growth failure due to Prader-Willi Syndrome based on data from two randomized, open label, controlled clinical trials with another somatropin product in pediatric patients. There have been reports of sudden death after initiating therapy with somatropin in pediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection. Male patients with one or more of these factors may be at greater risk than females. Patients with Prader-Willi syndrome should be evaluated for signs of upper airway obstruction and sleep apnea before initiation of treatment with somatropin. [see Contraindications (4) , Warnings and Precautions (5.2) , Clinical Studies (14.6) ]."],"effective_time":"20250707","clinical_studies":["14 CLINICAL STUDIES 14.1 Growth Failure due to Inadequate Secretion of Endogenous Growth Hormone The efficacy and safety of NORDITROPIN was assessed in a multicenter, prospective randomized, open label, dose response study with three doses (0.025, 0.05 and 0.1 mg/kg/day). A total of 111 pediatric patients with GH deficiency were randomized to each dose; 37(0.025 mg/kg/day):38(0.05 mg/kg/day):36(0.1 mg/kg/day). Patients met the following entry criteria: chronological age ≥ 3 years with a skeletal age < 10 years if male and < 8 years if female; pubertal stage = stage 1; previously untreated GH deficiency; peak plasma hormone concentration < 7 ng/ml or < 10 ng/ml (depending on assay used) in two tests. The results are displayed in Table 4 . The adjusted mean increases in HSDS over the 2-year period were 0.81, 1.57 and 1.73 in the 0.025, 0.05 and 0.1 mg/kg/day dose groups, respectively. There was no significant difference in ΔHSDS between the 0.05 and 0.1 mg/kg/day treatment groups. Height velocity (HV, cm/year) and HVSDS increased considerably after initiation of treatment, with the greatest response observed during the first year of treatment. Table 4 – Efficacy of NORDITROPIN in Pediatric GH Deficiency NORDITROPIN 0.025 mg/kg/day 0.05 mg/kg/day 0.1 mg/kg/day N Mean SD N Mean SD N Mean SD Change in Standing Height (cm) Baseline to Month 12 37 9.5 2.1 37 13.2* 2.6 34 13.7* 2.7 Baseline to Month 24 34 17.6 3.4 37 22.2* 4.7 33 23.7* 4.0 Change in Sitting Height (cm) Baseline to Month 12 32 5.4 2.4 36 6.5* 1.6 32 7.4** 1.5 Baseline to Month 24 29 9.3 2.5 35 10.8** 2.6 31 12.2** 2.0 Change in Bone Age (yr) Baseline to Month 12 37 1.3 0.9 38 1.7 0.8 34 1.6 0.8 Month 12 to Month 24 37 0.6 2.5 38 1.4 2.7 34 1.6* 0.8 *Significant (p <0.05) change from baseline compared to the 0.025 mg/kg/group **Significant (p <0.05) change from baseline compared to both other groups 14.2 Short Stature Associated with Noonan Syndrome A prospective, open label, randomized, parallel group study with 21 pediatric patients was conducted for 2 years to evaluate the efficacy and safety of NORDITROPIN. Additional 6 children were not randomized, but did follow the protocol. Inclusion criteria included bone age determination showing no significant acceleration, prepubertal status, height SDS <-2, and HV SDS <1 during the 12 months pre-treatment. Exclusion criteria were previous or ongoing treatment with growth hormone, anabolic steroids or corticosteroids, congenital heart disease or other serious disease perceived to possibly have major impact on growth, FPG >6.7 mmol/L (>120 mg/dL), or growth hormone deficiency (peak GH levels <10 ng/mL). The twenty-four, 12 female and 12 male, patients 3 – 14 years of age received either 0.033 mg/kg/day or 0.066 mg/kg/day of NORDITROPIN subcutaneously which was adjusted based on growth response after the first 2 years. After the initial two-year study, NORDITROPIN treatment continued until final height. Retrospective final height was collected from 18 patients in the study and the 6 who had followed the protocol without randomization. Historical reference materials of height velocity and adult height analyses of Noonan patients served as the controls. Patients obtained a final height (FH) gain from baseline of 1.5 and 1.6 SDS estimated according to the national and the Noonan reference, respectively. A height gain of 1.5 SDS (national) corresponds to a mean height gain of 9.9 cm in boys and 9.1 cm in girls at 18 years of age, while a height gain of 1.6 SDS (Noonan) corresponds to a mean height gain of 11.5 cm in boys and 11.0 cm in girls at 18 years of age. A comparison of HV between the two treatment groups during the first two years of treatment for the randomized subjects was 10.1 and 7.6 cm/year with 0.066 mg/kg/day versus 8.55 and 6.7 cm/year with 0.033 mg/kg/day, for Year 1 and Year 2, respectively. 14.3 Short Stature Associated with Turner Syndrome Two randomized, parallel group, open label, multicenter studies were conducted in the Netherlands to evaluate the efficacy and safety of NORDITROPIN. Patients were treated to final height in both studies [height velocity (HV) < 2 cm/year]. Changes in height were expressed as standard deviation scores (SDS) utilizing reference data for untreated Turner syndrome patients as well as the national Dutch population. In Study 1, 68 euthyroid Caucasian patients stratified based on age and baseline height SDS were randomized in a 1:1:1 ratio to three different NORDITROPIN treatment regimens: 0.045 mg/kg/day (Dose A) for the entire study; 0.045 mg/kg/day for the first year and 0.067 mg/kg/day thereafter (Dose B); or 0.045 mg/kg/day for the first year, 0.067 for the second year, and 0.089 mg/kg/day thereafter (Dose C). At baseline, mean age was 6.5 years, mean height SDS (National standard) was -2.7, and mean HV during the previous year was 6.5 cm/year. Patients also received estrogen therapy after age 12 and following four years of NORDITROPIN treatment if they did not have spontaneous puberty. Patients were treated for a mean of 8.4 years. As seen in Table 5 , overall mean final height was 161 cm in the 46 children who attained final height. Seventy percent of these children reached a final height within the normal range (height SDS > -2 using the National standard). A greater percentage of children in the two escalated dose groups reached normal final height. The mean changes from baseline to final height in height SDS after treatment with Dose B and Dose C were significantly greater than the mean changes observed after treatment with Dose A (utilizing both the National and Turner standards). The mean changes from baseline to final height in height SDS (Turner standard) in Table 5 correspond to mean height gains of 9.4, 14.1 and 14.4 cm after treatment with Doses A, B and C, respectively. The mean changes from baseline to final height in height SDS (National standard) in Table 5 correspond to mean height gains of 4.5, 9.1 and 9.4 cm after treatment with Doses A, B and C, respectively. In each treatment group, peak HV was observed during treatment Year 1, and then gradually decreased each year; during Year 4, HV was less than the pre-treatment HV. However, between Year 2 and Year 6, a greater HV was observed in the two dose escalation groups compared to the 0.045 mg/kg/day group. Table 5 – Final Height-Related Results After Treatment of Patients with Turner Syndrome with NORDITROPIN in a Randomized, Dose Escalating Study Dose A 0.045 mg/kg/day (n = 19) Dose B up to 0.067 mg/kg/day (n = 15) Dose C up to 0.089 mg/kg/day (n = 12) Total (n = 46) Baseline height (cm) 1 105 (12) 108 (12.7) 107 (11.7) 106 (11.9) Final height (cm) 1 157 (6.7) 163 (6.0) 163 (4.9) 161 (6.5) Number (%) of patients reaching normal height (height SDS >-2 using National standard) 10 (53%) 12 (80%) 10 (83%) 32 (70%) Height SDS (Turner standard) 2 Final [95% CI] 1.7 [1.4, 2.0] 2.5 [2.1, 2.8] 3 2.5 [2.1, 2.9] 4 NA Change from baseline [95% CI] 1.5 [1.2, 1.8] 2.2 [1.9, 2.5] 3 2.2 [1.9, 2.6] 4 NA Height SDS (National standard) 2 Final [95% CI] -1.9 [-2.2, -1.6] -1.2 [-1.5, -0.9] 4 -1.2 [-1.6, -0.8] 5 NA Change from baseline [95% CI] 0.7 [0.4, 1.0] 1.4 [1.1, 1.7] 4 1.4 [1.1, 1.8] 5 NA Values are expressed as mean (SD) unless otherwise indicated. SDS: Standard deviation score. 1 Unadjusted (raw) means; 2 Adjusted (least squares) means based on an ANCOVA model including terms for treatment, duration of treatment, age at baseline, bone age at baseline, height SDS at baseline, age at onset of puberty and mid-parental target height SDS; 3 p=0.005 vs. Dose A; 4 p=0.006 vs. Dose A; 5 p=0.008 vs. Dose A In Study 2, 19 euthyroid Caucasian patients (with bone age ≤13.9 years) were randomized to treatment with 0.067 mg/kg/day of NORDITROPIN as a single subcutaneous dose in the evening, or divided into two doses (1/3 morning and 2/3 evening). All subjects were treated with concomitant ethinyl estradiol. Overall, at baseline, mean age was 13.6 years, mean height SDS (National standard) was -3.5 and mean HV during the previous year was 4.3 cm/year. Patients were treated for a mean of 3.6 years. In that there were no significant differences between the two treatment groups for any linear growth variables, the data from all patients were pooled. Overall mean final height was 155 cm in the 17 children who attained final height. Height SDS changed significantly from -3.5 at baseline to -2.4 at final height (National standard), and from 0.7 to 1.3 at final height (Turner standard). 14.4 Short Stature in Pediatric Patients Born Small for Gestational Age (SGA) with No Catch-up Growth by Age 2-4 Years A multi-center, randomized, double-blind, two-arm study to final height (Study 1) and a 2-year, multi-center, randomized, double-blind, parallel-group study (Study 2) were conducted to assess the efficacy and safety of NORDITROPIN. Changes in height and height velocity were compared to a national reference population in both studies. Study 1 included 53, 38 male, 15 female, non-GHD, Dutch prepubertal pediatric patients 3-11 years of age with short stature born SGA with no catch-up growth. Catch-up growth was defined as obtaining a height of ≥ 3 rd percentile within the first 2 years of life or at a later stage. Inclusion criteria included: birth length < 3 rd percentile for gestational age, and height velocity (cm/year) for chronological age < 50 th percentile. Exclusion criteria included chromosomal abnormalities, signs of a syndrome (except for Silver-Russell syndrome), serious/chronic co-morbid disease, malignancy, and previous rhGH therapy. NORDITROPIN was administered subcutaneously daily at bedtime at a dose of approximately 0.033 (Dose A) or 0.067 mg/kg/day (Dose B) for the entire treatment period. Final height was defined as a height velocity below 2 cm/year. Treatment with NORDITROPIN was continued to final height for up to 13 years. Mean duration of treatment was 9.5 years (boys) and 7.9 years (girls). 38 out of 53 children (72%) reached final height. Sixty-three percent (24 out of 38) of the children who reached final height were within the normal range of their healthy peers (Dutch national reference). For both doses combined, actual mean final height was 171 (SD 6.1) cm in boys and 159 (SD 4.3) cm in girls. As seen in Table 6 , for boys and girls combined, both mean final height SDS, and increase in height SDS from baseline to final height, were significantly greater after treatment with Dose B (0.067 mg/kg/day). A similar dose response was observed for the increase in height SDS from baseline to Year 2 ( Table 6 ). Overall mean height velocity at baseline was 5.4 cm/y (SD 1.2; n=29). Height velocity was greatest during the first year of NORDITROPIN treatment and was significantly greater after treatment with Dose B (mean 11.1 cm/y [SD 1.9; n=19]) compared with Dose A (mean 9.7 cm/y [SD 1.3; n=10]). Table 6 – Study 1: Results for Final Height SDS and Change from Baseline to Final Height in Height SDS Using National Standard After Long-Term Treatment of SGA Children with NORDITROPIN Raw Mean ± SD (N) Dose A 0.033 mg/kg/day Dose B 0.067 mg/kg/day Total Baseline Height SDS -3.2 ± 0.7 (26) -3.2 ± 0.7 (27) -3.2 ± 0.7 (53) Adjusted least-squares mean ± standard error (N), Treatment Difference [95% confidence intervals] Height SDS: Change from Baseline at Year 2 2 1.4 ± 0.1 (26) 1.8 ± 0.1 (26) Treatment Diff = 0.4 [0.2, 0.7] 3 Height SDS: Change from Baseline at Final Height 1 1.4 ± 0.2 (19) 1.8 ± 0.2 (19) Treatment Diff = 0.5 [0.0, 0.9] 3 Final Height SDS 1 -1.8 ± 0.2 (19) -1.3 ± 0.2 (19) Final Height SDS > -2 13/19 (68%) 11/19 (58%) 24/38 (63%) SDS: Standard deviation score. 1 Adjusted (least-squares) means based on an ANCOVA model including terms for treatment, gender, age at baseline, bone age at baseline, height SDS at baseline, duration of treatment, peak GH after stimulation and baseline IGF-1. 2 Adjusted (least-squares) means based on an ANCOVA model including terms for treatment, gender, age at baseline, height SDS at baseline, and pubertal status. 3 p<0.05 In study 2, 84 randomized, prepubertal, non-GHD, Japanese children (age 3-8) were treated for 2 years with 0.033 or 0.067 mg/kg/day of NORDITROPIN subcutaneously daily at bedtime or received no treatment for 1 year. Additional inclusion criteria included birth length or weight SDS ≤ -2 or < 10 th percentile for gestational age, height SDS for chronological age ≤ -2, and height velocity SDS for chronological age < 0 within one year prior to Visit 1. Exclusion criteria included diabetes mellitus, history or presence of active malignancy, and serious co-morbid conditions. As seen in Table 7 , for boys and girls combined, there was a dose-dependent increase in height SDS at Year 1 and Year 2. The increase in height SDS from baseline to Year 2 (0.033 mg/kg/day, 0.8 vs. 0.067 mg/kg/day, 1.4) was significantly greater after treatment with 0.067 mg/kg/day. In addition, the increase in height SDS at Year 1 was significantly greater in both active treatment groups compared to the untreated control group. Table 7 – Study 2: Results for Change from Baseline in Height SDS At Year 1 and Year 2 Using National Standard After Short-Term Treatment of SGA Children with NORDITROPIN Raw Mean ± SD (N) No Treatment 0.033 mg/kg/day 0.067 mg/kg/day Height SDS: Baseline -2.9 ± 0.5 (15) -3.0 ± 0.6 (35) -2.9 ± 0.7 (34) Height SDS: Year 1 -2.8 ± 0.5 (15) -2.4 ± 0.6 (33) -2.0 ± 0.8 (34) Height SDS: Year 2 NA -2.2 ± 0.7 (33) -1.4 ± 0.7 (32) Adjusted least-squares mean ± standard error (N), Treatment Diff [95% confidence intervals] Height SDS: Change from Baseline at Year 1 1 0.1 ± 0.1 (15) 0.6 ± 0.1 (33) 0.9 ± 0.1 (34) 0.033 vs. No Treatment: Treatment Diff = 0.5, [0.3, 0.7] 2 0.067 vs. No Treatment: Treatment Diff = 0.8, [0.6, 1.0] 2 0.067 vs. 0.033: Treatment Diff = 0.3, [0.2, 0.5] 2 Height SDS: Change from Baseline at Year 2 1 NA 0.8 ± 0.1 (33) 1.4 ± 0.1 (32) 0.067 vs. 0.033: Treatment Diff = 0.6, [0.5, 0.8], p-value < 0.0001 SDS: Standard deviation score. 1 Adjusted (least-squares) means based on an ANCOVA model including terms for treatment, gender, age at baseline, and height SDS at baseline. All children remained prepubertal during the study. 2 p< 0.0001 14.5 Idiopathic Short Stature (ISS) The efficacy and safety of another somatropin product was evaluated in 105 patients who were retrospectively identified as having ISS in a randomized, open-label, clinical study. Patients were enrolled on the basis of short stature, stimulated GH secretion > 10 ng/mL, and prepubertal status. All patients were observed for height progression for 12 months and were subsequently randomized to this other somatropin product or observation only and followed to final height. Two doses of this other somatropin product were evaluated in this trial: 0.23 mg/kg/week (0.033 mg/kg/day) and 0.47 mg/kg/week (0.067 mg/kg/day). Baseline patient characteristics for the ISS patients who remained prepubertal at randomization (n= 105) were: mean (± SD): chronological age 11.4 (1.3) years, height SDS -2.4 (0.4), height velocity SDS -1.1 (0.8), and height velocity 4.4 (0.9) cm/yr, IGF-1 SDS -0.8 (1.4). Patients were treated for a median duration of 5.7 years. Results for final height SDS are displayed by treatment arm in Table 8 . The observed mean gain in final height was 9.8 cm for females and 5.0 cm for males for both doses combined compared to untreated control subjects. A height gain of 1 SDS was observed in 10% of untreated subjects, 50% of subjects receiving 0.23 mg/kg/week and 69% of subjects receiving 0.47 mg/kg/week. Table 8 – Final height SDS results for pre-pubertal patients with ISS* Another Somatropin Product Untreated (n=30) 0.033 mg/kg/day (n=30) 0.067 mg/kg/day (n=42) 0.033 vs Untreated (95% CI) 0.067 vs Untreated (95% CI) Baseline height SDS Final height SDS minus baseline 0.41 (0.58) 0.95 (0.75) 1.36 (0.64) +0.53 (0.20, 0.87)** +0.94 (0.63, 1.26)** Baseline predicted ht Final height SDS minus baseline predicted final height SDS 0.23 (0.66) 0.73 (0.63) 1.05 (0.83) +0.60 (0.09, 1.11)** +0.90 (0.42, 1.39)** Least square means based on ANCOVA (final height SDS and final height SDS minus baseline predicted height SDS were adjusted for baseline height SDS) * Mean (SD) are observed values **p<0.05 14.6 Growth Failure Due to Prader-Willi Syndrome (PWS) The safety and efficacy of another somatropin product were evaluated in two randomized, open-label, controlled clinical studies. Patients received either this other somatropin product or no treatment for the first year of the studies, while all patients received this other somatropin product during the second year. This other somatropin product was administered as a daily SC injection, and the dose was calculated for each patient every 3 months. In Study 1, the treatment group received this other somatropin product at a dose of 0.24 mg/kg/week during the entire study. During the second year, the control group received this other somatropin product at a dose of 0.48 mg/kg/week. In Study 2, the treatment group received this other somatropin product at a dose of 0.36 mg/kg/week during the entire study. During the second year, the control group received this other somatropin product at a dose of 0.36 mg/kg/week. The results are presented in Table 9 . Linear growth continued to increase in the second year, when both groups received treatment with this other somatropin product. Table 9 – Efficacy of Another Somatropin Product in Pediatric Patients with Prader-Willi Syndrome (Mean ± SD) Study 1 Study 2 Another Somatropin Product (0.24 mg/kg/week) (n=15) Untreated Control (n=12) Another Somatropin Product (0.36 mg/kg/week) (n=7) Untreated Control (n=9) Linear growth (cm) Baseline height 112.7 ± 14.9 109.5 ± 12.0 120.3 ± 17.5 120.5 ± 11.2 Growth from 0 to 12 months 11.6* ± 2.3 5.0 ± 1.2 10.7* ± 2.3 4.3 ± 1.5 Baseline SDS -1.6 ± 1.3 -1.8 ± 1.5 -2.6 ± 1.7 -2.1 ± 1.4 SDS at 12 months -0.5* ± 1.3 -1.9 ± 1.4 -1.4* ± 1.5 -2.2 ± 1.4 * p <0.05 14.7 Adults with Growth Hormone Deficiency (GHD) A total of six randomized, double-blind, placebo-controlled studies were performed. Two representative studies, one in adult onset (AO) GHD patients and a second in childhood onset (CO) GHD patients, are described below. Study 1 A single center, randomized, double-blind, placebo-controlled, parallel-group, six month clinical trial was conducted in 31 adults with AO GHD comparing the effects of NORDITROPIN (somatropin) injection and placebo on body composition. Patients in the active treatment arm were treated with NORDITROPIN 0.017 mg/kg/day (not to exceed 1.33 mg/day). The changes from baseline in lean body mass (LBM) and percent total body fat (TBF) were measured by total body potassium (TBP) after 6 months. Treatment with NORDITROPIN produced a significant increase from baseline in LBM compared to placebo ( Table 10 ). Table 10 – Lean Body Mass (kg) by TBP NORDITROPIN (n=15) Placebo (n=16) Baseline (mean) 50.27 51.72 Change from baseline at 6 months (mean) 1.12 -0.63 Treatment difference (mean) 95% confidence interval p-value 1.74 (0.65, 2.83) p=0.0028* *Least square mean based on an ANOVA model including treatment and sex as factors Analysis of the treatment difference on the change from baseline in percent TBF revealed a significant decrease in the NORDITROPIN-treated group compared to the placebo group ( Table 11 ). Table 11 – Total Body Fat (%) by TBP NORDITROPIN (n=15) Placebo (n=16) Baseline (mean) 44.74 42.26 Change from baseline at 6 months (mean) -2.83 1.92 Treatment difference (mean) 95% confidence interval p-value -4.74 (-7.18, -2.30) p=0.0004* *Least square mean based on an ANOVA model including treatment and sex as factors NORDITROPIN also significantly increased serum osteocalcin (a marker of osteoblastic activity). Study 2 A single center, randomized, double-blind, placebo-controlled, parallel-group, dose-finding, six month clinical trial was conducted in 49 men with CO GHD comparing the effects of NORDITROPIN and placebo on body composition. Patients were randomized to placebo or one of three active treatment groups (0.008, 0.016, and 0.024 mg/kg/day). Thirty three percent of the total dose to which each patient was randomized was administered during weeks 1-4, 67% during weeks 5-8, and 100% for the remainder of the study. The changes from baseline in LBM and percent TBF were measured by TBP after 6 months. Treatment with NORDITROPIN produced a significant increase from baseline in LBM compared to placebo (pooled data) ( Table 12 ). Table 12 – Lean Body Mass (kg) by TBP NORDITROPIN (n=36) Placebo (n=13) Baseline (mean) 48.18 48.90 Change from baseline at 6 months (mean) 2.06 0.70 Treatment difference (mean) 95% confidence interval p-value 1.40 (0.39, 2.41) p=0.0079* *Least square mean based on an ANOVA model including treatment as a factor Analysis of the treatment difference on the change from baseline in percent TBF revealed a significant decrease in the NORDITROPIN-treated groups (pooled data) compared to the placebo group ( Table 13 ). Table 13 – Total Body Fat (%) by TBP NORDITROPIN (n=36) Placebo (n=13) Baseline (mean) 34.55 34.07 Change from baseline at 6 months (mean) -6.00 -1.78 Treatment difference (mean) 95% confidence interval p-value -4.24 (-7.11, -1.37) p=0.0048* *Least square mean based on an ANOVA model including treatment as a factor"],"pharmacodynamics":["12.2 Pharmacodynamics Subcutaneous administration of a single dose of 4 mg NORDITROPIN in healthy subjects (n=26) with suppressed endogenous growth hormone results in an increased mean (SD) IGF-1 level from 190 (46) ng/mL predose to maximal level of 276 (49) ng/mL after approx. 24 hours. After 96 hours, the subjects displayed a mean (SD) IGF-1 concentration of 196 (41) ng/mL, comparable to the predose value."],"pharmacokinetics":["12.3 Pharmacokinetics Absorption - Somatropin has been studied following subcutaneous and intravenous administration in adult healthy subjects and GHD patients. A single dose administration of 4 mg NORDITROPIN in healthy subjects (n=26) with suppressed endogenous growth hormone resulted in a mean (SD) C max of 34.9 (10.4) ng/mL after approximately 3.0 hours. After a 180-min IV infusion of NORDITROPIN (33 ng/kg/min) administered to GHD patients (n=9), a mean (SD) hGH steady state serum level of approximately 23.1 (15.0) ng/mL was reached at 150 min. After a SC dose of 0.024 mg/kg or 3 IU/m 2 given in the thigh to adult GHD patients (n=18), mean (SD) C max values of 13.8 (5.8) and 17.1 (10.0) ng/mL were observed for the 4 and 8 mg NORDITROPIN vials, respectively, at approximately 4 to 5 hr. post dose. The absolute bioavailability for NORDITROPIN after the SC route of administration is currently not known. Distribution — The mean (SD) apparent volume of distribution of somatropin after single dose subcutaneous administration of 4 mg NORDITROPIN in healthy subjects is 43.9 (14.9) L. Elimination Metabolism — Extensive metabolism studies have not been conducted. The metabolic fate of somatropin involves classical protein catabolism in both the liver and kidneys. Excretion – The mean apparent terminal T 1/2 values in healthy adult subjects (n=26) was 2.0 (0.5) hours. In GHD patients receiving 180-min IV infusion of NORDITROPIN (33 ng/kg/min), a mean clearance rate of approximately 2.3 (1.8) mL/min/kg or 139 (105) mL/min for hGH was observed. Following infusion, serum hGH levels had a biexponential decay with a terminal elimination half-life (T 1/2 ) of approximately 21.1 (5.1) min. The mean apparent terminal T 1/2 values in GHD patients receiving a SC dose of 0.024 mg/kg or 3 IU/m 2 was estimated to be approximately 7 to 10 hr. The longer half-life observed after subcutaneous administration is due to slow absorption from the injection site. Urinary excretion of intact somatropin has not been measured. Geriatric patients — The pharmacokinetics of somatropin have not been studied in patients greater than 65 years of age. Pediatric patients — The pharmacokinetics of somatropin in pediatric patients are similar to those of adults. Male and Female Patients — No gender-specific pharmacokinetic studies have been performed with somatropin. The available literature indicates that the pharmacokinetics of somatropin are similar in men and women. Patients with Renal or Hepatic Impairment — No studies have been performed with somatropin."],"adverse_reactions":["6 ADVERSE REACTIONS The following important adverse reactions are also described elsewhere in the labeling: • Increased mortality in patients with acute critical illness [see Warnings and Precautions (5.1) ] • Sudden death in children with Prader-Willi syndrome [see Warnings and Precautions (5.2) ] • Neoplasms [see Warnings and Precautions (5.3) ] • Glucose intolerance and diabetes mellitus [see Warnings and Precautions (5.4) ] • Intracranial hypertension [see Warnings and Precautions (5.5) ] • Severe hypersensitivity [see Warnings and Precautions (5.6) ] • Fluid retention [see Warnings and Precautions (5.7) ] • Hypoadrenalism [see Warnings and Precautions (5.8) ] • Hypothyroidism [see Warnings and Precautions (5.9) ] • Slipped capital femoral epiphysis in pediatric patients [see Warnings and Precautions (5.10) ] • Progression of preexisting scoliosis in pediatric patients [see Warnings and Precautions (5.11) ] • Pancreatitis [see Warnings and Precautions (5.12) ] • Lipoatrophy [see Warnings and Precautions (5.13) ] Common adverse reactions in adult and pediatric patients include: upper respiratory infection, fever, pharyngitis, headache, otitis media, edema, arthralgia, paresthesia, myalgia, peripheral edema, flu syndrome, and impaired glucose tolerance. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk at 1-888-NOVO-444 (1-888-668-6444) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under varying conditions, adverse reaction rates observed during the clinical trials performed with one somatropin product cannot always be directly compared to the rates observed during the clinical trials performed with another somatropin product, and may not reflect the adverse reaction rates observed in practice. Pediatric Patients Growth Failure due to Inadequate Secretion of Endogenous Growth Hormone In one randomized, open label, clinical study the most frequent adverse reactions were headache, pharyngitis, otitis media and fever. There were no clinically significant differences between the three doses assessed in the study (0.025, 0.05 and 0.1 mg/kg/day). Short Stature Associated with Noonan Syndrome NORDITROPIN was studied in 21 pediatric patients, 3 years to 14 years of age at doses of 0.033 mg/kg/day and 0.066 mg/kg/day. After the two-year study, patients continued NORDITROPIN treatment until final height was achieved; randomized dose groups were not maintained. Adverse reactions were later collected retrospectively from 18 pediatric patients; total follow-up was 11 years. An additional 6 pediatric patients were not randomized, but followed the protocol and are included in this assessment of adverse reactions. The most frequent adverse reactions were upper respiratory infection, gastroenteritis, ear infection, and influenza. Cardiac disorders was the system organ class with the second most adverse reactions reported. Scoliosis was reported in 1 and 4 pediatric patients receiving doses of 0.033 mg/kg/day and 0.066 mg/kg/day respectively. The following additional adverse reactions also occurred once: insulin resistance and panic reaction for the 0.033 mg/kg/day dose group; injection site pruritus, bone development abnormal, depression, and self-injurious ideation in the 0.066 mg/kg/day dose group. Headache occurred in 2 cases in the 0.066 mg/kg/day dose group. Short Stature Associated with Turner Syndrome In two clinical studies in pediatric patients that were treated until final height with various doses of NORDITROPIN, the most frequently reported adverse reactions were influenza-like illness, otitis media, upper respiratory tract infection, otitis externa, gastroenteritis, eczema and, impaired fasting glucose. Adverse reactions in study 1 were most frequent in the highest dose groups. Three patients in study 1 had excessive growth of hands and/or feet in the high dose groups. Two patients in study 1 had a serious adverse reaction of exacerbation of preexisting scoliosis in the 0.045 mg/kg/day group. Small for Gestational Age (SGA) with No Catch-up Growth by Age 2-4 Years In a study, 53 pediatric patients were treated with 2 doses of NORDITROPIN (0.033 or 0.067 mg/kg/day) to final height for up to 13 years (mean duration of treatment 7.9 and 9.5 years for girls and boys, respectively). The most frequently reported adverse reactions were influenza-like illness, upper respiratory tract infection, bronchitis, gastroenteritis, abdominal pain, otitis media, pharyngitis, arthralgia, headache, gynecomastia, and increased sweating. One pediatric patient treated with 0.067 mg/kg/day for 4 years was reported with disproportionate growth of the lower jaw, and another patient treated with 0.067 mg/kg/day developed a melanocytic nevus. 4 pediatric patients treated with 0.067 mg/kg/day and 2 pediatric patients treated with 0.033 mg/kg/day of NORDITROPIN had increased fasting blood glucose levels after 1 year of treatment. In addition, small increases in mean fasting blood glucose and insulin levels after 1 and 2 years of NORDITROPIN treatment appeared to be dose-dependent. In a second study, 98 Japanese pediatric patients were treated with 2 doses of NORDITROPIN (0.033 or 0.067 mg/kg/day) for 2 years or were untreated for 1 year. Adverse reactions were otitis media, arthralgia and impaired glucose tolerance. Arthralgia and transiently impaired glucose tolerance were reported in the 0.067 mg/kg/day treatment group. Idiopathic Short Stature In two open-label clinical studies with another somatropin product in pediatric patients, the most common adverse reactions were upper respiratory tract infections, influenza, tonsillitis, nasopharyngitis, gastroenteritis, headaches, increased appetite, pyrexia, fracture, altered mood, and arthralgia. Growth Failure Due to Prader-Willi Syndrome In two clinical studies in pediatric patients with PWS carried out with another somatropin product, the following adverse reactions were reported: edema, aggressiveness, arthralgia, benign intracranial hypertension, hair loss, headache, and myalgia. Adult Patients Adults with Growth Hormone Deficiency Adverse reactions with an incidence of ≥5% occurring in patients with AO GHD during the 6 month placebo-controlled portion of a clinical trial for NORDITROPIN are presented in Table 1 . Table 1 – Adverse Reactions with ≥5% Overall Incidence in Adult Onset Growth Hormone Deficient Patients Treated with NORDITROPIN During a Six Month Placebo-Controlled Clinical Trial Placebo (N=52) NORDITROPIN (N=53) Adverse Reactions % % Peripheral Edema 8 42 Edema 0 25 Arthralgia 15 19 Leg Edema 4 15 Myalgia 8 15 Infection (non-viral) 8 13 Paraesthesia 6 11 Skeletal Pain 2 11 Headache 6 9 Bronchitis 0 9 Flu-like symptoms 4 8 Hypertension 2 8 Gastroenteritis 8 8 Other Non-Classifiable Disorders (excludes accidental injury) 6 8 Increased sweating 2 8 Glucose tolerance abnormal 2 6 Laryngitis 6 6 Type 2 diabetes mellitus 0 5 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of somatropin or NORDITROPIN. Because these adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure . Immune system disorders — Serious systemic hypersensitivity reactions including anaphylactic reactions and angioedema Skin — Increase in size or number of cutaneous nevi Endocrine disorders — Hypothyroidism - Gynecomastia Metabolism and nutrition disorders — Hyperglycemia Musculoskeletal and connective tissue disorders — Slipped capital femoral epiphysis and osteonecrosis (including Legg-Calvé-Perthes disease) have been reported in pediatric patients treated with growth hormone [see Warnings and Precautions (5.10)]. Cases have been reported with NORDITROPIN. Investigations — Increase in blood alkaline phosphatase level — Decrease in serum thyroxin (T4) levels Gastrointestinal — Pancreatitis Neoplasm — Leukemia has been reported in a small number of GH deficient children treated with somatropin, somatrem (methionylated rhGH) and GH of pituitary origin"],"contraindications":["4 CONTRAINDICATIONS NORDITROPIN is contraindicated in patients with: • Acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure due to the risk of increased mortality with use of pharmacologic doses of somatropin [see Warnings and Precautions (5.1) ]. • Pediatric patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment due to the risk of sudden death [see Warnings and Precautions (5.2) ]. • Active Malignancy [see Warnings and Precautions (5.3) ]. • Hypersensitivity to NORDITROPIN or any of its excipients. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropins [see Warnings and Precautions (5.6) ]. • Active proliferative or severe non-proliferative diabetic retinopathy. • Pediatric patients with closed epiphyses. • Acute Critical Illness ( 4 ) • Pediatric patients with Prader-Willi syndrome who are severely obese, have history of severe upper airway obstruction, or have severe respiratory impairment due to risk of sudden death ( 4 ) • Active Malignancy ( 4 ) • Hypersensitivity to somatropin or excipients ( 4 ) • Active Proliferative or Severe Non-Proliferative Diabetic Retinopathy ( 4 ) • Pediatric patients with closed epiphyses ( 4 )"],"description_table":["<table width=\"100%\"><col width=\"21%\"/><col width=\"18%\"/><col width=\"20%\"/><col width=\"20%\"/><col width=\"20%\"/><tbody><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Component</content></paragraph></td><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\">5 mg/1.5 mL</content></paragraph></td><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\">10 mg/1.5 mL</content></paragraph></td><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\">15 mg/1.5 mL</content></paragraph></td><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\">30 mg/3 mL</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Somatropin</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>5 mg</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>10 mg</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>15 mg</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>30 mg</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Histidine</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>1 mg</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>1 mg</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>1.7 mg</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>3.3 mg</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Mannitol</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>60 mg</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>60 mg</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>58 mg</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>117 mg</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Phenol</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>4.5 mg</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>4.5 mg</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>4.5 mg</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>9 mg</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Poloxamer 188</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>4.5 mg</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>4.5 mg</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>4.5 mg</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>9 mg</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Hydrochloric acid/sodium hydroxide </paragraph><paragraph>to adjust pH</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>as needed</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>as needed</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>as needed</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>as needed</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>Water for Injection, USP</paragraph></td><td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>up to 1.5 mL</paragraph></td><td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>up to 1.5 mL</paragraph></td><td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>up to 1.5 mL</paragraph></td><td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>up to 3 mL</paragraph></td></tr></tbody></table>"],"drug_interactions":["7 DRUG INTERACTIONS Table 2 includes a list of drugs with clinically important drug interactions when administered concomitantly with NORDITROPIN and instructions for preventing or managing them. Table 2: Clinically Important Drug Interactions with NORDITROPIN Glucocorticoids Clinical Impact: Microsomal enzyme 11β-hydroxysteroid dehydrogenase type 1 (11βHSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. NORDITROPIN inhibits 11βHSD-1. Consequently, individuals with untreated GH deficiency have relative increases in 11βHSD-1 and serum cortisol. Initiation of NORDITROPIN may result in inhibition of 11βHSD-1 and reduced serum cortisol concentrations. Intervention: Patients treated with glucocorticoid replacement for hypoadrenalism may require an increase in their maintenance or stress doses following initiation of NORDITROPIN [see Warnings and Precautions (5.8) ]. Examples: Cortisone acetate and prednisone may be effected more than others since conversion of these drugs to their biologically active metabolites is dependent on the activity of 11βHSD-1. Pharmacologic Glucocorticoid Therapy and Supraphysiologic Glucocorticoid Treatment Clinical Impact: Pharmacologic glucocorticoid therapy and supraphysiologic glucocorticoid treatment may attenuate the growth promoting effects of NORDITROPIN in pediatric patients. Intervention: Carefully adjust glucocorticoid replacement dosing in pediatric patients receiving glucocorticoid treatments to avoid both hypoadrenalism and an inhibitory effect on growth. Cytochrome P450-Metabolized Drugs Clinical Impact: Limited published data indicate that somatropin treatment increases cytochrome P450 (CP450)-mediated antipyrine clearance. NORDITROPIN may alter the clearance of compounds known to be metabolized by CP450 liver enzymes. Intervention: Careful monitoring is advisable when NORDITROPIN is administered in combination with drugs metabolized by CP450 liver enzymes. Oral Estrogen Clinical Impact: Oral estrogens may reduce the serum IGF-1 response to NORDITROPIN. Intervention: Patients receiving oral estrogen replacement may require greater NORDITROPIN dosages [see Dosage and Administration (2.3) ] . Insulin and/or Other Hypoglycemic Agents Clinical Impact: Treatment with NORDITROPIN may decrease insulin sensitivity, particularly at higher doses. Intervention: Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other hypoglycemic agents [see Warnings and Precautions (5.4) ]. • Glucocorticoids : Patients treated with glucocorticoid for hypoadrenalism may require an increase in their maintenance or stress doses following initiation of NORDITROPIN ( 7 ) • Pharmacologic Glucocorticoid Therapy and Supraphysiologic Glucocorticoid Treatment : Adjust glucocorticoid replacement dosing in pediatric patients receiving glucocorticoid treatment to avoid both hypoadrenalism and an inhibitory effect on growth. ( 7 ) • Cytochrome P450-Metabolized Drugs : NORDITROPIN may alter the clearance. Monitor carefully if used with NORDITROPIN ( 7 ) • Oral Estrogen : Larger doses of NORDITROPIN may be required ( 7 ) • Insulin and/or Other Hypoglycemic Agents : Dose adjustment of insulin or hypoglycemic agent may be required ( 5.4 , 7 )"],"how_supplied_table":["<table width=\"100%\"><col width=\"28%\"/><col width=\"36%\"/><col width=\"36%\"/><tbody><tr><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">Before Use</content></paragraph></td><td align=\"center\" colspan=\"2\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">In-use (After 1<sup>st</sup> injection)</content></paragraph></td></tr><tr><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">Storage</content></paragraph><paragraph><content styleCode=\"bold\">requirement</content></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">Storage Option 1</content></paragraph><paragraph><content styleCode=\"bold\">(Refrigeration)</content></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">Storage Option 2</content></paragraph><paragraph><content styleCode=\"bold\">(Room temperature)</content></paragraph></td></tr><tr><td align=\"center\" styleCode=\"Rrule Botrule Lrule \" valign=\"middle\"><paragraph>2&#xBA;C to 8&#xBA;C </paragraph><paragraph>(36&#xBA;F to 46&#xBA;F)</paragraph><paragraph>Until exp. date</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule \" valign=\"middle\"><paragraph>2&#xBA;C to 8&#xBA;C </paragraph><paragraph>(36&#xBA;F to 46&#xBA;F)</paragraph><paragraph>4 weeks</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule \" valign=\"middle\"><paragraph>Up to 25&#xBA;C (77&#xBA;F)</paragraph><paragraph>3 weeks</paragraph></td></tr></tbody></table>"],"mechanism_of_action":["12.1 Mechanism of Action Somatropin binds to dimeric GH receptors located within the cell membranes of target tissue cells. This interaction results in intracellular signal transduction and subsequent induction of transcription and translation of GH-dependent proteins including IGF-1, IGF BP-3 and acid-labile subunit. Somatropin has direct tissue and metabolic effects or mediated indirectly by IGF-1, including stimulation of chondrocyte differentiation, and proliferation, stimulation hepatic glucose output, protein synthesis and lipolysis. Somatropin stimulates skeletal growth in pediatric patients with GHD as a result of effects on the growth plates (epiphyses) of long bones. The stimulation of skeletal growth increases linear growth rate (height velocity) in most somatropin-treated pediatric patients. Linear growth is facilitated in part by increased cellular protein synthesis."],"instructions_for_use":["Instructions for Use – 5mg NORDITROPIN ® [nor-dee-tro-pin] (somatropin) injection, for subcutaneous use 5mg Norditropin FlexPro Pen is for single-patient-use only. Supplies you will need: • Norditropin FlexPro prefilled Pen new injection needle. Norditropin prefilled Pen is designed to be used with all Novo Nordisk disposable needles up to a length of 8 mm • sharps disposal container. See step 5 for information on how to throw away (dispose of) used needles and Pens. • alcohol pad • gauze pad How to use your Norditropin FlexPro Pen 5 steps you should follow for a Norditropin injection: Step 1: Prepare your Norditropin FlexPro Pen Step 2: Check the Norditropin flow with each new Pen Step 3: Select your dose Step 4: Inject your dose Step 5: After your injection For further information about your Pen see: Frequently Asked Questions Important information Patient Information ꜝImportant information Make sure that you read this information carefully. ꜟAdditional information Norditropin is for use under the skin only (subcutaneous). Do not share your Norditropin Pen and needles with another person. You may give another person an infection or get an infection from them. Do not use your Pen without proper training from your healthcare provider . Make sure that you are confident in giving an injection with the Pen before you start your treatment. If you are blind or have poor eyesight and cannot read the dose counter on the Pen, do not use this Pen without help. Get help from a person with good eyesight who is trained to use the Pen. Step 1. Prepare your Norditropin FlexPro Pen • Wash your hands with soap and water. • Check the name, strength, and colored label on your Pen to make sure that it contains Norditropin in the right strength. • Pull off the Pen cap. • Turn the Pen upside down 1 or 2 times to check that the Norditropin in your Pen is clear and colorless. See figure A. If the Norditropin looks cloudy, do not use the Pen. • When you are ready to give your injection, take a new disposable needle, and remove the paper tab. • Push the needle straight onto the Pen. Turn the needle clockwise until it is on tight . See figure B. ꜝAlways use a new needle for each injection. This reduces the risk of contamination, infection, leakage of Norditropin, and blocked needles leading to incorrect dosing. • Pull off the outer needle cap and dispose of it . See figure C. • Pull off the inner needle cap and dispose of it. See figure D. ꜟA drop of Norditropin may appear at the needle tip. This is normal, but you must still check the Norditropin flow with each new Pen. See step 2. ꜝNever use a bent or damaged needle. Step 2. Check the Norditropin flow with each new Pen ꜟ If your Pen is already in use , go to step 3. Before using a new Pen , check the Norditropin flow to make sure the growth hormone can flow through the Pen and needle. 1. Turn the dose selector clockwise 1 tick marking on the dose counter to select 0.025 mg. You will hear a faint “click” when you turn the dose selector. See figure E. • 1 marking on the dose counter equals 0.025 mg . See figure F. • Hold the Pen with the needle pointing up. Press and hold in the dose button until the dose counter returns to “0”. The “0” must line up with the dose pointer . See figure G. • Check that a drop of Norditropin appears at the needle tip. See figure H. ꜝIf no Norditropin appears , repeat step 2 up to 6 times. If you still do not see a drop of Norditropin, change the needle: 1. Carefully remove the needle from the Pen by turning the needle counterclockwise. Place the needle in a sharps disposal container immediately. See step 5. 2. and repeat step 2 again. Do not use the Pen if a drop of Norditropin still does not appear after changing the needle and repeating step 2. Call Novo Nordisk at 1-888-668-6444 for help. Step 3. Select your dose • To start, check that the dose pointer is set at “0”. • • Turn the dose selector clockwise to select the dose you need. See figure I. When you have selected your dose, you can go to step 4. ꜟ If there is not enough Norditropin left to select a full dose, see Frequently Asked Questions . ꜟThe dose counter shows the dose in “mg“. See figures J and K. Always use the dose counter to select the exact dose . Do not use the “click“ sounds you hear when you turn the dose selector or the Pen scale to select your dose. Only the dose pointer on the dose counter will show the exact dose selected. ꜟIf you select the wrong dose, you can turn the dose selector clockwise or counterclockwise to the correct dose. See figure L. The Pen “clicks” sound and feel differently when the dose selector is turned clockwise, counterclockwise, or if you forcefully move it past the number of “mg” left in the Pen. Step 4. Inject your dose • Select the injection site. • Norditropin can be injected under the skin (subcutaneously) of your stomach area (abdomen), buttocks, upper legs (thighs), or upper arms, as instructed by your healthcare provider. Change the injection site every day. • Wipe the injection site with an alcohol swab and let the area dry. • Insert the needle into your skin as your healthcare provider has shown you. See figure M. Make sure you can see the dose counter. Do not cover it with your fingers . This could block the injection. • Press and hold down the dose button until the dose counter shows “0”. See figure N. The “0” must line up with the dose pointer . You may then hear or feel a “click”. • Continue to hold the needle in your skin. ꜟIf “0” does not appear in the dose counter after continuously pressing the dose button, your needle may be blocked or damaged, see Frequently Asked Questions . • Keep the needle in your skin after the dose counter has returned to “0”. Count slowly to 6 to ensure that the full dose has been delivered. See figure O. • Carefully remove the needle from your skin. See figure P. If blood appears at the injection site, press lightly with a gauze pad. Do not rub the area. ꜟYou may see a drop of Norditropin at the needle tip after injecting. This is normal and does not affect your dose. Step 5. After your injection • Carefully remove the needle from the Pen by turning the needle counterclockwise. See figure Q. • Place the needle in a sharps disposal container immediately to reduce the risk of a needle stick. See figure R. ꜟAlways dispose of the needle after each injection. For further information about safe sharps disposal, see Frequently Asked Questions . ꜟDo not try to put the needle cap back on . You may stick yourself with the needle. • Put the Pen cap on your Pen after each use to protect the Norditropin from direct light. See figure S. See “How should I store Norditropin?” • Always remove the needle from your Pen. This reduces the risk of contamination, infection, leakage of Norditropin, and blocked needles leading to incorrect dosing. How should I store Norditropin? • Before you use Norditropin FlexPro pens for the first time: • Store your new, unused Norditropin pen in a refrigerator between 36ºF to 46ºF (2ºC to 8ºC). • Do not freeze Norditropin . • When stored in the refrigerator, do not store Norditropin directly next to the cooling element. • Keep Norditropin away from direct light. • Do not use Norditropin that has been frozen or in temperatures warmer than 77ºF (25ºC). • Do not use Norditropin after the expiration date printed on the carton and the pen. • After you use Norditropin FlexPro pens and there is still medicine left: • Store remaining Norditropin in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC) and use within 4 weeks, or • Store remaining Norditropin at room temperature no warmer than 77ºF (25ºC) and use within 3 weeks. Keep Norditropin and all medicines out of the reach of children. Frequently Asked Questions How do I see how much Norditropin is left in my Pen? The Pen scale shows you approximately how much Norditropin is left in your Pen. See figure T. To see how much Norditropin is left in your Pen, use the dose counter: Turn the dose selector clockwise until the dose counter stops. The dose pointer will line up with the number of “mg” left in the Pen. You can select a maximum dose of 2.0 mg. If the dose counter stops with the dose pointer lined up with “2.0”, at least 2.0 mg are left in your Pen. If the dose counter stops with the dose pointer lined up with “1.25”, only 1.25 mg are left in your Pen. See figure U. What if I need a larger dose than what is left in my Pen? It is not possible to select a larger dose on the dose counter than the number of “mg” left in your Pen. If you need more Norditropin than you have left in your Pen, you can use a new Pen or split your dose between your current Pen and a new Pen. Only split your dose if you have been trained or advised by your healthcare provider on how to do this. You may find it helpful to use a calculator to plan the doses as instructed by your healthcare provider. Be very careful to calculate your split dose correctly so that you do not give the wrong dose . If you are not sure how to split your dose using two Pens, then select and inject the dose you need with a new Pen. What if no Norditropin appears when I check the flow? A. Your needle may be blocked or damaged , if no Norditropin appears at the needle tip. Remove the needle as described in step 5 and repeat steps 1 and 2. B. Your Pen may be defective , if Norditropin still does not appear after changing the needle. Do not use the Pen. Contact Novo Nordisk at 1-888-668-6444. What if “0” does not appear after completing my injection? The needle may be blocked or damaged, and you have not received any Norditropin – even though the dose counter has moved from the dose that you have set. Remove the needle as described in step 5 and repeat steps 1 to 4. If “0” still does not appear after completing the injection, contact Novo Nordisk at 1-888-668-6444. How should I take care of my Pen? Be careful not to drop your Pen or knock it against hard surfaces. Do not expose your Pen to dust, dirt, liquid, or direct light. See “How should I store Norditropin?”. Do not try to refill your Pen, it is already prefilled. When your Pen is empty, throw it away and use a new pen. See “ How do I dispose of used needles and Pens? ”. Frequently Asked Questions What if I drop my Pen? If you drop your Pen or think that something is wrong with it, attach a new disposable needle and check the Norditropin flow before you inject, see steps 1 and 2. Do not try to repair your Pen or pull it apart. How do I clean my Pen? Do not wash, soak, or lubricate your Pen. If necessary, clean it with mild detergent on a moistened cloth. How do I dispose of used needles and Pens? Put your used needles in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles in your household trash . If you do not have an FDA-cleared sharps disposal container, you may use a household container that is: • made of a heavy-duty plastic, • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, • upright and stable during use, • leak-resistant, and • properly labeled to warn of hazardous waste inside the container. When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should dispose of used needles and Pens. For more information about safe sharps disposal, and for specific information about safe sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal . Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container. When there is not enough medicine left in your Pen for your prescribed dose, the Pen may be thrown away in your household trash after you have removed the needle. ꜟImportant information • Caregivers must be very careful when handling needles to reduce the risk of needle sticks and infection. • Norditropin ® FlexPro ® 5 mg/1.5 mL Pen is compatible with FlexPro ® PenMate ® . www.norditropin.com This Instructions for Use has been approved by the U.S. Food and Drug Administration. Norditropin ® and FlexPro ® are registered trademarks of Novo Nordisk Health Care AG. Novo Nordisk ® and PenMate ® are registered trademarks of Novo Nordisk A/S. PATENT Information: http://novonordisk-us.com/products/product-patents.html Manufactured by: Novo Nordisk Inc. 800 Scudders Mill Road Plainsboro, NJ 08536 U.S. License No. 1261 For information about NORDITROPIN ® Visit: norditropin.com Or call: 1 (888) 668-6444 Revised: 01/2025 © 2025 Novo Nordisk A/S 5mg-overview 5mg-needle-ex 5mg-supplies 5mg-a 5mg-b 5mg-c 5mg-d 5mg-e 5mg-f 5mg-g 5mg-h 5mg-i 5mg-j 5mg-k 5mg-l 5mg-m 5mg-n 5mg-o image-p 5mg-q 5mg-r 5mg-s 5mg-t 5mg-u phone-qrcode","Instructions for Use – 10mg INSTRUCTIONS FOR USE NORDITROPIN ® [nor-dee-tro-pin] (somatropin) injection, for subcutaneous use 10mg Norditropin FlexPro Pen is for single-patient-use only. Supplies you will need: • Norditropin FlexPro prefilled Pen new injection needle. Norditropin prefilled Pen is designed to be used with all Novo Nordisk disposable needles up to a length of 8 mm. • sharps disposal container. See step 5 for information on how to throw away (dispose of) used needles and Pens. • alcohol pad • gauze pad How to use your Norditropin FlexPro Pen 5 steps you should follow for a Norditropin injection: Step 1: Prepare your Norditropin FlexPro Pen Step 2: Check the Norditropin flow with each new Pen Step 3: Select your dose Step 4: Inject your dose Step 5: After your injection For further information about your Pen see: Frequently Asked Questions Important information Patient Information ꜝImportant information Make sure that you read this information carefully. ꜟAdditional information Norditropin is for use under the skin only (subcutaneous). Do not share your Norditropin Pen and needles with another person. You may give another person an infection or get an infection from them. Do not use your Pen without proper training from your healthcare provider . Make sure that you are confident in giving an injection with the Pen before you start your treatment. If you are blind or have poor eyesight and cannot read the dose counter on the Pen, do not use this Pen without help. Get help from a person with good eyesight who is trained to use the Pen. Step 1. Prepare your Norditropin FlexPro Pen • Wash your hands with soap and water. • Check the name, strength, and colored label on your Pen to make sure that it contains Norditropin in the right strength. • Pull off the Pen cap. • Turn the Pen upside down 1 or 2 times to check that the Norditropin in your Pen is clear and colorless. See figure A. If the Norditropin looks cloudy, do not use the Pen. • When you are ready to give your injection, take a new disposable needle, and remove the paper tab. • Push the needle straight onto the Pen. Turn the needle clockwise until it is on tight . See figure B. ꜟAlways use a new needle for each injection. This reduces the risk of contamination, infection, leakage of Norditropin, and blocked needles leading to incorrect dosing. • Pull off the outer needle cap and dispose of it . See figure C. • Pull off the inner needle cap and dispose of it. See figure D. ꜟA drop of Norditropin may appear at the needle tip. This is normal, but you must still check the Norditropin flow with each new Pen. See step 2. ꜝNever use a bent or damaged needle . Step 2. Check the Norditropin flow with each new Pen ꜟIf your Pen is already in use , go to step 3. Before using a new Pen , check the Norditropin flow to make sure the growth hormone can flow through the Pen and needle. 1. Turn the dose selector clockwise 1 tick marking on the dose counter to select 0.05 mg. You will hear a faint “click” when you turn the dose selector. See figure E. • 1 marking on the dose counter equals 0.05 mg . See figure F. • Hold the Pen with the needle pointing up. Press and hold in the dose button until the dose counter returns to “0”. The “0” must line up with the dose pointer . See figure G. • Check that a drop of Norditropin appears at the needle tip. See figure H. ꜟIf no Norditropin appears , repeat step 2 up to 6 times. If you still do not see a drop of Norditropin, change the needle: • Carefully remove the needle from the Pen by turning the needle counterclockwise. Place the needle in a sharps disposal container immediately. See step 5. • and repeat step 2 again. Do not use the Pen if a drop of Norditropin still does not appear after changing the needle and repeating step 2. Call Novo Nordisk at 1-888-668-6444 for help. Step 3. Select your dose • To start, check that the dose pointer is set at “0”. • Turn the dose selector clockwise to select the dose you need. See figure I. When you have selected your dose, you can go to step 4. ꜟIf there is not enough Norditropin left to select a full dose, see Frequently Asked Questions . ꜟThe dose counter shows the dose in “mg”. See figures J and K. Always use the dose counter to select the exact dose . Do not use the “click” sounds you hear when you turn the dose selector or the Pen scale to select your dose. Only the dose pointer on the dose counter will show the exact dose selected. ꜟIf you select the wrong dose, you can turn the dose selector clockwise or counterclockwise to the correct dose. See figure L. The Pen “clicks” sound and feel differently when the dose selector is turned clockwise, counterclockwise, or if you forcefully move it past the number of “mg” left in the Pen. Step 4. Inject your dose • Select the injection site. • Norditropin can be injected under the skin (subcutaneously) of your stomach area (abdomen), buttocks, upper legs (thighs), or upper arms, as instructed by your healthcare provider. Change the injection site every day . • Wipe the injection site with an alcohol swab and let the area dry. • Insert the needle into your skin as your healthcare provider has shown you. See figure M. Make sure you can see the dose counter. Do not cover it with your fingers . This could block the injection. • Press and hold down the dose button until the dose counter shows “0”. See figure N. The “0” must line up with the dose pointer . You may then hear or feel a “click”. • Continue to hold the needle in your skin. ꜟIf “0” does not appear in the dose counter after continuously pressing the dose button, your needle may be blocked or damaged, see Frequently Asked Questions . • Keep the needle in your skin after the dose counter has returned to “0”. Count slowly to 6 to ensure that the full dose has been delivered. See figure O. • Carefully remove the needle from your skin. See figure P. If blood appears at the injection site, press lightly with a gauze pad. Do not rub the area. ꜟYou may see a drop of Norditropin at the needle tip after injecting. This is normal and does not affect your dose. Step 5. After your injection • Carefully remove the needle from the Pen by turning the needle counterclockwise. See figure Q. • Place the needle in a sharps disposal container immediately to reduce the risk of a needle stick. See figure R. ꜟAlways dispose of the needle after each injection. For further information about safe sharps disposal, see Frequently Asked Questions . ꜝDo not try to put the needle cap back on . You may stick yourself with the needle. • Put the Pen cap on your Pen after each use to protect the Norditropin from direct light. See figure S. See “How should I store Norditropin?”. ꜝAlways remove the needle from your Pen. This reduces the risk of contamination, infection, leakage of Norditropin, and blocked needles leading to incorrect dosing. How should I store Norditropin? • Before you use Norditropin FlexPro pens for the first time: • Store your new, unused Norditropin pen in a refrigerator between 36ºF to 46ºF (2ºC to 8ºC). • Do not freeze Norditropin . • When stored in the refrigerator, do not store Norditropin directly next to the cooling element. • Keep Norditropin away from direct light. • Do not use Norditropin that has been frozen or in temperatures warmer than 77ºF (25ºC). • Do not use Norditropin after the expiration date printed on the carton and the pen. • After you use Norditropin FlexPro pens and there is still medicine left: • Store remaining Norditropin in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC) and use within 4 weeks, or • Store remaining Norditropin at room temperature no warmer than 77ºF (25ºC) and use within 3 weeks. Keep Norditropin and all medicines out of the reach of children. Frequently Asked Questions How do I see how much Norditropin is left in my Pen? The Pen scale shows you approximately how much Norditropin is left in your Pen. See figure T. To see how much Norditropin is left in your Pen, use the dose counter: Turn the dose selector clockwise until the dose counter stops. The dose pointer will line up with the number of “mg” left in the Pen. You can select a maximum dose of 4.0 mg. If the dose counter stops with the dose pointer lined up with “4.0”, at least 4.0 mg are left in your Pen. If the dose counter stops with the dose pointer lined up with “2.4”, only 2.4 mg are left in your Pen. See figure U. What if I need a larger dose than what is left in my Pen? It is not possible to select a larger dose on the dose counter than the number of “mg” left in your Pen. If you need more Norditropin than you have left in your Pen, you can use a new Pen or split your dose between your current Pen and a new Pen. Only split your dose if you have been trained or advised by your healthcare provider on how to do this. You may find it helpful to use a calculator to plan the doses as instructed by your healthcare provider. Be very careful to calculate your split dose correctly so that you do not give the wrong dose . If you are not sure how to split your dose using two Pens, then select and inject the dose you need with a new Pen. What if no Norditropin appears when I check the flow? A. Your needle may be blocked or damaged , if no Norditropin appears at the needle tip. Remove the needle as described in step 5 and repeat steps 1 and 2. B. Your Pen may be defective , if Norditropin still does not appear after changing the needle. Do not use the Pen. Contact Novo Nordisk at 1-888-668-6444. What if “0” does not appear after completing my injection? The needle may be blocked or damaged, and you have not received any Norditropin – even though the dose counter has moved from the dose that you have set. Remove the needle as described in step 5 and repeat steps 1 to 4. If “0” still does not appear after completing the injection, contact Novo Nordisk at 1-888-668-6444. How should I take care of my Pen? Be careful not to drop your Pen or knock it against hard surfaces. Do not expose your Pen to dust, dirt, liquid, or direct light. See “How should I store Norditropin?”. Do not try to refill your Pen, it is already prefilled. When your Pen is empty, throw it away and use a new pen. See “ How do I dispose of used needles and Pens? ”. Frequently Asked Questions What if I drop my Pen? If you drop your Pen or think that something is wrong with it, attach a new disposable needle and check the Norditropin flow before you inject, see steps 1 and 2. Do not try to repair your Pen or pull it apart. How do I clean my Pen? Do not wash, soak, or lubricate your Pen. If necessary, clean it with mild detergent on a moistened cloth. How do I dispose of used needles and Pens? Put your used needles in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles in your household trash . If you do not have an FDA-cleared sharps disposal container, you may use a household container that is: • made of a heavy-duty plastic, • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, • upright and stable during use, • leak-resistant, and • properly labeled to warn of hazardous waste inside the container. When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should dispose of used needles and Pens. For more information about safe sharps disposal, and for specific information about safe sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal. Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container. When there is not enough medicine left in your Pen for your prescribed dose, the Pen may be thrown away in your household trash after you have removed the needle. ꜝImportant information • Caregivers must be very careful when handling needles to reduce the risk of needle sticks and infection. • Norditropin ® FlexPro ® 10 mg/1.5 mL Pen is compatible with FlexPro ® PenMate ® . www.norditropin.com This Instructions for Use has been approved by the U.S. Food and Drug Administration. Norditropin ® and FlexPro ® are registered trademarks of Novo Nordisk Health Care AG. Novo Nordisk ® and PenMate ® are registered trademarks of Novo Nordisk A/S. PATENT Information: http://novonordisk-us.com/products/product-patents.html Manufactured by: Novo Nordisk Inc. 800 Scudders Mill Road Plainsboro, NJ 08536 USA U.S. License No. 1261 For information about NORDITROPIN ® Visit: norditropin.com Or call: 1 (888) 668-6444 Revised: 01/2025 © 2025 Novo Nordisk A/S 10mg-overview 10mg-example 10mg-supplies 10mg-a 10mg-b 10mg-c 10mg-d 10mg-e 10mg-f 10mg-g 10mg-h 10mg-i 10mg-j 10mg-k 10mg-l 10mg-m 10mg-n 10mg-o 10mg-p 10mg-q 10mg-r 10mg-s 10mg-t 10mg-u phone-qrcode.jpg","Instructions for Use – 15mg INSTRUCTIONS FOR USE NORDITROPIN ® [nor-dee-tro-pin] (somatropin) injection, for subcutaneous use 15mg Norditropin FlexPro Pen is for single-patient-use only. Supplies you will need: • Norditropin FlexPro prefilled Pen new injection needle. Norditropin prefilled Pen is designed to be used with all Novo Nordisk disposable needles up to a length of 8 mm • sharps disposal container. See step 5 for information on how to throw away (dispose of) used needles and Pens. • alcohol pad • gauze pad How to use your Norditropin FlexPro Pen 5 steps you should follow for a Norditropin injection: Step 1: Prepare your Norditropin FlexPro Pen Step 2: Check the Norditropin flow with each new Pen Step 3: Select your dose Step 4: Inject your dose Step 5: After your injection For further information about your Pen see: Frequently Asked Questions Important information Patient Information ꜝImportant information Make sure that you read this information carefully. ꜟ Additional information Norditropin is for use under the skin only (subcutaneous). Do not share your Norditropin Pen and needles with another person. You may give another person an infection or get an infection from them. Do not use your Pen without proper training from your healthcare provider . Make sure that you are confident in giving an injection with the Pen before you start your treatment. If you are blind or have poor eyesight and cannot read the dose counter on the Pen, do not use this Pen without help. Get help from a person with good eyesight who is trained to use the Pen. Step 1. Prepare your Norditropin FlexPro Pen • Wash your hands with soap and water. • Check the name, strength, and colored label on your Pen to make sure that it contains Norditropin in the right strength. • Pull off the Pen cap. • Turn the Pen upside down 1 or 2 times to check that the Norditropin in your Pen is clear and colorless. • See figure A. If the Norditropin looks cloudy, do not use the Pen. • When you are ready to give your injection, take a new disposable needle, and remove the paper tab. • Push the needle straight onto the Pen. Turn the needle clockwise until it is on tight . See figure B. ꜝAlways use a new needle for each injection. This reduces the risk of contamination, infection, leakage of Norditropin, and blocked needles leading to incorrect dosing. • Pull off the outer needle cap and dispose of it . See figure C. • Pull off the inner needle cap and dispose of it. See figure D. ꜟA drop of Norditropin may appear at the needle tip. This is normal, but you must still check the Norditropin flow with each new Pen. See step 2. ꜝNever use a bent or damaged needle . Step 2. Check the Norditropin flow with each new Pen ꜟIf your Pen is already in use , go to step 3. Before using a new Pen , check the Norditropin flow to make sure the growth hormone can flow through the Pen and needle. 1. Turn the dose selector clockwise 1 tick marking on the dose counter to select 0.1 mg. You will hear a faint “click” when you turn the dose selector. See figure E. • 1 marking on the dose counter equals 0.1 mg . See figure F. • Hold the Pen with the needle pointing up. Press and hold in the dose button until the dose counter returns to “0”. The “0” must line up with the dose pointer . See figure G. • Check that a drop of Norditropin appears at the needle tip. See figure H. ꜟIf no Norditropin appears , repeat step 2 up to 6 times. If you still do not see a drop of Norditropin, change the needle: • Carefully remove the needle from the Pen by turning the needle counterclockwise. Place the needle in a sharps disposal container immediately. See step 5. • and repeat step 2 again. Do not use the Pen if a drop of Norditropin still does not appear after changing the needle and repeating step 2. Call Novo Nordisk at 1-888-668-6444 for help. Step 3. Select your dose • To start, check that the dose pointer is set at “0”. • Turn the dose selector clockwise to select the dose you need. See figure I. When you have selected your dose, you can go to step 4. ꜟIf there is not enough Norditropin left to select a full dose, see Frequently Asked Questions . ꜟThe dose counter shows the dose in “mg”. See figures J and K. Always use the dose counter to select the exact dose . Do not use the “click” sounds you hear when you turn the dose selector or the Pen scale to select your dose.Only the dose pointer on the dose counter will show the exact dose selected. ꜟIf you select the wrong dose, you can turn the dose selector clockwise or counterclockwise to the correct dose. See figure L. The Pen “clicks” sound and feel differently when the dose selector is turned clockwise, counterclockwise, or if you forcefully move it past the number of “mg” left in the Pen. Step 4. Inject your dose • Select the injection site. • Norditropin can be injected under the skin (subcutaneously) of your stomach area (abdomen), buttocks, upper legs (thighs), or upper arms, as instructed by your healthcare provider. Change the injection site every day. • Wipe the injection site with an alcohol swab and let the area dry. • Insert the needle into your skin as your healthcare provider has shown you. See figure M. Make sure you can see the dose counter. Do not cover it with your fingers . This could block the injection. • Press and hold down the dose button until the dose counter shows “0”. See figure N. The “0” must line up with the dose pointer . You may then hear or feel a “click”. • Continue to hold the needle in your skin. ꜟIf “0” does not appear in the dose counter after continuously pressing the dose button, your needle may be blocked or damaged, see Frequently Asked Questions . • Keep the needle in your skin after the dose counter has returned to “0”. Count slowly to 6 to ensure that the full dose has been delivered. See figure O. • Carefully remove the needle from your skin. See figure P. If blood appears at the injection site, press lightly with a gauze pad. Do not rub the area. ꜟYou may see a drop of Norditropin at the needle tip after injecting. This is normal and does not affect your dose. Step 5. After your injection • Carefully remove the needle from the Pen by turning the needle counterclockwise. See figure Q. • Place the needle in a sharps disposal container immediately to reduce the risk of a needle stick. See figure R. ꜟAlways dispose of the needle after each injection. For further information about safe sharps disposal, see Frequently Asked Questions . ꜝDo not try to put the needle cap back on . You may stick yourself with the needle. • Put the Pen cap on your Pen after each use to protect the Norditropin from direct light. See figure S. See “How should I store Norditropin?”. ꜝAlways remove the needle from your Pen. This reduces the risk of contamination, infection, leakage of Norditropin, and blocked needles leading to incorrect dosing. How should I store Norditropin? • Before you use Norditropin FlexPro pens for the first time: • Store your new, unused Norditropin pen in a refrigerator between 36ºF to 46ºF (2ºC to 8ºC). • Do not freeze Norditropin . • When stored in the refrigerator, do not store Norditropin directly next to the cooling element. • Keep Norditropin away from direct light. • Do not use Norditropin that has been frozen or in temperatures warmer than 77ºF (25ºC). • Do not use Norditropin after the expiration date printed on the carton and the pen. • After you use Norditropin FlexPro pens and there is still medicine left: • Store remaining Norditropin in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC) and use within 4 weeks, or • Store remaining Norditropin at room temperature no warmer than 77ºF (25ºC) and use within 3 weeks. Keep Norditropin and all medicines out of the reach of children. Frequently Asked Questions How do I see how much Norditropin is left in my Pen? The Pen scale shows you approximately how much Norditropin is left in your Pen. See figure T. To see how much Norditropin is left in your Pen, use the dose counter: Turn the dose selector clockwise until the dose counter stops. The dose pointer will line up with the number of “mg” left in the Pen. You can select a maximum dose of 8.0 mg. If the dose counter stops with the dose pointer lined up with “8.0”, at least 8.0 mg are left in your Pen. If the dose counter stops with the dose pointer lined up with “3.8”, only 3.8 mg are left in your Pen. See figure U. What if I need a larger dose than what is left in my Pen? It is not possible to select a larger dose on the dose counter than the number of “mg” left in your Pen. If you need more Norditropin than you have left in your Pen, you can use a new Pen or split your dose between your current Pen and a new Pen. Only split your dose if you have been trained or advised by your healthcare provider on how to do this. You may find it helpful to use a calculator to plan the doses as instructed by your healthcare provider. Be very careful to calculate your split dose correctly so that you do not give the wrong dose . If you are not sure how to split your dose using two Pens, then select and inject the dose you need with a new Pen. What if no Norditropin appears when I check the flow? A. Your needle may be blocked or damaged , if no Norditropin appears at the needle tip. Remove the needle as described in step 5 and repeat steps 1 and 2. B. Your Pen may be defective , if Norditropin still does not appear after changing the needle. Do not use the Pen. Contact Novo Nordisk at 1-888-668-6444. What if “0” does not appear after completing my injection? The needle may be blocked or damaged, and you have not received any Norditropin – even though the dose counter has moved from the dose that you have set. Remove the needle as described in step 5 and repeat steps 1 to 4. If “0” still does not appear after completing the injection, contact Novo Nordisk at 1-888-668-6444. How should I take care of my Pen? Be careful not to drop your Pen or knock it against hard surfaces. Do not expose your Pen to dust, dirt, liquid, or direct light. See “ How should I store Norditropin?”. Do not try to refill your Pen, it is already prefilled. When your Pen is empty, throw it away and use a new pen. See “ How do I dispose of used needles and Pens? ”. Frequently Asked Questions What if I drop my Pen? If you drop your Pen or think that something is wrong with it, attach a new disposable needle and check the Norditropin flow before you inject, see steps 1 and 2. Do not try to repair your Pen or pull it apart. How do I clean my Pen? Do not wash, soak, or lubricate your Pen. If necessary, clean it with mild detergent on a moistened cloth. How do I dispose of used needles and Pens? Put your used needles in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles in your household trash . If you do not have an FDA-cleared sharps disposal container, you may use a household container that is: • made of a heavy-duty plastic, • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, • upright and stable during use, • leak-resistant, and • properly labeled to warn of hazardous waste inside the container. When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should dispose of used needles and Pens. For more information about safe sharps disposal, and for specific information about safe sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal . Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container. When there is not enough medicine left in your Pen for your prescribed dose, the Pen may be thrown away in your household trash after you have removed the needle. ꜟImportant information • Caregivers must be very careful when handling needles to reduce the risk of needle sticks and infection. • Norditropin ® FlexPro ® 15 mg/1.5 mL Pen is compatible with FlexPro ® PenMate ® . www.norditropin.com This Instructions for Use has been approved by the U.S. Food and Drug Administration. Norditropin ® and FlexPro ® are registered trademarks of Novo Nordisk Health Care AG. Novo Nordisk ® and PenMate ® are registered trademarks of Novo Nordisk A/S. PATENT Information: http://novonordisk-us.com/products/product-patents.html Manufactured by: Novo Nordisk Inc. 800 Scudders Mill Road Plainsboro, NJ 08536 U.S. License No. 1261 For information about NORDITROPIN ® Visit: norditropin.com Or call: 1 (888) 668-6444 Revised: 01/2025 © 2025 Novo Nordisk A/S 15mg-overview 15mg-example 15mg-supplies 15mg-a 15mg-b 15mg-c 15mg-d 15mg-e 15mg-f 15mg-g 15mg-h 15mg-i 15mg-j 15mg-k 15mg-l 15mg-m 15mg-n 15mg-o 15mg-p 15mg-q 15mg-r 15mg-s 15mg-t 15mg-u 15mg-phone-qrcode","Instructions for Use – 30mg INSTRUCTIONS FOR USE NORDITROPIN ® [nor-dee-tro-pin] (somatropin) injection, for subcutaneous use 30mg Norditropin FlexPro Pen is for single-patient-use only. Supplies you will need: • Norditropin FlexPro prefilled Pen new injection needle. Norditropin prefilled Pen is designed to be used with all Novo Nordisk disposable needles up to a length of 8 mm • sharps disposal container. See step 5 for information on how to throw away (dispose of) used needles and Pens. • alcohol pad • gauze pad How to use your Norditropin FlexPro Pen 5 steps you should follow for a Norditropin injection: Step 1: Prepare your Norditropin FlexPro Pen Step 2: Check the Norditropin flow with each new Pen Step 3: Select your dose Step 4: Inject your dose Step 5: After your injection For further information about your Pen see: Frequently Asked Questions Important information Patient Information ꜝImportant information Make sure that you read this information carefully. ꜟAdditional information Norditropin is for use under the skin only (subcutaneous). Do not share your Norditropin Pen and needles with another person. You may give another person an infection or get an infection from them. Do not use your Pen without proper training from your healthcare provider . Make sure that you are confident in giving an injection with the Pen before you start your treatment. If you are blind or have poor eyesight and cannot read the dose counter on the Pen, do not use this Pen without help. Get help from a person with good eyesight who is trained to use the Pen. Step 1. Prepare your Norditropin FlexPro Pen • Wash your hands with soap and water. • Check the name, strength, and colored label on your Pen to make sure that it contains Norditropin in the right strength. • Pull off the Pen cap. • Turn the Pen upside down 1 or 2 times to check that the Norditropin in your Pen is clear and colorless. See figure A. If the Norditropin looks cloudy, do not use the Pen. • When you are ready to give your injection, take a new disposable needle, and remove the paper tab. • Push the needle straight onto the Pen. Turn the needle clockwise until it is on tight . See figure B. ꜝAlways use a new needle for each injection. This reduces the risk of contamination, infection, leakage of Norditropin, and blocked needles leading to incorrect dosing. • Pull off the outer needle cap and dispose of it . See figure C. • Pull off the inner needle cap and dispose of it. See figure D. ꜟA drop of Norditropin may appear at the needle tip. This is normal, but you must still check the Norditropin flow with each new Pen. See step 2. ꜝNever use a bent or damaged needle. Step 2. Check the Norditropin flow with each new Pen ꜟIf your Pen is already in use , go to step 3. Before using a new Pen , check the Norditropin flow to make sure the growth hormone can flow through the Pen and needle. 1. Turn the dose selector clockwise 1 tick marking on the dose counter to select 0.1 mg. You will hear a faint “click” when you turn the dose selector. See figure E. • 1 marking on the dose counter equals 0.1 mg . See figure F. • Hold the Pen with the needle pointing up. Press and hold in the dose button until the dose counter returns to “0”. The “0” must line up with the dose pointer . See figure G. • Check that a drop of Norditropin appears at the needle tip. See figure H. ꜟIf no Norditropin appears , repeat step 2 up to 6 times. If you still do not see a drop of Norditropin, change the needle: • Carefully remove the needle from the Pen by turning the needle counterclockwise. Place the needle in a sharps disposal container immediately. See step 5. • and repeat step 2 again. Do not use the Pen if a drop of Norditropin still does not appear after changing the needle and repeating step 2. Call Novo Nordisk at 1-888-668-6444 for help. Step 3. Select your dose • To start, check that the dose pointer is set at “0”. • Turn the dose selector clockwise to select the dose you need. See figure I. When you have selected your dose, you can go to step 4. ꜟI f there is not enough Norditropin left to select a full dose, see Frequently Asked Questions . ꜟThe dose counter shows the dose in “mg”. See figures J and K. Always use the dose counter to select the exact dose . Do not use the “click” sounds you hear when you turn the dose selector or the Pen scale to select your dose. Only the dose pointer on the dose counter will show the exact dose selected. ꜟIf you select the wrong dose, you can turn the dose selector clockwise or counterclockwise to the correct dose. See figure L. The Pen “clicks” sound and feel differently when the dose selector is turned clockwise, counterclockwise, or if you forcefully move it past the number of “mg” left in the Pen. Step 4. Inject your dose • Select the injection site. • Norditropin can be injected under the skin (subcutaneously) of your stomach area (abdomen), buttocks, upper legs (thighs), or upper arms, as instructed by your healthcare provider. Change the injection site every day. • Wipe the injection site with an alcohol swab and let the area dry. • Insert the needle into your skin as your healthcare provider has shown you. See figure M. Make sure you can see the dose counter. Do not cover it with your fingers . This could block the injection. • Press and hold down the dose button until the dose counter shows “0”. See figure N. The “0” must line up with the dose pointer . You may then hear or feel a “click”. • Continue to hold the needle in your skin. ꜟIf “0” does not appear in the dose counter after continuously pressing the dose button, your needle may be blocked or damaged, see Frequently Asked Questions . • Keep the needle in your skin after the dose counter has returned to “0”. Count slowly to 6 to ensure that the full dose has been delivered. See figure O. • Carefully remove the needle from your skin. See figure P. If blood appears at the injection site, press lightly with a gauze pad. Do not rub the area. ꜟYou may see a drop of Norditropin at the needle tip after injecting. This is normal and does not affect your dose. Step 5. After your injection • Carefully remove the needle from the Pen by turning the needle counterclockwise. See figure Q. • Place the needle in a sharps disposal container immediately to reduce the risk of a needle stick. See figure R. ꜟAlways dispose of the needle after each injection. For further information about safe sharps disposal, see Frequently Asked Questions . ꜝDo not try to put the needle cap back on . You may stick yourself with the needle. • Put the Pen cap on your Pen after each use to protect the Norditropin from direct light. See figure S. See “How should I store Norditropin?”. ꜟAlways remove the needle from your Pen. This reduces the risk of contamination, infection, leakage of Norditropin, and blocked needles leading to incorrect dosing. How should I store Norditropin? • Before you use Norditropin FlexPro pens for the first time: 1. Store your new, unused Norditropin pen in a refrigerator between 36ºF to 46ºF (2ºC to 8ºC). 2. Do not freeze Norditropin . 3. When stored in the refrigerator, do not store Norditropin directly next to the cooling element. 4. Keep Norditropin away from direct light. 5. Do not use Norditropin that has been frozen or in temperatures warmer than 77ºF (25ºC). 6. Do not use Norditropin after the expiration date printed on the carton and the pen. • After you use Norditropin FlexPro pens and there is still medicine left: 7. Store remaining Norditropin in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC) and use within 4 weeks, or 8. Store remaining Norditropin at room temperature no warmer than 77ºF (25ºC) and use within 3 weeks. Keep Norditropin and all medicines out of the reach of children. Frequently Asked Questions How do I see how much Norditropin is left in my Pen? The Pen scale shows you approximately how much Norditropin is left in your Pen. See figure T. To see how much Norditropin is left in your Pen, use the dose counter: Turn the dose selector clockwise until the dose counter stops. The dose pointer will line up with the number of “mg” left in the Pen. You can select a maximum dose of 8.0 mg. If the dose counter stops with the dose pointer lined up with “8.0”, at least 8.0 mg are left in your Pen. If the dose counter stops with the dose pointer lined up with “3.8”, only 3.8 mg are left in your Pen. See figure U. What if I need a larger dose than what is left in my Pen? It is not possible to select a larger dose on the dose counter than the number of “mg” left in your Pen. If you need more Norditropin than you have left in your Pen, you can use a new Pen or split your dose between your current Pen and a new Pen. Only split your dose if you have been trained or advised by your healthcare provider on how to do this. You may find it helpful to use a calculator to plan the doses as instructed by your healthcare provider. Be very careful to calculate your split dose correctly so that you do not give the wrong dose . If you are not sure how to split your dose using two Pens, then select and inject the dose you need with a new Pen. What if no Norditropin appears when I check the flow? A. Your needle may be blocked or damaged , if no Norditropin appears at the needle tip. Remove the needle as described in step 5 and repeat steps 1 and 2. B. Your Pen may be defective , if Norditropin still does not appear after changing the needle. Do not use the Pen. Contact Novo Nordisk at 1-888-668-6444. What if “0” does not appear after completing my injection? The needle may be blocked or damaged, and you have not received any Norditropin – even though the dose counter has moved from the dose that you have set. Remove the needle as described in step 5 and repeat steps 1 to 4. If “0” still does not appear after completing the injection, contact Novo Nordisk at 1-888-668-6444. How should I take care of my Pen? Be careful not to drop your Pen or knock it against hard surfaces. Do not expose your Pen to dust, dirt, liquid, or direct light. See “ How should I store Norditropin?”. Do not try to refill your Pen, it is already prefilled. When your Pen is empty, throw it away and use a new pen. See “How do I dispose of used needles and Pens? ”. Frequently Asked Questions What if I drop my Pen? If you drop your Pen or think that something is wrong with it, attach a new disposable needle and check the Norditropin flow before you inject, see steps 1 and 2. Do not try to repair your Pen or pull it apart. How do I clean my Pen? Do not wash, soak, or lubricate your Pen. If necessary, clean it with mild detergent on a moistened cloth. How do I dispose of used needles and Pens? Put your used needles in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles in your household trash . If you do not have an FDA-cleared sharps disposal container, you may use a household container that is: • made of a heavy-duty plastic, • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, • upright and stable during use, • leak-resistant, and • properly labeled to warn of hazardous waste inside the container. When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should dispose of used needles and Pens. For more information about safe sharps disposal, and for specific information about safe sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal . Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container. When there is not enough medicine left in your Pen for your prescribed dose, the Pen may be thrown away in your household trash after you have removed the needle. ꜟImportant information • Caregivers must be very careful when handling needles to reduce the risk of needle sticks and infection. • Norditropin ® FlexPro ® 30 mg/3 mL Pen is not compatible with FlexPro ® PenMate ® . www.norditropin.com This Instructions for Use has been approved by the U.S. Food and Drug Administration. Norditropin ® and FlexPro ® are registered trademarks of Novo Nordisk Health Care AG. Novo Nordisk ® and PenMate ® are registered trademarks of Novo Nordisk A/S. PATENT Information: http://novonordisk-us.com/products/product-patents.html Manufactured by: Novo Nordisk Inc. 800 Scudders Mill Road Plainsboro, NJ 08536 U.S. License No. 1261 For information about NORDITROPIN ® Visit: norditropin.com Or call: 1 (888) 668-6444 Revised: 01/2025 © 2025 Novo Nordisk A/S 30mg-overview 30mg-needle-example 30mg-supplies 30mg-a 30mg-b 30mg-c 30mg-d 30mg-e 30mg-f 30mg-g 30mg-h 30mg-i 30mg-j 30mg-k 30mg-l 30mg-m 30mg-n 30mg-o. 30mg-p 30mg-q 30mg-r 30mg-s 30mg-t 30mg-u 30mg-phoneqrcode","Instructions for Use - PenMate INSTRUCTIONS FOR USE Norditropin ® (nor-dee-tro-pin) FlexPro ® (somatropin) injection prefilled pen with PenMate ® and Sogroya ® (suh-GROY-uh) (somapacitan-beco) injection prefilled pen with PenMate ® Read this Instructions for Use before you start using your Pen with PenMate. • PenMate hides the needle when you inject your Norditropin growth hormone with Norditropin FlexPro 5 mg/1.5 mL, 10 mg/1.5 mL, and 15 mg/1.5 mL Pens or Sogroya growth hormone with Sogroya 5 mg/1.5 mL, 10 mg/1.5 mL, and 15 mg/1.5 mL Pens, so that you cannot see the needle. • Use your PenMate only after you have been trained by a healthcare provider. • People who are blind or have poor eyesight should only use the PenMate and Pen with help from a person with good eyesight who is trained to use the PenMate and Pen. • The figures in this Instructions for Use show PenMate being used with a Norditropin FlexPro 5 mg/1.5 mL Pen and a NovoFine needle that is 8 mm long. Even if you are using a Norditropin FlexPro 10 mg/1.5 mL or 15 mg/1.5 mL Pen or a Sogroya 5 mg/1.5 mL, 10 mg/1.5 mL, or 15 mg/1.5 mL Pen or a different needle that is 8 mm long, the instructions are the same. • Do not share your Norditropin FlexPro or Sogroya Pens and needles with another person. You may give another person an infection or get an infection from them. Supplies you will need to use your Pen with PenMate: • 1 PenMate. See Figure A. • 1 Norditropin FlexPro Pen or Sogroya Pen. See Figure B. PenMate does not work with other injection devices. • 1 disposable needle up to 8 mm long .See FigureC. Needles are not included with your PenMate or Pen. • 2 alcohol swabs. See Figure C. • a sharps disposal container. See Figure C. See “How should I dispose of my Pen and needles” at the end of these instructions for information on how to throw away (dispose of) used Pens and needles. Pen: This pen represents Norditropin FlexPro 5 mg/1.5 mL, 10 mg/1.5 mL or 15 mg/1.5 mL Pen and Sogroya 5 mg/1.5 mL, 10 mg/1.5 mL, and 15 mg/1.5 mL Pen Needle parts and supplies: Pen case Step 1: Preparing your PenwithPenMate: Wash your hands with soap and water and dry them. Check the name and the colored label on your Pen to make sure it contains the growth hormone strength prescribed by your healthcare provider. Pull off the PenMate cap. See Figure E. Pull off the Pen cap and throw it away. See Figure F. You will not need the Pen cap with your PenMate. Look in the Pen window. Check the liquid medicine in your Pen by turning it upside down 1 or 2 times. See Figure G. • Norditropin FlexPro Pen : the liquid in the Norditropin FlexPro Pen should be clear and colorless. If the liquid looks cloudy or you see particles, do not use the Norditropin FlexPro Pen . • Sogroya Pen : the liquid in the Sogroya Pen should be clear to almost clear and colorless to slightly yellow. If the liquid looks cloudy or you see particles, do not use the Sogroya Pen . Wipe the front stopper on the needle thread of the Pen with an alcohol swab. See Figure H. Insert the Pen into the PenMate. Twist the Pen clockwise until you hear or feel a click. See Figure I. The Pen is correctly attached in your PenMate when the display window on the Pen lines up with the insertion button on your PenMate. Step 2. Attaching the needle to your Pen: • Do not place a needle on your Pen until you are ready to give an injection. • Always use a new needle for each injection. • Do not use a bent or damaged needle. Get a new disposable needle and tear off the paper tab. See Figure J. Holding the Pen with 1 hand, firmly press the needle onto the needle thread of the Pen. Screw the needle in a clockwise direction until the needle will not turn anymore. See Figure K. Pull off the outer needle cap and save it. See Figure L. You will need the outer needle cap after the injection so you can safely remove the needle from the Pen. Pull off the inner needle cap and throw it away. See Figure M. A drop of liquid may appear at the needle tip. This is normal. Step 3. Priming a new Pen: Checking the growth hormone flow in the Pen (priming) is not needed for a Pen you have used before. If the Pen has already been primed, go to Step 4. Before you use a new Pen you must prepare it for use. Hold the Pen with 1 hand and turn the dose selector clockwise 1 marking to select the minimumdose. See Figure N. You may hear or feel a click when you turn the dose selector. When you turn the dose selector 1 marking, you select the smallest amount of medicine for a dose. See Figure O. This lowest dose will be used for your Norditropin or Sogroya flow check dose. Hold your Pen with PenMate with the needle pointing up. You may see air bubbles in the PenMate window. Gently tap the top of PenMate a few times to let any air bubbles rise to the top. See Figure P. Press the dose button until the dose pointer lines up with the “0” in the display window on the Pen and a drop of liquid appears at the needle tip. See Figure Q. If no drop of liquid appears at the needle tip, repeat Step 3 again up to 6 times. If there is still no drop of liquid at the needle tip, change the needle and repeat Step 3 again. If a drop of liquid still does not appear at the needle tip after repeating Step 3 and changing the needle, call Novo Nordisk at 1-888-668-6444 for help. Step 4. Selecting the correct dose of Norditropin or Sogroya: Use the dose selector on your Pen to make sure you have the exact dose selected. Your dose will be in a certain number of mg (milligrams). To start, check that the dose pointer on the Pen is set at “0”. Select the dose you need by turning the dose selector clockwise. If you move past your dose, turn the dose selector counterclockwise until the right number of mg lines up with the dose pointer. See Figure R. To guide you, the dose selector click sound is different when turned clockwise (softer click) or counterclockwise (louder click). You will hear a click for every single unit dialed. When dialing counterclockwise, be careful not to press the dose button as liquid will come out. You can use the growth hormone scale on the side of the Pen to see about how much growth hormone is left in the Pen. You can also use the dose selector to see exactly how much growth hormone is left in the Pen. If the Pen contains less than 2 mg, 4 mg, or 8 mg (depending on whether you use a 5 mg/1.5 mL, 10 mg/1.5 mL, or 15 mg/1.5 mL Pen), turn the dose selector until it stops. The number that lines up with the dose pointer shows how many mg are left in the Pen. You cannot set a dose higher than the number of mg left in the Pen. If there is not enough Norditropin or Sogroya left in the Pen for your full dose, use a new Norditropin FlexPro Pen or Sogroya Pen to inject the remaining amount of your dose or contact your healthcare provider. Remember to subtract the dose already received. For example, if the dose is 0.7 mg and you can only set the dose selector to 0.35 mg, you should inject another 0.35 mg with a new Norditropin FlexPro Pen or Sogroya Pen. Important: • Do not use the Pen clicks to count the number of mg you select. Only the display window and dose pointer will show the exact number. • Do not use the growth hormone scale to measure how much liquid to inject. Only the display window and dose pointer will show the exact number. Step 5. Selecting your injection site and injecting the dose of Norditropin or Sogroya: Change your injection site every day. Select the injection site and wipe your skin with an alcohol swab as your healthcare provider showed you. Norditropin or Sogroya can be injected under your skin (subcutaneously) of your buttocks, stomach area (abdomen), upper legs (thighs), upper arms, or as instructed by your healthcare provider. See Figure S. Hold onto both the PenMate and your Pen without touching the insertion button on the PenMate or the dose button on the Pen. Do not press the insertion button on the PenMate before you are ready to inject your dose. This lowers the risk of hurting yourself with the needle. Hold the PenMate firmly with 1 hand and pull the Pen out with your other hand until you hear and feel a click. See Figure T. The needle is now hidden in PenMate. Norditropin and Sogroya is for use under your skin only (subcutaneous). Hold the PenMate against your skin. Press the insertion button on the PenMate until you hear or feel a click. When you hear or feel the click, the needle has been inserted automatically into your skin. See Figure U. You are now ready to inject your dose. Press the dose button on the Pen to inject your dose.Do not turn the dose button while you are pressing it. If you turn the dose button, you will not inject growth hormone. Make sure you can see the display window. Do not cover it with your fingers. Press and hold down the dose button on the Pen until the display window returns to “0”. The “0” must line up with the dose pointer. You may then hear or feel a firm click. After the display window has returned to “0”, leave the needle under your skin for at least 6 seconds to make sure you get your full dose. See Figure V. Let go of the dose button while you wait. See Figure V . If the dose button cannot be pushed in completely or “0” does not appear in the display window, you did not receive the full dose. Call Novo Nordisk at 1-888-668-6444 for help. You may need a new Pen. Important: Always press the dose button to inject the dose. Turning the dose selector will not inject the dose. Do not touch the display window when you inject, as this can block the injection. Carefully lift the Pen to remove the needle from the skin. See Figure W. Step 6. What to do after your injection is completed: Carefully put the outer needle cap back on the needle. Remove the needle from the Pen after each injection. See Figure X. Unscrew the needle by turning it counterclockwise. Do not touch the needle. Hold the Pen with 1 hand and carefully remove the needle from the Pen with your other hand. See Figure Y. Throw away (dispose of) the needle. See “How should I dispose of my Pen and needles?” at the end of these instructions. Put the PenMate cap back on your PenMate after each use to protect the growth hormone from direct light. See Figure Z. Important safety information to remember: • Be careful not to drop your PenMate and Pen or knock them against a hard surface. If this happens you will need to check the growth hormone flow. • Do not try to put the inner needle cap back on the needle. You may stick yourself with the needle. Be careful when handling used needles to avoid needle stick injuries. • After each use always remove and throw away (dispose of) the needle from your Pen. • Do not share your Pen or needles with other people. • If your PenMate is damaged or lost, you can still use your Pen without your PenMate. • Always keep your Pen and needles out of reach of others, especially children. How should I replace an empty Pen? PenMate is reusable and should not be thrown away (disposed of). Reuse your PenMate by replacing your Pen when it is empty. When your Pen is empty, twist the Pen counterclockwise until you hear or feel a click. See Figure AA. Gently pull the Pen out of PenMate. See Figure BB. Before throwing away (disposing of) your empty Pen, make sure the needle has been removed. See “How should I dispose of my Pen and needles?” at the end of these instructions. Insert the new Pen into your PenMate. See Figure CC. Twist the Pen clockwise until you hear or feel a click. See Figure DD. The Pen is correctly attached in your PenMate when the display window on the Pen lines up with the insertion button on your PenMate. How should I store my PenMate and Pen? • Do not expose your PenMate or Pen to dust, dirt, liquid, or direct light. • Store your PenMate and Pen in their case. See Figure D at the beginning of these instructions. • When your Pen is inserted in PenMate, store it as described in the Patient Information leaflet that comes with your Pen. How should I care for and clean my Pen with PenMate? • Do not try to refill your Pen. It is prefilled. • Do not try to repair your PenMate or your Pen. • Only clean your PenMate or Pen with a mild detergent on a moistened cloth. • Do not wash, soak, or lubricate your PenMate or Pen. Do not use products containing bleaching agents, such as chlorine, iodine, or alcohol to clean your PenMate or Pen. These products may damage them. • If there is liquid growth hormone on the outside of your PenMate or Pen, clean it with a mild detergent on a moistened cloth before it dries up. How should I throw away (dispose of) my Pen and needles? • Put your used needles and Pens in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and Pens in your household trash. • If you do not have a FDA-cleared sharps disposal container, you may use a household container that is: • made of a heavy-duty plastic, • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, • upright and stable during use, • leak-resistant, and • properly labeled to warn of hazardous waste inside the container. • When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and Pens. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal. • Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container. Need help? PenMate must only be used according to the instructions provided. The manufacturer cannot be held responsible for any problems with PenMate if these instructions have not been followed. If you find that your PenMate or case is defective, make sure to have Novo Nordisk replace it. Call the number below to order a new PenMate or case and arrange return of the defective item for inspection. For help or further information, write to: Novo Nordisk Inc. 800 Scudders Mill Road Plainsboro, NJ 08536, USA Visit norditropin.com or sogroya.com Or call: 1-888-668-6444 PATENT Information: http://novonordisk-us.com/products/product-patents.html Novo Nordisk ® , PenMate ® and NovoFine ® are registered trademarks of Novo Nordisk A/S Norditropin ® , Sogroya ® and FlexPro ® are registered trademarks of Novo Nordisk Health Care AG. © 2025 Novo Nordisk A/S Manufactured by: Novo Nordisk A/S Novo Allé DK-2880 Bagsvaerd Denmark This Instructions for Use has been approved by the U.S. Food and Drug Administration. Issued: 01/2025 fig-a.jpg fig-b fig-c fig-d fig-e fig-f fig-g fig-h fig-i fig-j fig-k fig-l fig-m fig-n fig-o fig-p fig-q fig-r fig-s fig-t fig-u fig-v fig-w fig-x fig-y fig-z fig-aa fig-bb fig-cc fig-dd"],"recent_major_changes":["Warnings and Precautions, Slipped Capital Femoral Epiphysis in Pediatric Patients ( 5.10 )…..07/2025"],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Somatropin binds to dimeric GH receptors located within the cell membranes of target tissue cells. This interaction results in intracellular signal transduction and subsequent induction of transcription and translation of GH-dependent proteins including IGF-1, IGF BP-3 and acid-labile subunit. Somatropin has direct tissue and metabolic effects or mediated indirectly by IGF-1, including stimulation of chondrocyte differentiation, and proliferation, stimulation hepatic glucose output, protein synthesis and lipolysis. Somatropin stimulates skeletal growth in pediatric patients with GHD as a result of effects on the growth plates (epiphyses) of long bones. The stimulation of skeletal growth increases linear growth rate (height velocity) in most somatropin-treated pediatric patients. Linear growth is facilitated in part by increased cellular protein synthesis. 12.2 Pharmacodynamics Subcutaneous administration of a single dose of 4 mg NORDITROPIN in healthy subjects (n=26) with suppressed endogenous growth hormone results in an increased mean (SD) IGF-1 level from 190 (46) ng/mL predose to maximal level of 276 (49) ng/mL after approx. 24 hours. After 96 hours, the subjects displayed a mean (SD) IGF-1 concentration of 196 (41) ng/mL, comparable to the predose value. 12.3 Pharmacokinetics Absorption - Somatropin has been studied following subcutaneous and intravenous administration in adult healthy subjects and GHD patients. A single dose administration of 4 mg NORDITROPIN in healthy subjects (n=26) with suppressed endogenous growth hormone resulted in a mean (SD) C max of 34.9 (10.4) ng/mL after approximately 3.0 hours. After a 180-min IV infusion of NORDITROPIN (33 ng/kg/min) administered to GHD patients (n=9), a mean (SD) hGH steady state serum level of approximately 23.1 (15.0) ng/mL was reached at 150 min. After a SC dose of 0.024 mg/kg or 3 IU/m 2 given in the thigh to adult GHD patients (n=18), mean (SD) C max values of 13.8 (5.8) and 17.1 (10.0) ng/mL were observed for the 4 and 8 mg NORDITROPIN vials, respectively, at approximately 4 to 5 hr. post dose. The absolute bioavailability for NORDITROPIN after the SC route of administration is currently not known. Distribution — The mean (SD) apparent volume of distribution of somatropin after single dose subcutaneous administration of 4 mg NORDITROPIN in healthy subjects is 43.9 (14.9) L. Elimination Metabolism — Extensive metabolism studies have not been conducted. The metabolic fate of somatropin involves classical protein catabolism in both the liver and kidneys. Excretion – The mean apparent terminal T 1/2 values in healthy adult subjects (n=26) was 2.0 (0.5) hours. In GHD patients receiving 180-min IV infusion of NORDITROPIN (33 ng/kg/min), a mean clearance rate of approximately 2.3 (1.8) mL/min/kg or 139 (105) mL/min for hGH was observed. Following infusion, serum hGH levels had a biexponential decay with a terminal elimination half-life (T 1/2 ) of approximately 21.1 (5.1) min. The mean apparent terminal T 1/2 values in GHD patients receiving a SC dose of 0.024 mg/kg or 3 IU/m 2 was estimated to be approximately 7 to 10 hr. The longer half-life observed after subcutaneous administration is due to slow absorption from the injection site. Urinary excretion of intact somatropin has not been measured. Geriatric patients — The pharmacokinetics of somatropin have not been studied in patients greater than 65 years of age. Pediatric patients — The pharmacokinetics of somatropin in pediatric patients are similar to those of adults. Male and Female Patients — No gender-specific pharmacokinetic studies have been performed with somatropin. The available literature indicates that the pharmacokinetics of somatropin are similar in men and women. Patients with Renal or Hepatic Impairment — No studies have been performed with somatropin. 12.6 Immunogenicity The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies, including those of NORDITROPIN or other somatropins. In the case of growth hormone, antibodies with binding capacities lower than 2 mg/mL have not been associated with growth attenuation. In a very small number of patients treated with somatropin, when binding capacity was greater than 2 mg/mL, interference with the growth response was observed. In clinical trials, GH deficient pediatric patients receiving NORDITROPIN for up to 12 months were tested for induction of antibodies, and 0 of 358 patients developed antibodies with binding capacities above 2 mg/L. Amongst these patients, 165 had previously been treated with other somatropin formulations, and 193 were previously untreated naive patients. Eighteen of 76 children (~24%) treated with NORDITROPIN for short stature born SGA developed anti-rhGH antibodies."],"indications_and_usage":["1 INDICATIONS AND USAGE NORDITROPIN is a recombinant human growth hormone indicated for: • Pediatric : Treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone (GH), short stature associated with Noonan syndrome, short stature associated with Turner syndrome, short stature born small for gestational age (SGA) with no catch-up growth by age 2 to 4 years, Idiopathic Short Stature (ISS), and growth failure due to Prader-Willi Syndrome ( 1.1 ) • Adult : Replacement of endogenous GH in adults with growth hormone deficiency ( 1.2 ) 1.1 Pediatric Patients NORDITROPIN is indicated for the treatment of pediatric patients with: • growth failure due to inadequate secretion of endogenous growth hormone (GH), • short stature associated with Noonan syndrome, • short stature associated with Turner syndrome, • short stature born small for gestational age (SGA) with no catch-up growth by age 2 years to 4 years of age, • Idiopathic Short Stature (ISS), height standard deviation score (SDS) <-2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range, • growth failure due to Prader-Willi syndrome (PWS). 1.2 Adult Patients NORDITROPIN is indicated for the replacement of endogenous GH in adults with growth hormone deficiency (GHD)"],"warnings_and_cautions":["5 WARNINGS AND PRECAUTIONS • Increased Risk of Neoplasms : Second neoplasms have occurred in childhood cancer survivors. Monitor patients with preexisting tumors for progression or recurrence. ( 5.3 ) • Glucose Intolerance and Diabetes Mellitus : NORDITROPIN may decrease insulin sensitivity, particularly at higher doses. Monitor glucose levels periodically in all patients receiving NORDITROPIN, especially in patients with existing diabetes mellitus or at risk for development. ( 5.4 ) • Intracranial Hypertension (IH) : Has been reported usually within 8 weeks of initiation. Perform fundoscopic examinations prior to initiation and periodically thereafter. If papilledema occurs, stop treatment. ( 5.5 ) • Severe Hypersensitivity : Serious hypersensitivity reactions may occur. In the event of an allergic reaction, seek prompt medical attention. ( 5.6 ) • Fluid Retention : May occur in adults and may be dose dependent. ( 5.7 ) • Hypoadrenalism : Monitor patients for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism. ( 5.8 ) • Hypothyroidism : Monitor thyroid function periodically as hypothyroidism may occur or worsen after initiation of somatropin. ( 5.9 ) • Slipped Capital Femoral Epiphysis in Pediatric Patients : May occur; evaluate patients with onset of a limp or hip/knee pain. ( 5.10 ) • Progression of Preexisting Scoliosis in Pediatric Patients : Monitor patients with scoliosis for progression. ( 5.11 ) • Pancreatitis : Has been reported; consider pancreatitis in patients with abdominal pain, especially pediatric patients. ( 5.12 ) 5.1 Increased Mortality in Patients with Acute Critical Illness Increased mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure has been reported after treatment with pharmacologic amounts of somatropin [see Contraindications (4) ]. Two placebo-controlled clinical trials in non-growth hormone deficient adult patients (n=522) with these conditions in intensive care units revealed a significant increase in mortality (42% vs. 19%) among somatropin-treated patients (doses 5.3-8 mg/day) compared to those receiving placebo. The safety of continuing NORDITROPIN treatment in patients receiving replacement doses for approved indications who concurrently develop these illnesses has not been established. NORDITROPIN is not indicated for the treatment of non-GH deficient adults. 5.2 Sudden Death in Pediatric Patients with Prader-Willi Syndrome There have been reports of sudden death after initiating therapy with somatropin in pediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection. Male patients with one or more of these factors may be at greater risk than females. Patients with Prader-Willi syndrome should be evaluated for signs of upper airway obstruction and sleep apnea before initiation of treatment with somatropin. If, during treatment with NORDITROPIN, patients show signs of upper airway obstruction (including onset of or increased snoring) and/or new onset sleep apnea, treatment should be interrupted. All patients with Prader-Willi syndrome treated with NORDITROPIN should also have effective weight control and be monitored for signs of respiratory infection, which should be diagnosed as early as possible and treated aggressively [see Contraindications (4) ] . 5.3 Increased Risk of Neoplasms Active Malignancy There is an increased risk of malignancy progression with somatropin treatment in patients with active malignancy [See Contraindications (4) ]. Any preexisting malignancy should be inactive and its treatment complete prior to instituting therapy with NORDITROPIN. Discontinue NORDITROPIN if there is evidence of recurrent activity. Risk of Second Neoplasm in Pediatric Patients There is an increased risk of a second neoplasm in pediatric cancer survivors who were treated with radiation to the brain/head and who developed subsequent GH deficiency and were treated with somatropin. Intracranial tumors, in particular meningiomas, were the most common of these second neoplasms. In adults, it is unknown whether there is any relationship between somatropin replacement therapy and CNS tumor recurrence. Monitor all patients receiving NORDITROPIN who have a history of GH deficiency secondary to an intracranial neoplasm for progression or recurrence of the tumor. New Malignancy During Treatment Because pediatric patients with certain rare genetic causes of short stature have an increased risk of developing malignancies, thoroughly consider the risks and benefits of starting NORDITROPIN in these patients. If NORDITROPIN is initiated, carefully monitor patients for development of neoplasms. Monitor all patients receiving NORDITROPIN carefully for increased growth, or potential malignant changes, of preexisting nevi. Advise patients/caregivers to report marked changes in behavior, onset of headaches, vision disturbances and/or changes in skin pigmentation or changes in the appearance of pre-existing nevi. 5.4 Glucose Intolerance and Diabetes Mellitus Treatment with somatropin may decrease insulin sensitivity, particularly at higher doses. New onset type 2 diabetes mellitus has been reported in patients taking somatropin. Previously undiagnosed impaired glucose tolerance and overt diabetes mellitus may be unmasked. Monitor glucose levels periodically in all patients receiving NORDITROPIN, especially in those with risk factors for diabetes mellitus, such as obesity, Turner syndrome, or a family history of diabetes mellitus. Patients with preexisting type 1 or type 2 diabetes mellitus or impaired glucose tolerance should be monitored closely. The doses of antidiabetic agents may require adjustment when NORDITROPIN is initiated. 5.5 Intracranial Hypertension Intracranial hypertension (IH) with papilledema, visual changes, headache, nausea, and/or vomiting has been reported in a small number of patients treated with somatropins. Symptoms usually occurred within the first eight (8) weeks after the initiation of somatropin therapy. In all reported cases, IH-associated signs and symptoms rapidly resolved after cessation of therapy or a reduction of the somatropin dose. Funduscopic examination should be performed routinely before initiating treatment with NORDITROPIN to exclude preexisting papilledema, and periodically thereafter. If papilledema is observed by funduscopy during somatropin treatment, treatment should be stopped. If somatropin-induced IH is diagnosed, treatment with NORDITROPIN can be restarted at a lower dose after IH-associated signs and symptoms have resolved. Patients with Turner syndrome may be at increased risk for the development of IH. 5.6 Severe Hypersensitivity Serious systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with postmarketing use of somatropins. Patients and caregivers should be informed that such reactions are possible and that prompt medical attention should be sought if an allergic reaction occurs [see Contraindications (4) ]. 5.7 Fluid Retention Fluid retention during somatropin replacement therapy in adults may frequently occur. Clinical manifestations of fluid retention (e.g. edema, arthralgia, myalgia, nerve compression syndromes including carpal tunnel syndrome/paraesthesias) are usually transient and dose dependent. 5.8 Hypoadrenalism Patients receiving somatropin therapy who have or are at risk for pituitary hormone deficiency(s) may be at risk for reduced serum cortisol levels and/or unmasking of central (secondary) hypoadrenalism. In addition, patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of NORDITROPIN treatment. Monitor patients for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism [see Drug Interactions (7) ]. 5.9 Hypothyroidism Undiagnosed/untreated hypothyroidism may prevent an optimal response to NORDITROPIN, in particular, the growth response in pediatric patients. Patients with Turner syndrome have an inherently increased risk of developing autoimmune thyroid disease and primary hypothyroidism. In patients with GH deficiency, central (secondary) hypothyroidism may first become evident or worsen during somatropin treatment. Therefore, patients should have periodic thyroid function tests and thyroid hormone replacement therapy should be initiated or appropriately adjusted when indicated. 5.10 Slipped Capital Femoral Epiphysis in Pediatric Patients Slipped capital femoral epiphysis may occur more frequently in patients with endocrine disorders (including GH deficiency and Turner syndrome) or in patients undergoing rapid growth. Slipped capital femoral epiphysis may lead to osteonecrosis. Cases of slipped capital femoral epiphysis with or without osteonecrosis have been reported in pediatric patients with short stature receiving somatropin, including NORDITROPIN. Evaluate pediatric patients receiving NORDITROPIN with the onset of a limp or complaints of hip or knee pain for slipped capital femoral epiphysis and osteonecrosis and manage accordingly . 5.11 Progression of Preexisting Scoliosis in Pediatric Patients Somatropin increases the growth rate, and progression of existing scoliosis can occur in patients who experience rapid growth. Somatropin has not been shown to increase the occurrence of scoliosis. Monitor patients with a history of scoliosis for progression of scoliosis. 5.12 Pancreatitis Cases of pancreatitis have been reported in pediatric patients and adults receiving somatropin products. There may be a greater risk in pediatric patients compared with adults. Published literature indicates that females who have Turner syndrome may be at greater risk than other pediatric patients receiving somatropin products. Pancreatitis should be considered in patients who develop persistent severe abdominal pain. 5.13 Lipoatrophy When somatropin products are administered subcutaneously at the same site over a long period of time, tissue atrophy may result. Rotate injection sites when administering NORDITROPIN to reduce this risk [see Administration and Use Instructions (2.1) ]. 5.14 Laboratory Tests Serum levels of inorganic phosphorus, alkaline phosphatase, parathyroid hormone (PTH) and IGF-I may increase after NORDITROPIN treatment."],"clinical_studies_table":["<table width=\"100%\"><col width=\"28%\"/><col width=\"8%\"/><col width=\"8%\"/><col width=\"8%\"/><col width=\"8%\"/><col width=\"8%\"/><col width=\"8%\"/><col width=\"8%\"/><col width=\"8%\"/><col width=\"8%\"/><tbody><tr><td styleCode=\"Rrule Lrule Toprule \" valign=\"top\"/><td align=\"center\" colspan=\"9\" styleCode=\"Rrule Lrule Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\">NORDITROPIN</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule \" valign=\"top\"/><td colspan=\"3\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">0.025 mg/kg/day</content></paragraph></td><td colspan=\"3\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">0.05 mg/kg/day</content></paragraph></td><td colspan=\"3\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">0.1 mg/kg/day</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"/><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">N</content></paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Mean</content></paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">SD</content></paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">N</content></paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Mean</content></paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">SD</content></paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">N</content></paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Mean</content></paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">SD</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Change in Standing Height (cm)</content></paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"/><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"/><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"/><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"/><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"/><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"/><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"/><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"/><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"/></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph> Baseline to Month 12</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>37</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>9.5</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>2.1</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>37</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>13.2*</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>2.6</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>34</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>13.7*</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>2.7</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph> Baseline to Month 24</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>34</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>17.6</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>3.4</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>37</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>22.2*</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>4.7</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>33</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>23.7*</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>4.0</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Change in Sitting Height (cm)</content></paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"/><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"/><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"/><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"/><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"/><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"/><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"/><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"/><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"/></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph> Baseline to Month 12</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>32</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>5.4</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>2.4</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>36</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>6.5*</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>1.6</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>32</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>7.4**</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>1.5</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph> Baseline to Month 24</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>29</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>9.3</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>2.5</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>35</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>10.8**</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>2.6</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>31</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>12.2**</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>2.0</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Change in Bone Age (yr)</content></paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"/><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"/><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"/><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"/><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"/><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"/><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"/><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"/><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"/></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph> Baseline to Month 12</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>37</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>1.3</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>0.9</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>38</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>1.7</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>0.8</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>34</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>1.6</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>0.8</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph> Month 12 to Month 24</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>37</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>0.6</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>2.5</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>38</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>1.4</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>2.7</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>34</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>1.6*</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>0.8</paragraph></td></tr></tbody></table>","<table width=\"100%\"><col width=\"33%\"/><col width=\"17%\"/><col width=\"17%\"/><col width=\"17%\"/><col width=\"17%\"/><tbody><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"/><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">Dose A</content></paragraph><paragraph><content styleCode=\"bold\">0.045 mg/kg/day</content></paragraph><paragraph><content styleCode=\"bold\">(n = 19)</content></paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">Dose B</content></paragraph><paragraph><content styleCode=\"bold\">up to 0.067 mg/kg/day</content></paragraph><paragraph><content styleCode=\"bold\">(n = 15)</content></paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">Dose C</content></paragraph><paragraph><content styleCode=\"bold\">up to 0.089 mg/kg/day</content></paragraph><paragraph><content styleCode=\"bold\">(n = 12)</content></paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">Total</content></paragraph><paragraph><content styleCode=\"bold\">(n = 46)</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Baseline height (cm)<sup>1</sup></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>105 (12)</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>108 (12.7)</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>107 (11.7)</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>106 (11.9)</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Final height (cm)<sup>1</sup></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>157 (6.7)</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>163 (6.0)</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>163 (4.9)</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>161 (6.5)</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Number (%) of patients reaching normal height (height SDS &gt;-2 using National standard)</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>10 (53%)</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>12 (80%)</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>10 (83%)</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>32 (70%)</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Height SDS (Turner standard)<sup>2</sup></paragraph></td><td colspan=\"4\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"/></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Final [95% CI]</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>1.7 [1.4, 2.0]</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>2.5 [2.1, 2.8]<sup>3</sup></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>2.5 [2.1, 2.9]<sup>4</sup></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>NA</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Change from baseline [95% CI]</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>1.5 [1.2, 1.8]</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>2.2 [1.9, 2.5]<sup>3</sup></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>2.2 [1.9, 2.6]<sup>4</sup></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>NA</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Height SDS (National standard)<sup>2</sup></paragraph></td><td colspan=\"4\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"/></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Final [95% CI]</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>-1.9 [-2.2, -1.6]</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>-1.2 [-1.5, -0.9]<sup>4</sup></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>-1.2 [-1.6, -0.8]<sup>5</sup></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>NA</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>Change from baseline [95% CI]</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>0.7 [0.4, 1.0]</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>1.4 [1.1, 1.7]<sup>4</sup></paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>1.4 [1.1, 1.8]<sup>5</sup></paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>NA</paragraph></td></tr></tbody></table>","<table width=\"100%\"><col width=\"30%\"/><col width=\"30%\"/><col width=\"20%\"/><col width=\"20%\"/><tbody><tr><td rowspan=\"2\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"/><td align=\"center\" colspan=\"3\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">Raw Mean &#xB1; SD (N)</content></paragraph></td></tr><tr><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>Dose A</paragraph><paragraph>0.033 mg/kg/day</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>Dose B</paragraph><paragraph>0.067 mg/kg/day</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>Total</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Baseline Height SDS </paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>-3.2 &#xB1; 0.7 (26)</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>-3.2 &#xB1; 0.7 (27)</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>-3.2 &#xB1; 0.7 (53)</paragraph></td></tr><tr><td colspan=\"4\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Adjusted least-squares mean &#xB1; standard error (N), Treatment Difference [95% confidence intervals]</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Height SDS: Change from Baseline at Year 2<sup>2</sup></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>1.4 &#xB1; 0.1 (26)</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>1.8 &#xB1; 0.1 (26)</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>Treatment Diff = 0.4</paragraph><paragraph>[0.2, 0.7]<sup>3</sup></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Height SDS: Change from Baseline at Final Height<sup>1</sup></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>1.4 &#xB1; 0.2 (19)</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>1.8 &#xB1; 0.2 (19)</paragraph></td><td align=\"center\" rowspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>Treatment Diff = 0.5</paragraph><paragraph>[0.0, 0.9]<sup>3</sup></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Final Height SDS<sup>1</sup></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>-1.8 &#xB1; 0.2 (19)</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>-1.3 &#xB1; 0.2 (19)</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>Final Height SDS &gt; -2</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule \" valign=\"middle\"><paragraph>13/19 (68%)</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule \" valign=\"middle\"><paragraph>11/19 (58%)</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule \" valign=\"middle\"><paragraph>24/38 (63%)</paragraph></td></tr></tbody></table>","<table width=\"100%\"><col width=\"27%\"/><col width=\"27%\"/><col width=\"23%\"/><col width=\"23%\"/><tbody><tr><td rowspan=\"2\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"/><td align=\"center\" colspan=\"3\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">Raw Mean &#xB1; SD (N)</content></paragraph></td></tr><tr><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>No Treatment</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>0.033 mg/kg/day</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>0.067 mg/kg/day</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>Height SDS: Baseline</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>-2.9 &#xB1; 0.5 (15)</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>-3.0 &#xB1; 0.6 (35)</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>-2.9 &#xB1; 0.7 (34)</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>Height SDS: Year 1</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>-2.8 &#xB1; 0.5 (15)</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>-2.4 &#xB1; 0.6 (33)</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>-2.0 &#xB1; 0.8 (34)</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>Height SDS: Year 2</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>NA</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>-2.2 &#xB1; 0.7 (33)</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>-1.4 &#xB1; 0.7 (32)</paragraph></td></tr><tr><td align=\"center\" colspan=\"4\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">Adjusted least-squares mean &#xB1; standard error (N), Treatment Diff</content></paragraph><paragraph><content styleCode=\"bold\">[95% confidence intervals]</content></paragraph></td></tr><tr><td rowspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>Height SDS: Change from Baseline at Year 1<sup>1</sup></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>0.1 &#xB1; 0.1 (15)</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>0.6 &#xB1; 0.1 (33)</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>0.9 &#xB1; 0.1 (34)</paragraph></td></tr><tr><td colspan=\"3\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>0.033 vs. No Treatment: Treatment Diff = 0.5, [0.3, 0.7]<sup>2</sup></paragraph><paragraph>0.067 vs. No Treatment: Treatment Diff = 0.8, [0.6, 1.0]<sup>2</sup></paragraph><paragraph>0.067 vs. 0.033: Treatment Diff = 0.3, [0.2, 0.5]<sup>2</sup></paragraph></td></tr><tr><td rowspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>Height SDS: Change from Baseline at Year 2<sup>1</sup></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>NA</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>0.8 &#xB1; 0.1 (33)</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>1.4 &#xB1; 0.1 (32)</paragraph></td></tr><tr><td colspan=\"3\" styleCode=\"Rrule Botrule Lrule \" valign=\"middle\"><paragraph>0.067 vs. 0.033: Treatment Diff = 0.6, [0.5, 0.8], p-value &lt; 0.0001</paragraph></td></tr></tbody></table>","<table width=\"100%\"><col width=\"20%\"/><col width=\"16%\"/><col width=\"16%\"/><col width=\"16%\"/><col width=\"16%\"/><col width=\"16%\"/><tbody><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"/><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"/><td align=\"center\" colspan=\"4\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">Another Somatropin Product</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"/><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">Untreated</content></paragraph><paragraph><content styleCode=\"bold\">(n=30)</content></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">0.033 mg/kg/day</content></paragraph><paragraph><content styleCode=\"bold\">(n=30)</content></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">0.067 mg/kg/day</content></paragraph><paragraph><content styleCode=\"bold\">(n=42)</content></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">0.033 vs Untreated</content></paragraph><paragraph><content styleCode=\"bold\">(95% CI)</content></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">0.067 vs Untreated</content></paragraph><paragraph><content styleCode=\"bold\">(95% CI)</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Baseline height SDS </paragraph><paragraph>Final height SDS minus baseline </paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>0.41 (0.58)</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>0.95 (0.75)</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>1.36 (0.64)</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>+0.53 (0.20, 0.87)**</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>+0.94 (0.63, 1.26)**</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>Baseline predicted ht</paragraph><paragraph>Final height SDS minus baseline predicted final height SDS</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule \" valign=\"middle\"><paragraph>0.23 (0.66)</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule \" valign=\"middle\"><paragraph>0.73 (0.63)</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule \" valign=\"middle\"><paragraph>1.05 (0.83)</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule \" valign=\"middle\"><paragraph>+0.60 (0.09, 1.11)**</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule \" valign=\"middle\"><paragraph>+0.90 (0.42, 1.39)**</paragraph></td></tr></tbody></table>","<table ID=\"_RefID0EOGBI\" width=\"100%\"><caption>Table 9 &#x2013; Efficacy of Another Somatropin Product in Pediatric Patients with Prader-Willi Syndrome (Mean &#xB1; SD)</caption><col width=\"28%\"/><col width=\"17%\"/><col width=\"18%\"/><col width=\"18%\"/><col width=\"18%\"/><tbody><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"/><td align=\"center\" colspan=\"2\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">Study 1</content></paragraph></td><td align=\"center\" colspan=\"2\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">Study 2</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"/><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">Another Somatropin Product (0.24 mg/kg/week)</content></paragraph><paragraph><content styleCode=\"bold\">(n=15)</content></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">Untreated Control (n=12)</content></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">Another Somatropin Product (0.36 mg/kg/week)</content></paragraph><paragraph><content styleCode=\"bold\">(n=7)</content></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">Untreated Control </content></paragraph><paragraph><content styleCode=\"bold\">(n=9)</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">Linear growth (cm)</content></paragraph><paragraph>Baseline height</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>112.7 &#xB1; 14.9</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>109.5 &#xB1; 12.0</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>120.3 &#xB1; 17.5</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>120.5 &#xB1; 11.2</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>Growth from 0 to 12 months</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>11.6* &#xB1; 2.3</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>5.0 &#xB1; 1.2</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>10.7* &#xB1; 2.3</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>4.3 &#xB1; 1.5</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>Baseline SDS</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>-1.6 &#xB1; 1.3</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>-1.8 &#xB1; 1.5</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>-2.6 &#xB1; 1.7</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>-2.1 &#xB1; 1.4</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule Lrule \" valign=\"middle\"><paragraph>SDS at 12 months</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule \" valign=\"middle\"><paragraph>-0.5* &#xB1; 1.3</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule \" valign=\"middle\"><paragraph>-1.9 &#xB1; 1.4</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule \" valign=\"middle\"><paragraph>-1.4* &#xB1; 1.5</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule \" valign=\"middle\"><paragraph>-2.2 &#xB1; 1.4</paragraph></td></tr></tbody></table>","<table width=\"100%\"><col width=\"51%\"/><col width=\"25%\"/><col width=\"25%\"/><tbody><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"/><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"><paragraph>NORDITROPIN</paragraph><paragraph>(n=15)</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"><paragraph>Placebo</paragraph><paragraph>(n=16)</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Baseline (mean)</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>50.27</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>51.72</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Change from baseline at 6 months (mean)</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>1.12</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>-0.63</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>Treatment difference (mean) </paragraph><paragraph>95% confidence interval</paragraph><paragraph>p-value </paragraph></td><td align=\"center\" colspan=\"2\" styleCode=\"Rrule Botrule Lrule \" valign=\"middle\"><paragraph>1.74</paragraph><paragraph>(0.65, 2.83)</paragraph><paragraph>p=0.0028*</paragraph></td></tr></tbody></table>","<table width=\"100%\"><col width=\"49%\"/><col width=\"27%\"/><col width=\"24%\"/><tbody><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"/><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>NORDITROPIN</paragraph><paragraph>(n=15)</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>Placebo</paragraph><paragraph>(n=16)</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Baseline (mean)</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>44.74</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>42.26</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Change from baseline at 6 months (mean)</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>-2.83</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>1.92</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>Treatment difference (mean) </paragraph><paragraph>95% confidence interval</paragraph><paragraph>p-value </paragraph></td><td align=\"center\" colspan=\"2\" styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>-4.74</paragraph><paragraph>(-7.18, -2.30)</paragraph><paragraph>p=0.0004*</paragraph></td></tr></tbody></table>","<table width=\"100%\"><col width=\"51%\"/><col width=\"25%\"/><col width=\"25%\"/><tbody><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"/><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>NORDITROPIN</paragraph><paragraph>(n=36)</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>Placebo</paragraph><paragraph>(n=13)</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Baseline (mean)</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>48.18</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>48.90</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Change from baseline at 6 months (mean)</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>2.06</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>0.70</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>Treatment difference (mean) </paragraph><paragraph>95% confidence interval</paragraph><paragraph>p-value </paragraph></td><td align=\"center\" colspan=\"2\" styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>1.40</paragraph><paragraph>(0.39, 2.41)</paragraph><paragraph>p=0.0079*</paragraph></td></tr></tbody></table>","<table width=\"100%\"><col width=\"49%\"/><col width=\"27%\"/><col width=\"24%\"/><tbody><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"/><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>NORDITROPIN</paragraph><paragraph>(n=36)</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>Placebo</paragraph><paragraph>(n=13)</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Baseline (mean)</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>34.55</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>34.07</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Change from baseline at 6 months (mean)</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>-6.00</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>-1.78</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>Treatment difference (mean) </paragraph><paragraph>95% confidence interval</paragraph><paragraph>p-value </paragraph></td><td align=\"center\" colspan=\"2\" styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>-4.24</paragraph><paragraph>(-7.11, -1.37)</paragraph><paragraph>p=0.0048*</paragraph></td></tr></tbody></table>"],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity and mutagenicity studies have not been conducted with NORDITROPIN. In a rat study evaluating female fertility, animals were administered once daily subcutaneous doses of 0.1, 0.3, and 1.1 mg/kg NORDITROPIN beginning two weeks prior to mating, throughout mating and during the first 7 days of pregnancy. Delays in the time to mating were observed at doses greater than or equal to 0.3 mg/kg (approximately 3 times the maximum adult clinical dose of 0.016 mg/kg, based on body surface area), but these doses were also associated with increases in the number of corpora lutea and implantations. A decrease in the pregnancy rate was observed at the dose of 1.1 mg/kg (approximately 10 times the clinical dose of 0.016 mg/kg, based on body surface area). Male fertility parameters have not been evaluated with administration of NORDITROPIN."],"adverse_reactions_table":["<table width=\"100%\"><col width=\"45%\"/><col width=\"28%\"/><col width=\"28%\"/><tbody><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"/><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>Placebo</paragraph><paragraph>(N=52)</paragraph></td><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>NORDITROPIN</paragraph><paragraph>(N=53)</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Adverse Reactions</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>%</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>%</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Peripheral Edema</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>8</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>42</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Edema</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>0</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>25</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Arthralgia</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>15</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>19</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Leg Edema</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>4</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>15</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Myalgia</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>8</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>15</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Infection (non-viral) </paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>8</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>13</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Paraesthesia</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>6</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>11</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Skeletal Pain</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>2</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>11</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Headache</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>6</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>9</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Bronchitis</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>0</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>9</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Flu-like symptoms</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>4</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>8</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Hypertension</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>2</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>8</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Gastroenteritis</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>8</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>8</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Other Non-Classifiable Disorders (excludes accidental injury)</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>6</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>8</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Increased sweating</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>2</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>8</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Glucose tolerance abnormal</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>2</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>6</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Laryngitis</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>6</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>6</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>Type 2 diabetes mellitus </paragraph></td><td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>0</paragraph></td><td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>5</paragraph></td></tr></tbody></table>"],"drug_interactions_table":["<table width=\"100%\"><col width=\"21%\"/><col width=\"79%\"/><tbody><tr><td colspan=\"2\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">Glucocorticoids </content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph><content styleCode=\"italics\">Clinical Impact:</content></paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>Microsomal enzyme 11&#x3B2;-hydroxysteroid dehydrogenase type 1 (11&#x3B2;HSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. NORDITROPIN inhibits 11&#x3B2;HSD-1. Consequently, individuals with untreated GH deficiency have relative increases in 11&#x3B2;HSD-1 and serum cortisol. Initiation of NORDITROPIN may result in inhibition of 11&#x3B2;HSD-1 and reduced serum cortisol concentrations. </paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph><content styleCode=\"italics\">Intervention:</content></paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>Patients treated with glucocorticoid replacement for hypoadrenalism may require an increase in their maintenance or stress doses following initiation of NORDITROPIN <content styleCode=\"italics\">[see <linkHtml href=\"#ID_57e07a9a-d800-460f-b615-9c61b960a884\">Warnings and Precautions (5.8)</linkHtml>].</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph><content styleCode=\"italics\">Examples:</content></paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>Cortisone acetate and prednisone may be effected more than others since conversion of these drugs to their biologically active metabolites is dependent on the activity of 11&#x3B2;HSD-1.</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">Pharmacologic Glucocorticoid Therapy and Supraphysiologic Glucocorticoid Treatment</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph><content styleCode=\"italics\">Clinical Impact:</content></paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>Pharmacologic glucocorticoid therapy and supraphysiologic glucocorticoid treatment may attenuate the growth promoting effects of NORDITROPIN in pediatric patients.</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph><content styleCode=\"italics\">Intervention:</content></paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>Carefully adjust glucocorticoid replacement dosing in pediatric patients receiving glucocorticoid treatments to avoid both hypoadrenalism and an inhibitory effect on growth.</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">Cytochrome P450-Metabolized Drugs</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph><content styleCode=\"italics\">Clinical Impact:</content></paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>Limited published data indicate that somatropin treatment increases cytochrome P450 (CP450)-mediated antipyrine clearance. NORDITROPIN may alter the clearance of compounds known to be metabolized by CP450 liver enzymes.</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph><content styleCode=\"italics\">Intervention:</content></paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>Careful monitoring is advisable when NORDITROPIN is administered in combination with drugs metabolized by CP450 liver enzymes.</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">Oral Estrogen</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph><content styleCode=\"italics\">Clinical Impact:</content></paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>Oral estrogens may reduce the serum IGF-1 response to NORDITROPIN. </paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph><content styleCode=\"italics\">Intervention:</content></paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>Patients receiving oral estrogen replacement may require greater NORDITROPIN dosages <content styleCode=\"italics\">[see <linkHtml href=\"#i4i_section_id_c0a91673-bf31-4219-beb5-d42d3641bc31\">Dosage and Administration (2.3)</linkHtml>]</content>.</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">Insulin and/or Other Hypoglycemic Agents</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph><content styleCode=\"italics\">Clinical Impact:</content></paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>Treatment with NORDITROPIN may decrease insulin sensitivity, particularly at higher doses. </paragraph></td></tr><tr><td styleCode=\"Rrule Botrule Lrule \" valign=\"middle\"><paragraph><content styleCode=\"italics\">Intervention:</content></paragraph></td><td styleCode=\"Rrule Botrule Lrule \" valign=\"middle\"><paragraph>Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other hypoglycemic agents <content styleCode=\"italics\">[see <linkHtml href=\"#i4i_section_id_160d3380-8e15-4125-8147-387e730c3351\">Warnings and Precautions (5.4)</linkHtml>].</content></paragraph></td></tr></tbody></table>"],"information_for_patients":["17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). • Neoplasms – Advise childhood cancer survivors/caregivers that individuals treated with brain/head radiation are at increased risk of secondary neoplasms and as a precaution need to be monitored for recurrence. Advise patients/caregivers to report marked changes in behavior, onset of headaches, vision disturbances and/or changes in skin pigmentation or changes in the appearance of pre-existing nevi. • Fluid Retention - Advise patients that fluid retention during NORDITROPIN replacement therapy in adults may frequently occur. Inform patients of the clinical manifestations of fluid retention (e.g. edema, arthralgia, myalgia, nerve compression syndromes including carpal tunnel syndrome/paraesthesias) and to report to their healthcare provider any of these signs or symptoms occur during treatment with NORDITROPIN . • Pancreatitis - Advise patients/caregivers that pancreatitis may develop and to report to their healthcare provider any new onset abdominal pain. • Hypoadrenalism - Advise patients/caregivers who have or who are at risk for pituitary hormone deficiency(s) that hypoadrenalism may develop and to report to their healthcare provider if they experience hyperpigmentation, extreme fatigue, dizziness, weakness, or weight loss. • Hypothyroidism - Advise patients/caregivers that undiagnosed/untreated hypothyroidism may prevent an optimal response to NORDITROPIN. Advise patients/caregivers they may require periodic thyroid function tests. • Intracranial Hypertension - Advise patients/caregivers to report to their healthcare provider any visual changes, headache, and nausea and/or vomiting. • Hypersensitivity Reactions – Advise patients/caregivers that serious systemic hypersensitivity reactions (anaphylaxis and angioedema) are possible and that prompt medical attention should be sought if an allergic reaction occurs. • Glucose Intolerance/ Diabetes Mellitus – Advise patients/caregivers that new onset impaired glucose intolerance/diabetes mellitus or exacerbation of preexisting diabetes mellitus can occur and monitoring of blood glucose during treatment with NORDITROPIN may be needed. NORDITROPIN ® and FlexPro ® are registered trademarks of Novo Nordisk Health Care AG . Novo Nordisk is a registered trademark of Novo Nordisk A/S . PATENT Information: http://novonordisk-us.com/products/product-patents.html Manufactured by: Novo Nordisk Inc. 800 Scudders Mill Road Plainsboro, NJ 08536 USA U.S. License No. 1261 For information about NORDITROPIN call: 1 (888) 668-6444 © 2025 Novo Nordisk A/S"],"dosage_and_administration":["2 DOSAGE AND ADMINISTRATION • Administer by subcutaneous injection to the back of upper arm, abdomen, buttock, or thigh with regular rotation of injection sites ( 2.1 ) • Pediatric Dosage - divide the calculated weekly dosage into equal doses given either 6, or 7 days per week o GHD: 0.17 mg/kg/week to 0.24 mg/kg/week( 2.2 ) o Noonan Syndrome: Up to 0.46 mg/kg/week ( 2.2 ) o Turner Syndrome: Up to 0.47 mg/kg/week ( 2.2 ) o SGA: Up to 0.47 mg/kg/week ( 2.2 ) o ISS: Up to 0.47 mg/kg/week ( 2.2 ) o Prader-Willi Syndrome: 0.24 mg/kg/week ( 2.2 ) o Adult Dosage: Either of the following two dosing regimens may be used: o Non-weight based dosing: Initiate with a dose of approximately 0.2 mg/day (range, 0.15 mg/day-0.3 mg/day) and increase the dose every 1-2 months by increments of approximately 0.1 mg/day-0.2 mg/day, according to individual patient requirements ( 2.3 ) o Weight-based dosing (Not recommended for obese patients): Initiate at 0.004 mg/kg daily and increase the dose according to individual patient requirements to a maximum of 0.016 mg/kg daily ( 2.3 ) 2.1 Administration and Use Instructions • Therapy with NORDITROPIN should be supervised by a physician who is experienced in the diagnosis and management of patients with the conditions for which NORDITROPIN is indicated [see Indications and Usage (1) ]. • Fundoscopic examination should be performed routinely before initiating treatment with NORDITROPIN to exclude preexisting papilledema, and periodically thereafter [see Warnings and Precautions (5.5) ]. • Administer NORDITROPIN by subcutaneous injection to the back of the upper arm, abdomen, buttocks, or thigh with regular rotation of injection sites to avoid lipoatrophy. • Inspect visually for particulate matter and discoloration. NORDITROPIN should be clear and colorless. If the solution is cloudy or contains particulate matter do not use. • Instructions for delivering the dosage are provided in the PATIENT INFORMATION and INSTRUCTIONS FOR USE leaflets enclosed with the NORDITROPIN FlexPro prefilled pen. 2.2 Pediatric Dosage • Individualize dosage for each patient based on the growth response. • Divide the calculated weekly NORDITROPIN dosage into equal doses given either 6, or 7 days per week. • The recommended weekly dose in milligrams (mg) per kilogram (kg) of body weight for pediatric patients is: o Pediatric GH Deficiency: 0.17 mg/kg/week to 0.24 mg/kg/week (0.024 to 0.034 mg/kg/day) o Noonan Syndrome: Up to 0.46 mg/kg/week (up to 0.066 mg/kg/day) o Turner Syndrome: Up to 0.47 mg/kg/week (up to 0.067 mg/kg/day) o Small for Gestational Age (SGA): Up to 0.47 mg/kg/week (up to 0.067 mg/kg/day) • In very short pediatric patients, HSDS less than -3, and older pubertal pediatric patients consider initiating treatment with a larger dose of NORDITROPIN (up to 0.067 mg/kg/day). Consider a gradual reduction in dosage if substantial catch-up growth is observed during the first few years of therapy. In pediatric patients less than 4 years of age with less severe short stature, baseline HSDS values between -2 and -3, consider initiating treatment at 0.033 mg/kg/day and titrate the dose as needed. o Idiopathic Short Stature: Up to 0.47 mg/kg/week (up to 0.067 mg/kg/day) o Prader-Willi Syndrome: 0.24 mg/kg/week (0.034 mg/kg/day) • Assess compliance and evaluate other causes of poor growth such as hypothyroidism, under-nutrition, advanced bone age and antibodies to recombinant human growth hormone if patients experience failure to increase height velocity, particularly during the first year of treatment. • Discontinue NORDITROPIN for stimulation of linear growth once epiphyseal fusion has occurred [see Contraindications (4) ]. 2.3 Adult Dosage • Patients who were treated with somatropin for GH deficiency in childhood and whose epiphyses are closed should be reevaluated before continuation of somatropin for GH deficient adults. • Consider using a lower starting dose and smaller dose increment increases for geriatric patients as they may be at increased risk for adverse reactions with NORDITROPIN than younger individuals [see Use in Specific Populations (8.5) ]. • Estrogen-replete women and patients receiving oral estrogen may require higher doses [see Drug Interactions (7) ]. • Administer the prescribed dose daily. • Either of two NORDITROPIN dosing regimens may be used: o Non-weight based • Initiate NORDITROPIN with a dose of approximately 0.2 mg/day (range, 0.15 mg/day to 0.3 mg/day) and increase the dose every 1-2 months by increments of approximately 0.1 mg/day to 0.2 mg/day, according to individual patient requirements based on the clinical response and serum insulin-like growth factor 1 (IGF-1) concentrations. • Decrease the dose as necessary on the basis of adverse reactions and/or serum IGF-1 concentrations above the age- and gender-specific normal range. • Maintenance dosages will vary considerably from person to person, and between male and female patients. o Weight-based • Initiate NORDITROPIN at 0.004 mg/kg daily and increase the dose according to individual patient requirements to a maximum of 0.016 mg/kg daily. • Use the patient’s clinical response, adverse reactions, and determination of age- and gender-adjusted serum IGF-1 concentrations as guidance in dose titration. • Not recommended for obese patients as they are more likely to experience adverse reactions with this regimen"],"spl_product_data_elements":["Norditropin somatropin SOMATROPIN SOMATROPIN HISTIDINE HYDROCHLORIC ACID MANNITOL PHENOL POLOXAMER 188 SODIUM HYDROXIDE WATER Norditropin somatropin SOMATROPIN SOMATROPIN HISTIDINE HYDROCHLORIC ACID MANNITOL PHENOL POLOXAMER 188 SODIUM HYDROXIDE WATER Norditropin somatropin SOMATROPIN SOMATROPIN HISTIDINE HYDROCHLORIC ACID MANNITOL PHENOL POLOXAMER 188 SODIUM HYDROXIDE WATER Norditropin somatropin SOMATROPIN SOMATROPIN HISTIDINE POLOXAMER 188 PHENOL MANNITOL WATER SODIUM HYDROXIDE HYDROCHLORIC ACID"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS Injection: NORDITROPIN is available as a clear and colorless solution in a • 5 mg/1.5 mL FlexPro single-patient-use pen (orange) • 10 mg/1.5 mL FlexPro single-patient-use pen (blue) • 15 mg/1.5 mL FlexPro single-patient-use pen (green) • 30 mg/3 mL FlexPro single-patient-use pen (purple) Injection: • 5 mg/1.5 mL: FlexPro single-patient-use pen ( 3 ) • 10 mg/1.5 mL: FlexPro single-patient-use pen ( 3 ) • 15 mg/1.5 mL: FlexPro single-patient-use pen ( 3 ) • 30 mg/3 mL: FlexPro single-patient-use pen ( 3 )"],"instructions_for_use_table":["<table width=\"100%\"><col width=\"50%\"/><col width=\"50%\"/><tbody><tr><td align=\"center\" colspan=\"2\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><renderMultiMedia ID=\"id-155538904\" referencedObject=\"ID_8437c9f9-16c1-4b1e-9cac-976444b5859b\"/></td></tr><tr><td align=\"center\" colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id746619391\" referencedObject=\"ID_6377131c-3869-4f24-8011-dc9f0cc105b6\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Norditropin FlexPro Pen is for single-patient-use only.</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Supplies you will need:</content></paragraph><list listType=\"unordered\"><item><caption>&#x2022;</caption>Norditropin FlexPro prefilled Pen  new injection needle. Norditropin prefilled Pen is designed to be used with all Novo Nordisk disposable needles up to a length of 8 mm</item><item><caption>&#x2022;</caption>sharps disposal container. See step 5 for information on how to throw away (dispose of) used needles and Pens.</item><item><caption>&#x2022;</caption>alcohol pad</item><item><caption>&#x2022;</caption>gauze pad</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id2040159561\" referencedObject=\"D0AAF207-197E-4FD8-882C-80EE9882EC14\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">How to use your Norditropin FlexPro Pen</content></paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">5 steps you should follow for a Norditropin injection:</content></paragraph><list listType=\"unordered\"><item><caption> </caption>Step 1: Prepare your Norditropin FlexPro Pen </item><item><caption> </caption>Step 2: Check the Norditropin flow with each new Pen </item><item><caption> </caption>Step 3: Select your dose</item><item><caption> </caption>Step 4: Inject your dose</item><item><caption> </caption>Step 5: After your injection</item></list><paragraph><content styleCode=\"bold\">For further information about your Pen see:</content></paragraph><list listType=\"unordered\"><item><caption> </caption>Frequently Asked Questions</item><item><caption> </caption>Important information</item><item><caption> </caption>Patient Information</item><item><caption> </caption><content styleCode=\"bold\">&#xA71D;Important information</content></item><item><caption> </caption>Make sure that you read this information carefully.</item><item><caption> </caption><content styleCode=\"bold\">&#xA71F;Additional information</content></item></list></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Norditropin is for use under the skin only (subcutaneous).</content></paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Do not</content> share your Norditropin Pen and needles with another person. You may give another person an infection or get an infection from them. </paragraph><paragraph><content styleCode=\"bold\">Do not use your Pen without proper training from your healthcare provider</content>. </paragraph><paragraph>Make sure that you are confident in giving an injection with the Pen before you start your treatment.</paragraph><paragraph>If you are blind or have poor eyesight and cannot read the dose counter on the Pen, do not use this Pen without help. Get help from a person with good eyesight who is trained to use the Pen.</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Step 1. Prepare your Norditropin FlexPro Pen</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Wash your hands with soap and water. </item><item><caption> </caption><list listType=\"ordered\"><item><caption>&#x2022;</caption><content styleCode=\"bold\">Check the name, strength, and colored label </content>on your Pen to make sure that it contains Norditropin in the right strength. </item></list></item><item><caption> </caption><list listType=\"ordered\"><item><caption>&#x2022;</caption>Pull off the Pen cap. </item></list></item><item><caption> </caption><list listType=\"ordered\"><item><caption>&#x2022;</caption>Turn the Pen upside down 1 or 2 times to check that the Norditropin in your Pen is clear and colorless.</item></list></item><item><caption> </caption>See figure A. <content styleCode=\"bold\">If the Norditropin looks cloudy, do not use the Pen.</content></item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id204454492\" referencedObject=\"CE840678-12D1-477F-9781-09B95C301102\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption> When you are ready to give your injection, take a new disposable needle, and remove the paper tab. </item><item><caption>&#x2022;</caption>Push the needle straight onto the Pen. Turn the needle clockwise <content styleCode=\"bold\">until it is on tight</content>. See figure B.</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-930046935\" referencedObject=\"ID_4c267772-c403-4bf6-993a-84e90841c0e4\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">&#xA71D;Always use a new needle for each injection.</content> This reduces the risk of contamination, infection, leakage of Norditropin, and blocked needles leading to incorrect dosing.</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Pull off the outer needle cap and <content styleCode=\"bold\">dispose of it</content>. See figure C.</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id1129979604\" referencedObject=\"DF1D6196-4EA7-44F4-92EA-5FFA5A208B1C\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Pull off the inner needle cap and dispose of it. See figure D.</item><item><caption> </caption>&#xA71F;A drop of Norditropin may appear at the needle tip. This is normal, but you must still check the Norditropin flow with each new Pen. See step 2.</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id77788548\" referencedObject=\"ID_9f4f7430-a4fc-4b9e-8775-2c3507a24ca5\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption> </caption><content styleCode=\"bold\">&#xA71D;Never use a bent or damaged needle.</content></item></list></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Step 2. Check the Norditropin flow with each new Pen</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"/><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"/></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>&#xA71F;<content styleCode=\"bold\">If your Pen is already in use</content>, go to step 3.</paragraph><list listType=\"unordered\"><item><caption> </caption><content styleCode=\"bold\">Before using a new Pen</content>, check the Norditropin flow to make sure the growth hormone can flow through the Pen and needle.</item></list><list listType=\"ordered\"><item><caption>1.</caption>Turn the dose selector clockwise 1 tick marking on the dose counter to select 0.025 mg. You will hear a faint &#x201C;click&#x201D; when you turn the dose selector. See figure E.</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id1123817563\" referencedObject=\"F9AA0AAB-5C05-40AA-AF3F-B19434F1A4F4\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption><content styleCode=\"bold\">1 marking on the dose counter equals 0.025 mg</content>. See figure F.</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-1412074451\" referencedObject=\"D3190D7F-A9A0-42C6-A3EE-018006FB4DCE\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Hold the Pen with the needle pointing up. Press and hold in the dose button until the dose counter returns to &#x201C;0&#x201D;. <content styleCode=\"bold\">The &#x201C;0&#x201D; must line up with the dose pointer</content>. See figure G.</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id766659825\" referencedObject=\"A109CEFA-ACAC-4520-8114-C1E040FA3E19\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Check that a drop of Norditropin appears at the needle tip. See figure H.</item></list><paragraph><content styleCode=\"bold\">&#xA71D;If no Norditropin appears</content>, repeat step 2 up to 6 times.</paragraph><list listType=\"unordered\"><item><caption> </caption>If you still do not see a drop of Norditropin, <content styleCode=\"bold\">change the needle:</content></item></list><list listType=\"ordered\"><item><caption>1.</caption>Carefully remove the needle from the Pen by turning the needle counterclockwise. Place the needle in a sharps disposal container immediately. See step 5.</item><item><caption>2.</caption>and repeat step 2 again.</item><item><caption> </caption><content styleCode=\"bold\">Do not use the Pen if a drop of Norditropin still does not appear after changing the needle and repeating step 2. Call Novo Nordisk at </content></item><item><caption> </caption><content styleCode=\"bold\">1-888-668-6444 for help.</content></item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id378594839\" referencedObject=\"AA8E9E7B-87E4-4BEB-A749-7779B5BC0A39\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Step 3. Select your dose</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>To start, check that the dose pointer is set at <content styleCode=\"bold\">&#x201C;0&#x201D;.</content></item><item><caption>&#x2022;</caption>&#x2022; Turn the dose selector clockwise to select the dose you need. See figure I.</item><item><caption> </caption>When you have selected your dose, you can go to step 4.</item></list><paragraph>&#xA71F;<content styleCode=\"bold\">If there is not enough Norditropin left </content>to select a full dose, see <content styleCode=\"bold\">Frequently Asked Questions</content><content styleCode=\"italics\">.</content></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id1557972136\" referencedObject=\"BF5DE29E-EEBE-4ADD-B697-D1E24FF1FB4D\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>&#xA71F;The dose counter shows the dose in &#x201C;mg&#x201C;. See figures J and K. Always use the dose counter to select the exact dose<content styleCode=\"bold\">. Do not use the &#x201C;click&#x201C; sounds you hear when you turn the dose selector or the Pen scale to select your dose. Only the dose pointer on the dose counter will show the exact dose selected. </content></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-923565870\" referencedObject=\"ID_438acbf0-5166-4e4d-84de-29a538b4e437\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"/><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-1078438641\" referencedObject=\"ID_5bab6ab7-fe0c-4cd4-9eae-cc278d311efe\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>&#xA71F;If you select the wrong dose, you can turn the dose selector clockwise or counterclockwise to the correct dose. See figure L.</paragraph><list listType=\"unordered\"><item><caption> </caption>The Pen &#x201C;clicks&#x201D; sound and feel differently when the dose selector is turned clockwise, counterclockwise, or if you forcefully move it past the number of &#x201C;mg&#x201D; left in the Pen.</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id1816074406\" referencedObject=\"ID_3d8e9e52-6d28-4f3b-865d-07ab66660780\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Step 4. Inject your dose</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Select the injection site.</item><item><caption>&#x2022;</caption>Norditropin can be injected under the skin (subcutaneously) of your stomach area (abdomen), buttocks, upper legs (thighs), or upper arms, as instructed by your healthcare provider. Change the injection site every day. </item><item><caption>&#x2022;</caption>Wipe the injection site with an alcohol swab and let the area dry.</item><item><caption>&#x2022;</caption>Insert the needle into your skin as your healthcare provider has shown you. See figure M. </item><item><caption> </caption>Make sure you can see the dose counter. <content styleCode=\"bold\">Do not cover it with your fingers</content>. This could block the injection.</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-746179374\" referencedObject=\"ID_5a017587-8804-428d-a761-adc8d3e5256e\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Press and hold down the dose button until the dose counter shows &#x201C;0&#x201D;. See figure N. <content styleCode=\"bold\">The &#x201C;0&#x201D; must line up with the dose pointer</content>. You may then hear or feel a &#x201C;click&#x201D;. </item><item><caption>&#x2022;</caption><content styleCode=\"bold\">Continue to hold the needle in your skin. </content></item></list><paragraph>&#xA71F;If &#x201C;0&#x201D; does not appear in the dose counter after continuously pressing the dose button, your needle may be blocked or damaged, see <content styleCode=\"bold\">Frequently Asked Questions</content>.</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-1095175329\" referencedObject=\"ID_90320216-6c99-411f-a1de-32adaa210b97\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption><content styleCode=\"bold\">Keep the needle in your skin</content> after the dose counter has returned to &#x201C;0&#x201D;. <content styleCode=\"bold\">Count slowly to 6</content> to ensure that the full dose has been delivered. See figure O.</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-220753526\" referencedObject=\"ID_182e8bca-7cc2-48fa-87e2-9904c9bcb3f3\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Carefully remove the needle from your skin. See figure P. If blood appears at the injection site, press lightly with a gauze pad. Do not rub the area.</item></list><paragraph>&#xA71F;You may see a drop of Norditropin at the needle tip after injecting. This is normal and does not affect your dose.</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-1333527336\" referencedObject=\"ACFDD4D2-5B3B-41D2-B866-EE2AF5C7C52E\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Step 5. After your injection</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Carefully remove the needle from the Pen by turning the needle counterclockwise. See figure Q.</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id1698271051\" referencedObject=\"AD5AB634-20F0-492D-9245-9728E206D622\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Place the needle in a sharps disposal container immediately to reduce the risk of a needle stick. See figure R.</item></list><paragraph>&#xA71F;Always dispose of the needle after each injection.</paragraph><list listType=\"unordered\"><item><caption> </caption>For further information about safe sharps disposal, see <content styleCode=\"bold\">Frequently Asked Questions</content>.</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-1913689255\" referencedObject=\"C2E3F111-F890-4DC0-8975-53C9C5BB60B3\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">&#xA71F;Do not try to put the needle cap back on</content>. You may stick yourself with the needle.</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Put the Pen cap on your Pen after each use to protect the Norditropin from direct light. See figure S. </item><item><caption> </caption><content styleCode=\"bold\">See &#x201C;How should I store Norditropin?&#x201D;</content></item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-1986932516\" referencedObject=\"ID_2781b6da-fadd-4925-b990-d554f0c44f68\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Always remove the needle from your Pen. This reduces the risk of contamination, infection, leakage of Norditropin, and blocked needles leading to incorrect dosing.</item></list><paragraph><content styleCode=\"bold\">How should I store Norditropin?</content></paragraph><list listType=\"unordered\"><item><caption>&#x2022;</caption><content styleCode=\"bold\">Before you use Norditropin FlexPro pens for the first time:</content></item><item><caption>&#x2022;</caption>Store your new, unused <content styleCode=\"bold\">Norditropin</content> pen in a refrigerator between 36&#xBA;F to 46&#xBA;F (2&#xBA;C to 8&#xBA;C). </item><item><caption>&#x2022;</caption>Do not freeze <content styleCode=\"bold\">Norditropin</content>. </item><item><caption>&#x2022;</caption>When stored in the refrigerator, do not store <content styleCode=\"bold\">Norditropin</content> directly next to the cooling element.</item><item><caption>&#x2022;</caption>Keep <content styleCode=\"bold\">Norditropin</content> away from direct light.</item><item><caption>&#x2022;</caption>Do not use <content styleCode=\"bold\">Norditropin</content> that has been frozen or in temperatures warmer than 77&#xBA;F (25&#xBA;C).</item><item><caption>&#x2022;</caption>Do not use <content styleCode=\"bold\">Norditropin</content> after the expiration date printed on the carton and the pen.</item><item><caption>&#x2022;</caption><content styleCode=\"bold\">After you use Norditropin FlexPro pens and there is still medicine left:</content></item><item><caption>&#x2022;</caption>Store remaining <content styleCode=\"bold\">Norditropin</content> in the refrigerator between 36&#xBA;F to 46&#xBA;F (2&#xBA;C to 8&#xBA;C) and use within 4 weeks, or </item><item><caption>&#x2022;</caption>Store remaining <content styleCode=\"bold\">Norditropin</content> at room temperature no warmer than 77&#xBA;F (25&#xBA;C) and use within 3 </item><item><caption> </caption>weeks.</item><item><caption> </caption><content styleCode=\"bold\">Keep Norditropin and all medicines out of the reach of children.</content></item></list></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Frequently Asked Questions</content></paragraph><paragraph><content styleCode=\"bold\">How do I see how </content></paragraph><paragraph><content styleCode=\"bold\">much Norditropin is </content></paragraph><paragraph><content styleCode=\"bold\">left in my Pen?</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"/><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"/></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>The Pen scale shows you approximately how much Norditropin is left in your Pen. See figure T.</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-508831711\" referencedObject=\"ID_045d6ffb-c40a-492f-aa60-8578e3717b9d\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>To see how much Norditropin is left in your Pen, use the dose counter: Turn the dose selector clockwise until the dose counter stops. The dose pointer will line up with the number of &#x201C;mg&#x201D; left in the Pen. You can select a maximum dose of 2.0 mg. If the dose counter stops with the dose pointer lined up with &#x201C;2.0&#x201D;, at least 2.0 mg are left in your Pen. </paragraph><paragraph>If the dose counter stops with the dose pointer lined up with &#x201C;1.25&#x201D;, only 1.25 mg are left in your Pen. See figure U.</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-857339633\" referencedObject=\"E997F65A-E9D4-4852-9195-1B0CEA85E5EA\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">What if I need a larger dose than what is left in my Pen? </content></paragraph><paragraph>It is not possible to select a larger dose on the dose counter than the number of &#x201C;mg&#x201D; left in your Pen.</paragraph><paragraph>If you need more Norditropin than you have left in your Pen, you can use a new Pen or split your dose between your current Pen and a new Pen. <content styleCode=\"bold\">Only split your dose if you have been trained or advised by your healthcare provider on how to do this. </content>You may find it helpful to use a calculator to plan the doses as instructed by your healthcare provider.</paragraph><paragraph><content styleCode=\"bold\">Be very careful to calculate your split dose correctly so that you do not give the wrong dose</content>. If you are not sure how to split your dose using two Pens, then select and inject the dose you need with a new Pen.</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">What if no Norditropin appears when I check the flow?</content></paragraph><paragraph><content styleCode=\"bold\">A. Your needle may be blocked or damaged</content>, if no Norditropin appears at the needle tip. Remove the needle as described in step 5 and repeat steps 1 and 2.</paragraph><paragraph><content styleCode=\"bold\">B. Your Pen may be defective</content>, if Norditropin still does not appear after changing the needle. Do not use the Pen. Contact Novo Nordisk at 1-888-668-6444.</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">What if &#x201C;0&#x201D; does not appear after completing my injection?</content></paragraph><paragraph>The needle may be blocked or damaged, and <content styleCode=\"bold\">you have not received any Norditropin</content> &#x2013; even though the dose counter has moved from the dose that you have set. Remove the needle as described in step 5 and repeat steps 1 to 4.</paragraph><paragraph>If &#x201C;0&#x201D; still does not appear after completing the injection, contact Novo Nordisk at 1-888-668-6444.</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">How should I take care of my Pen?</content></paragraph><paragraph>Be careful not to drop your Pen or knock it against hard surfaces. Do not expose your Pen to dust, dirt, liquid, or direct light.</paragraph><paragraph>See <content styleCode=\"bold\">&#x201C;How should I store Norditropin?&#x201D;. </content></paragraph><paragraph>Do not try to refill your Pen, it is already prefilled. When your Pen is empty, throw it away and use a new pen. See &#x201C;<content styleCode=\"bold\">How do I dispose of used needles and Pens?</content>&#x201D;.</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Frequently Asked Questions</content></paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">What if I drop my Pen?</content></paragraph><paragraph>If you drop your Pen or think that something is wrong with it, attach a new disposable needle and check the Norditropin flow before you inject, see steps 1 and 2. Do not try to repair your Pen or pull it apart.</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">How do I clean my Pen?</content></paragraph><paragraph>Do not wash, soak, or lubricate your Pen. If necessary, clean it with mild detergent on a moistened cloth.</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">How do I dispose of used needles and Pens?</content></paragraph><paragraph>Put your used needles in an FDA-cleared sharps disposal container right away after use. <content styleCode=\"bold\">Do not throw away (dispose of) loose needles in your household trash</content>. If you do not have an FDA-cleared sharps disposal container, you may use a household container that is: </paragraph><list listType=\"unordered\"><item><caption>&#x2022;</caption>made of a heavy-duty plastic, </item><item><caption>&#x2022;</caption>can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, </item><item><caption>&#x2022;</caption>upright and stable during use, </item><item><caption>&#x2022;</caption>leak-resistant, and </item><item><caption>&#x2022;</caption>properly labeled to warn of hazardous waste inside the container.</item></list><paragraph>When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should dispose of used needles and Pens. For more information about safe sharps disposal, and for specific information about safe sharps disposal in the state that you live in, go to the FDA&#x2019;s website at: <linkHtml href=\"http://www.fda.gov/safesharpsdisposal\">http://www.fda.gov/safesharpsdisposal</linkHtml>.</paragraph><paragraph>Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this.</paragraph><paragraph>Do not recycle your used sharps disposal container.</paragraph><paragraph>When there is not enough medicine left in your Pen for your prescribed dose, the Pen may be thrown away in your household trash after you have removed the needle.</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">&#xA71F;Important information</content></paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Caregivers must <content styleCode=\"bold\">be very careful when handling needles</content> to reduce the risk of needle sticks and infection.</item><item><caption>&#x2022;</caption>Norditropin<sup>&#xAE;</sup> FlexPro<sup>&#xAE;</sup> 5 mg/1.5 mL Pen <content styleCode=\"bold\">is compatible with FlexPro<sup>&#xAE;</sup> PenMate<sup>&#xAE;</sup>.</content></item></list></td></tr><tr><td align=\"center\" colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-855339967\" referencedObject=\"EBAAB75D-40FF-457F-9576-3BB125D7AEC1\"/><paragraph><linkHtml href=\"http://www.norditropin.com\">www.norditropin.com</linkHtml></paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>This Instructions for Use has been approved by the U.S. Food and Drug Administration.</paragraph><paragraph><content styleCode=\"italics\">Norditropin</content><content styleCode=\"bold\"><sup>&#xAE;</sup></content> and <content styleCode=\"italics\">FlexPro</content><content styleCode=\"bold\"><sup>&#xAE;</sup></content> are registered trademarks of Novo Nordisk Health Care AG.</paragraph><paragraph><content styleCode=\"italics\">Novo Nordisk</content><content styleCode=\"bold\"><sup>&#xAE;</sup></content> and <content styleCode=\"italics\">PenMate</content><content styleCode=\"bold\"><sup>&#xAE; </sup></content>are registered trademarks of Novo Nordisk A/S.</paragraph><paragraph>PATENT Information: http://novonordisk-us.com/products/product-patents.html</paragraph><paragraph>Manufactured by:</paragraph><paragraph>Novo Nordisk Inc.</paragraph><paragraph>800 Scudders Mill Road</paragraph><paragraph>Plainsboro, NJ 08536 </paragraph><paragraph>U.S. License No. 1261</paragraph><paragraph>For information about NORDITROPIN<sup>&#xAE;</sup></paragraph><paragraph>Visit: norditropin.com</paragraph><paragraph>Or call: 1 (888) 668-6444</paragraph><paragraph>Revised: 01/2025</paragraph><paragraph>&#xA9; 2025 Novo Nordisk A/S</paragraph></td></tr></tbody></table>","<table width=\"100%\"><col width=\"50%\"/><col width=\"50%\"/><tbody><tr><td align=\"center\" colspan=\"2\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><renderMultiMedia ID=\"id-870445576\" referencedObject=\"D634618E-CEAC-49AB-BC6D-319A86EDBE02\"/></td></tr><tr><td align=\"center\" colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-1286350008\" referencedObject=\"ID_567ce33d-c852-4580-826c-b12af3a79c28\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Norditropin FlexPro Pen is for single-patient-use only.</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Supplies you will need:</content></paragraph><list listType=\"unordered\"><item><caption>&#x2022;</caption>Norditropin FlexPro prefilled Pen new injection needle. Norditropin prefilled Pen is designed to be used with all Novo Nordisk disposable needles up to a length of 8 mm.</item><item><caption>&#x2022;</caption>sharps disposal container. See step 5 for information on how to throw away (dispose of) used needles and Pens.</item><item><caption>&#x2022;</caption>alcohol pad</item><item><caption>&#x2022;</caption>gauze pad</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-2094846594\" referencedObject=\"ID_852025b6-7c33-4cdb-88b0-6ed61d6331ad\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">How to use your Norditropin FlexPro Pen</content></paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">5 steps you should follow for a Norditropin injection:</content></paragraph><list listType=\"unordered\"><item><caption> </caption>Step 1: Prepare your Norditropin FlexPro Pen </item><item><caption> </caption>Step 2: Check the Norditropin flow with each new Pen </item><item><caption> </caption>Step 3: Select your dose</item><item><caption> </caption>Step 4: Inject your dose</item><item><caption> </caption>Step 5: After your injection</item></list><paragraph><content styleCode=\"bold\">For further information about your Pen see:</content></paragraph><list listType=\"unordered\"><item><caption> </caption>Frequently Asked Questions</item><item><caption> </caption>Important information</item><item><caption> </caption>Patient Information </item></list><paragraph><content styleCode=\"bold\">&#xA71D;Important information</content></paragraph><paragraph>Make sure that you read this information carefully.</paragraph><paragraph><content styleCode=\"bold\">&#xA71F;Additional information</content></paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Norditropin is for use under the skin only (subcutaneous).</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Do not</content> share your Norditropin Pen and needles with another person. You may give another person an infection or get an infection from them. </paragraph><paragraph><content styleCode=\"bold\">Do not use your Pen without proper training from your healthcare provider</content>. </paragraph><paragraph>Make sure that you are confident in giving an injection with the Pen before you start your treatment.</paragraph><paragraph>If you are blind or have poor eyesight and cannot read the dose counter on the Pen, do not use this Pen without help. Get help from a person with good eyesight who is trained to use the Pen.</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Step 1. Prepare your Norditropin FlexPro Pen</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Wash your hands with soap and water. </item><item><caption> </caption><list listType=\"ordered\"><item><caption>&#x2022;</caption><content styleCode=\"bold\">Check the name, strength, and colored label </content>on your Pen to make sure that it contains Norditropin in the right strength. </item></list></item><item><caption> </caption><list listType=\"ordered\"><item><caption>&#x2022;</caption>Pull off the Pen cap. </item></list></item><item><caption> </caption><list listType=\"ordered\"><item><caption>&#x2022;</caption>Turn the Pen upside down 1 or 2 times to check that the Norditropin in your Pen is clear and colorless. See figure A. <content styleCode=\"bold\">If the Norditropin looks cloudy, do not use the Pen.</content></item></list></item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-596243184\" referencedObject=\"ID_1bedc0d4-c2d6-429a-996c-69b89379e3ea\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>When you are ready to give your injection, take a new disposable needle, and remove the paper tab. </item><item><caption>&#x2022;</caption>Push the needle straight onto the Pen. Turn the needle clockwise <content styleCode=\"bold\">until it is on tight</content>. See figure B.</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-1359044005\" referencedObject=\"ID_53ec1101-1596-49d6-9bb3-82223fe3581e\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">&#xA71F;Always use a new needle for each injection.</content> This reduces the risk of contamination, infection, leakage of Norditropin, and blocked needles leading to incorrect dosing.</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Pull off the outer needle cap and <content styleCode=\"bold\">dispose of it</content>. See figure C.</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-154377509\" referencedObject=\"ID_03a9128d-f9f6-4588-862d-a619ffc4d6f8\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Pull off the inner needle cap and dispose of it. See figure D.</item></list><paragraph>&#xA71F;A drop of Norditropin may appear at the needle tip. This is normal, but you must still check the Norditropin flow with each new Pen. See step 2.</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-932516676\" referencedObject=\"E5BAFD75-2C22-41E0-B08E-67456C1BAA94\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">&#xA71D;Never use a bent or damaged needle</content>.</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Step 2. Check the Norditropin flow with each new Pen</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">&#xA71F;If your Pen is already in use</content>, go to step 3.</paragraph><list listType=\"unordered\"><item><caption> </caption><content styleCode=\"bold\">Before using a new Pen</content>, check the Norditropin flow to make sure the growth hormone can flow through the Pen and needle.</item></list><list listType=\"ordered\"><item><caption>1.</caption>Turn the dose selector clockwise 1 tick marking on the dose counter to select 0.05 mg. You will hear a faint &#x201C;click&#x201D; when you turn the dose selector. See figure E.</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id1776445664\" referencedObject=\"ID_26ed067e-1a63-450d-bb07-588aeb531794\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption><content styleCode=\"bold\">1 marking on the dose counter equals 0.05 mg</content>. See figure F.</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id688639174\" referencedObject=\"ID_31f11529-65fd-4993-be68-3d239f46022d\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Hold the Pen with the needle pointing up. Press and hold in the dose button until the dose counter returns to &#x201C;0&#x201D;. <content styleCode=\"bold\">The &#x201C;0&#x201D; must line up with the dose pointer</content>. See figure G.</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-306708811\" referencedObject=\"ID_58775964-ffad-4928-85ee-14e367d193f6\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Check that a drop of Norditropin appears at the needle tip. See figure H.</item></list><paragraph><content styleCode=\"bold\">&#xA71F;If no Norditropin appears</content>, repeat step 2 up to 6 times.</paragraph><paragraph>If you still do not see a drop of Norditropin, <content styleCode=\"bold\">change the needle:</content></paragraph><list listType=\"unordered\"><item><caption>&#x2022;</caption>Carefully remove the needle from the Pen by turning the needle counterclockwise. Place the needle in a sharps disposal container immediately. See step 5.</item><item><caption>&#x2022;</caption>and repeat step 2 again.</item><item><caption> </caption><content styleCode=\"bold\">Do not use the Pen if a drop of Norditropin still does not appear after changing the needle and repeating step 2. Call Novo Nordisk at </content></item><item><caption> </caption><content styleCode=\"bold\">1-888-668-6444 for help.</content></item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-1369756190\" referencedObject=\"ID_21207add-36c6-40ec-8ccd-eefc27404a28\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Step 3. Select your dose</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>To start, check that the dose pointer is set at <content styleCode=\"bold\">&#x201C;0&#x201D;.</content></item><item><caption>&#x2022;</caption>Turn the dose selector clockwise to select the dose you need. See figure I.</item><item><caption> </caption>When you have selected your dose, you can go to step 4.</item></list><paragraph><content styleCode=\"bold\">&#xA71F;If there is not enough Norditropin left </content>to select a full dose, see <content styleCode=\"bold\">Frequently Asked Questions</content><content styleCode=\"italics\">.</content></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id655804076\" referencedObject=\"ID_35d7c0de-2b46-4590-acaa-923c7aed2b30\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>&#xA71F;The dose counter shows the dose in &#x201C;mg&#x201D;. See figures J and K. Always use the dose counter to select the exact dose<content styleCode=\"bold\">. Do not use the &#x201C;click&#x201D; sounds you hear when you turn the dose selector or the Pen scale to select your dose. Only the dose pointer on the dose counter will show the exact dose selected.</content></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-1208871398\" referencedObject=\"DDCB072A-B539-4884-B92D-3B9230379205\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"/><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id627593348\" referencedObject=\"E7D941C6-E696-413A-91D2-E5A58EF7DFF5\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>&#xA71F;If you select the wrong dose, you can turn the dose selector clockwise or counterclockwise to the correct dose. See figure L.</paragraph><list listType=\"unordered\"><item><caption> </caption>The Pen &#x201C;clicks&#x201D; sound and feel differently when the dose selector is turned clockwise, counterclockwise, or if you forcefully move it past the number of &#x201C;mg&#x201D; left in the Pen.</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-868525148\" referencedObject=\"ID_7ce5cca3-53cf-4aed-8c6d-89c1bcc9af7e\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Step 4. Inject your dose</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Select the injection site.</item><item><caption> </caption><list listType=\"ordered\"><item><caption>&#x2022;</caption>Norditropin can be injected under the skin (subcutaneously) of your stomach area (abdomen), buttocks, upper legs (thighs), or upper arms, as instructed by your healthcare provider. <content styleCode=\"bold\">Change the injection site every day</content>. </item></list></item><item><caption>&#x2022;</caption>Wipe the injection site with an alcohol swab and let the area dry.</item><item><caption>&#x2022;</caption>Insert the needle into your skin as your healthcare provider has shown you. See figure M.</item><item><caption> </caption>Make sure you can see the dose counter. <content styleCode=\"bold\">Do not cover it with your fingers</content>. This could block the injection.</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id1182316676\" referencedObject=\"ID_7928ab0a-296d-48c0-9a82-5bcb8f1152c7\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Press and hold down the dose button until the dose counter shows &#x201C;0&#x201D;. See figure N. <content styleCode=\"bold\">The &#x201C;0&#x201D; must line up with the dose pointer</content>. You may then hear or feel a &#x201C;click&#x201D;. </item><item><caption>&#x2022;</caption><content styleCode=\"bold\">Continue to hold the needle in your skin.</content></item></list><paragraph>&#xA71F;If &#x201C;0&#x201D; does not appear in the dose counter after continuously pressing the dose button, your needle may be blocked or damaged, see <content styleCode=\"bold\">Frequently Asked Questions</content>. </paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id531392548\" referencedObject=\"C28A4148-6CA0-40B3-87C8-BCFD9161ADA7\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption><content styleCode=\"bold\">Keep the needle in your skin</content> after the dose counter has returned to &#x201C;0&#x201D;. <content styleCode=\"bold\">Count slowly to 6</content> to ensure that the full dose has been delivered. See figure O.</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id1520589604\" referencedObject=\"ID_0e947c06-b1ec-4e1e-bbf5-026b37ea4983\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Carefully remove the needle from your skin. See figure P. If blood appears at the injection site, press lightly with a gauze pad. Do not rub the area.</item></list><paragraph>&#xA71F;You may see a drop of Norditropin at the needle tip after injecting. This is normal and does not affect your dose.</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-1899506582\" referencedObject=\"ID_359a2fb9-7929-4ca1-929f-79fb895cbdba\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Step 5. After your injection</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Carefully remove the needle from the Pen by turning the needle counterclockwise. See figure Q.</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-647820017\" referencedObject=\"F1D96CB7-A0F6-4D52-A3CD-7C0E8AD6E019\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Place the needle in a sharps disposal container immediately to reduce the risk of a needle stick. See figure R.</item></list><paragraph>&#xA71F;Always dispose of the needle after each injection.</paragraph><list listType=\"unordered\"><item><caption> </caption>For further information about safe sharps disposal, see <content styleCode=\"bold\">Frequently Asked Questions</content>.</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id835350278\" referencedObject=\"CFF580E2-D355-4892-82A2-9421051A702F\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">&#xA71D;Do not try to put the needle cap back on</content>. You may stick yourself with the needle.</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Put the Pen cap on your Pen after each use to protect the Norditropin from direct light. See figure S.</item><item><caption> </caption>See <content styleCode=\"bold\">&#x201C;How should I store Norditropin?&#x201D;.</content></item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-1765373586\" referencedObject=\"ID_1072c384-dc80-47f9-910f-bfe4424428c9\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>&#xA71D;Always remove the needle from your Pen. This reduces the risk of contamination, infection, leakage of Norditropin, and blocked needles leading to incorrect dosing.</paragraph><list listType=\"unordered\"><item><caption> </caption><content styleCode=\"bold\">How should I store Norditropin?</content></item></list><paragraph>&#x2022;<content styleCode=\"bold\">Before you use Norditropin FlexPro pens for the first time: </content></paragraph><list listType=\"unordered\"><item><caption>&#x2022;</caption>Store your new, unused <content styleCode=\"bold\">Norditropin</content> pen in a refrigerator between 36&#xBA;F to 46&#xBA;F (2&#xBA;C to 8&#xBA;C). </item><item><caption>&#x2022;</caption>Do not freeze <content styleCode=\"bold\">Norditropin</content>. </item><item><caption>&#x2022;</caption>When stored in the refrigerator, do not store <content styleCode=\"bold\">Norditropin</content> directly next to the cooling element.</item><item><caption>&#x2022;</caption>Keep <content styleCode=\"bold\">Norditropin</content> away from direct light.</item><item><caption>&#x2022;</caption>Do not use <content styleCode=\"bold\">Norditropin</content> that has been frozen or in temperatures warmer than 77&#xBA;F (25&#xBA;C).</item><item><caption>&#x2022;</caption>Do not use <content styleCode=\"bold\">Norditropin</content> after the expiration date printed on the carton and the pen.</item></list><paragraph>&#x2022;<content styleCode=\"bold\">After you use Norditropin FlexPro pens and there is still medicine left: </content></paragraph><list listType=\"unordered\"><item><caption>&#x2022;</caption>Store remaining <content styleCode=\"bold\">Norditropin</content> in the refrigerator between 36&#xBA;F to 46&#xBA;F (2&#xBA;C to 8&#xBA;C) and use within 4 weeks, or </item><item><caption>&#x2022;</caption>Store remaining <content styleCode=\"bold\">Norditropin </content>at room temperature no warmer than 77&#xBA;F (25&#xBA;C) and use within 3 weeks.</item></list><paragraph><content styleCode=\"bold\">Keep Norditropin and all medicines out of the reach of children.</content></paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Frequently Asked Questions</content></paragraph><paragraph><content styleCode=\"bold\">How do I see how </content></paragraph><paragraph><content styleCode=\"bold\">much Norditropin is </content></paragraph><paragraph><content styleCode=\"bold\">left in my Pen?</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>The Pen scale shows you approximately how much Norditropin is left in your Pen. See figure T.</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-796533184\" referencedObject=\"ID_6b3947de-80dc-410e-9038-d835275333fe\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>To see how much Norditropin is left in your Pen, use the dose counter: Turn the dose selector clockwise until the dose counter stops. The dose pointer will line up with the number of &#x201C;mg&#x201D; left in the Pen. You can select a maximum dose of 4.0 mg. If the dose counter stops with the dose pointer lined up with &#x201C;4.0&#x201D;, at least 4.0 mg are left in your Pen. </paragraph><paragraph>If the dose counter stops with the dose pointer lined up with &#x201C;2.4&#x201D;, only 2.4 mg are left in your Pen. See figure U.</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id2070918056\" referencedObject=\"D15C82FB-62F2-4BFF-81A8-9B12C15C879C\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">What if I need a larger dose than what is left in my Pen? </content></paragraph><paragraph>It is not possible to select a larger dose on the dose counter than the number of &#x201C;mg&#x201D; left in your Pen.</paragraph><paragraph>If you need more Norditropin than you have left in your Pen, you can use a new Pen or split your dose between your current Pen and a new Pen. <content styleCode=\"bold\">Only split your dose if you have been trained or advised by your healthcare provider on how to do this.</content> You may find it helpful to use a calculator to plan the doses as instructed by your healthcare provider.</paragraph><paragraph><content styleCode=\"bold\">Be very careful to calculate your split dose correctly so that you do not give the wrong dose</content>. If you are not sure how to split your dose using two Pens, then select and inject the dose you need with a new Pen.</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">What if no Norditropin appears when I check the flow?</content></paragraph><paragraph><content styleCode=\"bold\">A. Your needle may be blocked or damaged</content>, if no Norditropin appears at the needle tip. Remove the needle as described in step 5 and repeat steps 1 and 2.</paragraph><paragraph><content styleCode=\"bold\">B. Your Pen may be defective</content>, if Norditropin still does not appear after changing the needle. Do not use the Pen. Contact Novo Nordisk at 1-888-668-6444.</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">What if &#x201C;0&#x201D; does not appear after completing my injection?</content></paragraph><paragraph>The needle may be blocked or damaged, and <content styleCode=\"bold\">you have not received any Norditropin</content> &#x2013; even though the dose counter has moved from the dose that you have set. Remove the needle as described in step 5 and repeat steps 1 to 4.</paragraph><paragraph>If &#x201C;0&#x201D; still does not appear after completing the injection, contact Novo Nordisk at 1-888-668-6444.</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">How should I take care of my Pen?</content></paragraph><paragraph>Be careful not to drop your Pen or knock it against hard surfaces. Do not expose your Pen to dust, dirt, liquid, or direct light.</paragraph><paragraph>See <content styleCode=\"bold\">&#x201C;How should I store Norditropin?&#x201D;. </content></paragraph><paragraph>Do not try to refill your Pen, it is already prefilled. When your Pen is empty, throw it away and use a new pen. See &#x201C;<content styleCode=\"bold\">How do I dispose of used needles and Pens?</content>&#x201D;.</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Frequently Asked Questions</content></paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">What if I drop my Pen?</content></paragraph><paragraph>If you drop your Pen or think that something is wrong with it, attach a new disposable needle and check the Norditropin flow before you inject, see steps 1 and 2. Do not try to repair your Pen or pull it apart.</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">How do I clean my Pen?</content></paragraph><paragraph>Do not wash, soak, or lubricate your Pen. If necessary, clean it with mild detergent on a moistened cloth. </paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">How do I dispose of used needles and Pens?</content></paragraph><paragraph>Put your used needles in an FDA-cleared sharps disposal container right away after use. <content styleCode=\"bold\">Do not throw away (dispose of) loose needles in your household trash</content>. If you do not have an FDA-cleared sharps disposal container, you may use a household container that is: </paragraph><list listType=\"ordered\"><item><caption> </caption>&#x2022; made of a heavy-duty plastic, </item><item><caption> </caption>&#x2022; can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, </item><item><caption> </caption>&#x2022; upright and stable during use, </item><item><caption> </caption>&#x2022; leak-resistant, and </item><item><caption> </caption>&#x2022; properly labeled to warn of hazardous waste inside the container.</item></list><paragraph>When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should dispose of used needles and Pens. For more information about safe sharps disposal, and for specific information about safe sharps disposal in the state that you live in, go to the FDA&#x2019;s website at: http://www.fda.gov/safesharpsdisposal.  </paragraph><paragraph>Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this.</paragraph><paragraph>Do not recycle your used sharps disposal container.</paragraph><paragraph>When there is not enough medicine left in your Pen for your prescribed dose, the Pen may be thrown away in your household trash after you have removed the needle.</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">&#xA71D;Important information</content></paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Caregivers must <content styleCode=\"bold\">be very careful when handling needles</content> to reduce the risk of needle sticks and infection.</item><item><caption>&#x2022;</caption>Norditropin<sup>&#xAE;</sup> FlexPro<sup>&#xAE;</sup> 10 mg/1.5 mL Pen <content styleCode=\"bold\">is compatible with FlexPro<sup>&#xAE;</sup> PenMate<sup>&#xAE;</sup>.</content></item></list></td></tr><tr><td align=\"center\" colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id1219404276\" referencedObject=\"EF74090D-221C-49C3-A32E-653222E6C8C0\"/><paragraph><linkHtml href=\"http://www.norditropin.com\">www.norditropin.com</linkHtml></paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>This Instructions for Use has been approved by the U.S. Food and Drug Administration.</paragraph><paragraph><content styleCode=\"italics\">Norditropin</content><sup>&#xAE;</sup> and <content styleCode=\"italics\">FlexPro</content><content styleCode=\"bold\"><sup>&#xAE;</sup></content> are registered trademarks of Novo Nordisk Health Care AG.</paragraph><paragraph><content styleCode=\"italics\">Novo Nordisk</content><content styleCode=\"bold\"><sup>&#xAE;</sup></content> and <content styleCode=\"italics\">PenMate</content><content styleCode=\"bold\"><sup>&#xAE; </sup></content>are registered trademarks of Novo Nordisk A/S.</paragraph><paragraph>PATENT Information: <linkHtml href=\"http://novonordisk-us.com/products/product-patents.html\">http://novonordisk-us.com/products/product-patents.html</linkHtml></paragraph><paragraph>Manufactured by:</paragraph><paragraph>Novo Nordisk Inc.</paragraph><paragraph>800 Scudders Mill Road</paragraph><paragraph>Plainsboro, NJ 08536 USA</paragraph><paragraph>U.S. License No. 1261</paragraph><paragraph>For information about NORDITROPIN<sup>&#xAE;</sup></paragraph><paragraph>Visit: norditropin.com</paragraph><paragraph>Or call: 1 (888) 668-6444</paragraph><paragraph>Revised: 01/2025</paragraph><paragraph>&#xA9; 2025 Novo Nordisk A/S</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"/><td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"/></tr></tbody></table>","<table width=\"100%\"><col width=\"50%\"/><col width=\"50%\"/><tbody><tr><td align=\"center\" colspan=\"2\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><renderMultiMedia ID=\"id260115962\" referencedObject=\"ID_109b292e-9a84-4ff6-bd1d-46a4024a884f\"/></td></tr><tr><td align=\"center\" colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-238943898\" referencedObject=\"ID_520abf51-105e-4d0e-ba1d-07e7f7b20ab6\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Norditropin FlexPro Pen is for single-patient-use only.</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Supplies you will need:</content></paragraph><list listType=\"unordered\"><item><caption>&#x2022;</caption>Norditropin FlexPro prefilled Pen new injection needle. Norditropin prefilled Pen is designed to be used with all Novo Nordisk disposable needles up to a length of 8 mm </item><item><caption>&#x2022;</caption>sharps disposal container. See step 5 for information on how to throw away (dispose of) used needles and Pens.</item><item><caption>&#x2022;</caption>alcohol pad</item><item><caption>&#x2022;</caption>gauze pad</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-1279335656\" referencedObject=\"B0BE28AB-C97B-44A4-A7BD-FCD9D674A7C1\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">How to use your Norditropin FlexPro Pen</content></paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">5 steps you should follow for a Norditropin injection:</content></paragraph><list listType=\"unordered\"><item><caption> </caption>Step 1: Prepare your Norditropin FlexPro Pen </item><item><caption> </caption>Step 2: Check the Norditropin flow with each new Pen </item><item><caption> </caption>Step 3: Select your dose</item><item><caption> </caption>Step 4: Inject your dose</item><item><caption> </caption>Step 5: After your injection</item></list><paragraph><content styleCode=\"bold\">For further information about your Pen see:</content></paragraph><list listType=\"unordered\"><item><caption> </caption>Frequently Asked Questions</item><item><caption> </caption>Important information</item><item><caption> </caption>Patient Information </item></list><paragraph><content styleCode=\"bold\">&#xA71D;Important information</content></paragraph><paragraph>Make sure that you read this information carefully.</paragraph><paragraph>&#xA71F;<content styleCode=\"bold\">Additional information</content></paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Norditropin is for use under the skin only (subcutaneous).</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Do not</content> share your Norditropin Pen and needles with another person. You may give another person an infection or get an infection from them. </paragraph><paragraph><content styleCode=\"bold\">Do not use your Pen without proper training from your healthcare provider</content>. </paragraph><paragraph>Make sure that you are confident in giving an injection with the Pen before you start your treatment. </paragraph><paragraph>If you are blind or have poor eyesight and cannot read the dose counter on the Pen, do not use this Pen without help. Get help from a person with good eyesight who is trained to use the Pen.</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Step 1. Prepare your Norditropin FlexPro Pen</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Wash your hands with soap and water. </item><item><caption>&#x2022;</caption><content styleCode=\"bold\">Check the name, strength, and colored label </content>on your Pen to make sure that it contains Norditropin in the right strength. </item><item><caption>&#x2022;</caption>Pull off the Pen cap. </item><item><caption>&#x2022;</caption>Turn the Pen upside down 1 or 2 times to check that the Norditropin in your Pen is clear and colorless.</item><item><caption>&#x2022;</caption>See figure A. <content styleCode=\"bold\">If the Norditropin looks cloudy, do not use the Pen.</content></item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-617599951\" referencedObject=\"ID_129bc329-f6f5-4ca6-8164-23e84020e4aa\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>When you are ready to give your injection, take a new disposable needle, and remove the paper tab. </item><item><caption>&#x2022;</caption>Push the needle straight onto the Pen. Turn the needle clockwise <content styleCode=\"bold\">until it is on tight</content>. See figure B.</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id203768889\" referencedObject=\"ID_56d2fde6-ae01-423f-861a-612f0816a65f\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">&#xA71D;Always use a new needle for each injection.</content> This reduces the risk of contamination, infection, leakage of Norditropin, and blocked needles leading to incorrect dosing.</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Pull off the outer needle cap and <content styleCode=\"bold\">dispose of it</content>. See figure C.</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-2008433805\" referencedObject=\"ID_77faefe0-23f1-4170-82e0-48312b7b6dc0\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Pull off the inner needle cap and dispose of it. See figure D.</item></list><paragraph>&#xA71F;A drop of Norditropin may appear at the needle tip. This is normal, but you must still check the Norditropin flow with each new Pen. See step 2.</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-611982190\" referencedObject=\"ID_00d5fe49-538f-4804-a494-c815cb4a794c\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">&#xA71D;Never use a bent or damaged needle</content>.</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Step 2. Check the Norditropin flow with each new Pen</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">&#xA71F;If your Pen is already in use</content>, go to step 3.</paragraph><list listType=\"unordered\"><item><caption> </caption><content styleCode=\"bold\">Before using a new Pen</content>, check the Norditropin flow to make sure the growth hormone can flow through the Pen and needle.</item></list><list listType=\"ordered\"><item><caption>1.</caption>Turn the dose selector clockwise 1 tick marking on the dose counter to select 0.1 mg. You will hear a faint &#x201C;click&#x201D; when you turn the dose selector. See figure E.</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id200983904\" referencedObject=\"DD99548E-B37F-46CE-8C90-C72297B395BB\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption><content styleCode=\"bold\">1 marking on the dose counter equals 0.1 mg</content>. See figure F.</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id85427497\" referencedObject=\"ID_1b3a8f15-bd6c-4107-8736-d14bbad07629\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Hold the Pen with the needle pointing up. Press and hold in the dose button until the dose counter returns to &#x201C;0&#x201D;. <content styleCode=\"bold\">The &#x201C;0&#x201D; must line up with the dose pointer</content>. See figure G.</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id1080332586\" referencedObject=\"ID_609f7539-5006-4fa9-afa9-dc0be98a0b29\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Check that a drop of Norditropin appears at the needle tip. See figure H.</item></list><paragraph><content styleCode=\"bold\">&#xA71F;If no Norditropin appears</content>, repeat step 2 up to 6 times.</paragraph><paragraph>If you still do not see a drop of Norditropin, <content styleCode=\"bold\">change the needle:</content></paragraph><list listType=\"unordered\"><item><caption>&#x2022;</caption>Carefully remove the needle from the Pen by turning the needle counterclockwise. Place the needle in a sharps disposal container immediately. See step 5.</item><item><caption>&#x2022;</caption>and repeat step 2 again.</item><item><caption> </caption><content styleCode=\"bold\">Do not use the Pen if a drop of Norditropin still does not appear after changing the needle and repeating step 2. Call Novo Nordisk at </content></item><item><caption> </caption><content styleCode=\"bold\">1-888-668-6444 for help.</content></item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id2113012975\" referencedObject=\"ID_86e6a135-633d-4a12-ac8f-d127cf17a749\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Step 3. Select your dose</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>To start, check that the dose pointer is set at <content styleCode=\"bold\">&#x201C;0&#x201D;.</content></item><item><caption>&#x2022;</caption>Turn the dose selector clockwise to select the dose you need. See figure I.</item><item><caption> </caption>When you have selected your dose, you can go to step 4. </item></list><paragraph><content styleCode=\"bold\">&#xA71F;If there is not enough Norditropin left </content>to select a full dose, see <content styleCode=\"bold\">Frequently Asked Questions</content><content styleCode=\"italics\">.</content></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id185570163\" referencedObject=\"ID_16bd4fe2-a222-4ef8-bb77-7657d180031b\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>&#xA71F;The dose counter shows the dose in &#x201C;mg&#x201D;. See figures J and K. Always use the dose counter to select the exact dose<content styleCode=\"bold\">. Do not use the &#x201C;click&#x201D; sounds you hear when you turn the dose selector or the Pen scale to select your dose.Only the dose pointer on the dose counter will show the exact dose selected.</content></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-314567994\" referencedObject=\"ID_1cd3a5bd-9209-4680-9fcb-12eb2d260760\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"/><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-2091002338\" referencedObject=\"ID_0abcbb59-9b74-4aad-95db-a4cc2ca606e9\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>&#xA71F;If you select the wrong dose, you can turn the dose selector clockwise or counterclockwise to the correct dose. See figure L.</paragraph><list listType=\"unordered\"><item><caption> </caption>The Pen &#x201C;clicks&#x201D; sound and feel differently when the dose selector is turned clockwise, counterclockwise, or if you forcefully move it past the number of &#x201C;mg&#x201D; left in the Pen.</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-1556152270\" referencedObject=\"ID_9fc5d0a7-056e-425f-b955-c7cba381064d\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Step 4. Inject your dose</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Select the injection site.</item><item><caption>&#x2022;</caption>Norditropin can be injected under the skin (subcutaneously) of your stomach area (abdomen), buttocks, upper legs (thighs), or upper arms, as instructed by your healthcare provider. Change the injection site every day.</item><item><caption>&#x2022;</caption>Wipe the injection site with an alcohol swab and let the area dry.</item><item><caption>&#x2022;</caption>Insert the needle into your skin as your healthcare provider has shown you. See figure M.</item><item><caption> </caption>Make sure you can see the dose counter. <content styleCode=\"bold\">Do not cover it with your fingers</content>. This could block the injection. </item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-665329626\" referencedObject=\"E215C155-66A2-41E0-A72E-118F14EF18A3\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Press and hold down the dose button until the dose counter shows &#x201C;0&#x201D;. See figure N. <content styleCode=\"bold\">The &#x201C;0&#x201D; must line up with the dose pointer</content>. You may then hear or feel a &#x201C;click&#x201D;. </item><item><caption>&#x2022;</caption><content styleCode=\"bold\">Continue to hold the needle in your skin. </content></item></list><paragraph>&#xA71F;If &#x201C;0&#x201D; does not appear in the dose counter after continuously pressing the dose button, your needle may be blocked or damaged, see <content styleCode=\"bold\">Frequently Asked Questions</content>.</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id837357766\" referencedObject=\"ID_8c1d8a83-d954-490f-ac97-289ff98393e3\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption><content styleCode=\"bold\">Keep the needle in your skin</content> after the dose counter has returned to &#x201C;0&#x201D;. <content styleCode=\"bold\">Count slowly to 6</content> to ensure that the full dose has been delivered. See figure O.</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-548152986\" referencedObject=\"ID_16236663-935b-49c8-82e7-0d5ea7bbb83d\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Carefully remove the needle from your skin. See figure P. If blood appears at the injection site, press lightly with a gauze pad. Do not rub the area.</item></list><paragraph>&#xA71F;You may see a drop of Norditropin at the needle tip after injecting. This is normal and does not affect your dose.</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-1152285710\" referencedObject=\"DE56370F-9883-4550-A4BB-0BAD50D0B709\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Step 5. After your injection</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Carefully remove the needle from the Pen by turning the needle counterclockwise. See figure Q.</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-1526390651\" referencedObject=\"C6202055-AEDD-4CC0-B2EA-67443C962E6B\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Place the needle in a sharps disposal container immediately to reduce the risk of a needle stick. See figure R.</item></list><paragraph>&#xA71F;Always dispose of the needle after each injection.</paragraph><list listType=\"unordered\"><item><caption> </caption>For further information about safe sharps disposal, see <content styleCode=\"bold\">Frequently Asked Questions</content>.</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id1604835374\" referencedObject=\"EA38CAA0-7205-404D-8AA8-74BB843C0E9A\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">&#xA71D;Do not try to put the needle cap back on</content>. You may stick yourself with the needle.</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Put the Pen cap on your Pen after each use to protect the Norditropin from direct light. See figure S.</item><item><caption> </caption>See <content styleCode=\"bold\">&#x201C;How should I store Norditropin?&#x201D;.</content></item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id1289706143\" referencedObject=\"A3E11A0A-1C27-482B-876B-62D04C7AB96E\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>&#xA71D;Always remove the needle from your Pen. This reduces the risk of contamination, infection, leakage of Norditropin, and blocked needles leading to incorrect dosing.</paragraph><list listType=\"unordered\"><item><caption> </caption><content styleCode=\"bold\">How should I store Norditropin?</content></item></list><paragraph>&#x2022;<content styleCode=\"bold\">Before you use Norditropin FlexPro pens for the first time: </content></paragraph><list listType=\"unordered\"><item><caption>&#x2022;</caption>Store your new, unused <content styleCode=\"bold\">Norditropin</content> pen in a refrigerator between 36&#xBA;F to 46&#xBA;F (2&#xBA;C to 8&#xBA;C).</item><item><caption>&#x2022;</caption>Do not freeze <content styleCode=\"bold\">Norditropin</content>. </item><item><caption>&#x2022;</caption>When stored in the refrigerator, do not store <content styleCode=\"bold\">Norditropin</content> directly next to the cooling element.</item><item><caption>&#x2022;</caption>Keep <content styleCode=\"bold\">Norditropin</content> away from direct light.</item><item><caption>&#x2022;</caption>Do not use <content styleCode=\"bold\">Norditropin</content> that has been frozen or in temperatures warmer than 77&#xBA;F (25&#xBA;C).</item><item><caption>&#x2022;</caption>Do not use <content styleCode=\"bold\">Norditropin</content> after the expiration date printed on the carton and the pen.</item><item><caption> </caption>&#x2022;<content styleCode=\"bold\">After you use Norditropin FlexPro pens and there is still medicine left: </content></item><item><caption>&#x2022;</caption>Store remaining <content styleCode=\"bold\">Norditropin</content> in the refrigerator between 36&#xBA;F to 46&#xBA;F (2&#xBA;C to 8&#xBA;C) and use within 4 weeks, or </item><item><caption>&#x2022;</caption>Store remaining <content styleCode=\"bold\">Norditropin</content> at room temperature no warmer than 77&#xBA;F (25&#xBA;C) and use within 3 weeks. </item></list><paragraph><content styleCode=\"bold\">Keep Norditropin and all medicines out of the reach of children.</content></paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Frequently Asked Questions</content></paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">How do I see how </content></paragraph><paragraph><content styleCode=\"bold\">much Norditropin is </content></paragraph><paragraph><content styleCode=\"bold\">left in my Pen?</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>The Pen scale shows you approximately how much Norditropin is left in your Pen. See figure T.</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-1037275073\" referencedObject=\"ID_7d699e1f-e663-4176-97e9-66e9fa05a8c4\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>To see how much Norditropin is left in your Pen, use the dose counter: Turn the dose selector clockwise until the dose counter stops. The dose pointer will line up with the number of &#x201C;mg&#x201D; left in the Pen. You can select a maximum dose of 8.0 mg. If the dose counter stops with the dose pointer lined up with &#x201C;8.0&#x201D;, at least 8.0 mg are left in your Pen.</paragraph><paragraph>If the dose counter stops with the dose pointer lined up with &#x201C;3.8&#x201D;, only 3.8 mg are left in your Pen. See figure U.</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id2018417270\" referencedObject=\"ID_240834c5-7a1b-4ad7-a6b5-16494388cec2\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">What if I need a larger dose than what is left in my Pen? </content></paragraph><paragraph>It is not possible to select a larger dose on the dose counter than the number of &#x201C;mg&#x201D; left in your Pen.</paragraph><paragraph>If you need more Norditropin than you have left in your Pen, you can use a new Pen or split your dose between your current Pen and a new Pen. <content styleCode=\"bold\">Only split your dose if you have been trained or advised by your healthcare provider on how to do this.</content> You may find it helpful to use a calculator to plan the doses as instructed by your healthcare provider.</paragraph><paragraph><content styleCode=\"bold\">Be very careful to calculate your split dose correctly so that you do not give the wrong dose</content>. If you are not sure how to split your dose using two Pens, then select and inject the dose you need with a new Pen.</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">What if no Norditropin appears when I check the flow?</content></paragraph><paragraph><content styleCode=\"bold\">A. Your needle may be blocked or damaged</content>, if no Norditropin appears at the needle tip. Remove the needle as described in step 5 and repeat steps 1 and 2.</paragraph><paragraph><content styleCode=\"bold\">B. Your Pen may be defective</content>, if Norditropin still does not appear after changing the needle. Do not use the Pen. Contact Novo Nordisk at 1-888-668-6444.</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">What if &#x201C;0&#x201D; does not appear after completing my injection?</content></paragraph><paragraph>The needle may be blocked or damaged, and <content styleCode=\"bold\">you have not received any Norditropin</content> &#x2013; even though the dose counter has moved from the dose that you have set. Remove the needle as described in step 5 and repeat steps 1 to 4.</paragraph><paragraph>If &#x201C;0&#x201D; still does not appear after completing the injection, contact Novo Nordisk at 1-888-668-6444.</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">How should I take care of my Pen?</content></paragraph><paragraph>Be careful not to drop your Pen or knock it against hard surfaces. Do not expose your Pen to dust, dirt, liquid, or direct light.</paragraph><paragraph>See &#x201C;<content styleCode=\"bold\">How should I store Norditropin?&#x201D;. </content></paragraph><paragraph>Do not try to refill your Pen, it is already prefilled. When your Pen is empty, throw it away and use a new pen. See &#x201C;<content styleCode=\"bold\">How do I dispose of used needles and Pens?</content>&#x201D;.</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Frequently Asked Questions</content></paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">What if I drop my Pen?</content></paragraph><paragraph>If you drop your Pen or think that something is wrong with it, attach a new disposable needle and check the Norditropin flow before you inject, see steps 1 and 2. Do not try to repair your Pen or pull it apart.</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">How do I clean my Pen?</content></paragraph><paragraph>Do not wash, soak, or lubricate your Pen. If necessary, clean it with mild detergent on a moistened cloth.</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">How do I dispose of used needles and Pens?</content></paragraph><paragraph>Put your used needles in an FDA-cleared sharps disposal container right away after use. <content styleCode=\"bold\">Do not throw away (dispose of) loose needles in your household trash</content>. If you do not have an FDA-cleared sharps disposal container, you may use a household container that is: </paragraph><list listType=\"ordered\"><item><caption> </caption>&#x2022; made of a heavy-duty plastic, </item><item><caption> </caption>&#x2022; can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, </item><item><caption> </caption>&#x2022; upright and stable during use, </item><item><caption> </caption>&#x2022; leak-resistant, and </item><item><caption> </caption>&#x2022; properly labeled to warn of hazardous waste inside the container.</item></list><paragraph>When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should dispose of used needles and Pens. For more information about safe sharps disposal, and for specific information about safe sharps disposal in the state that you live in, go to the FDA&#x2019;s website at: <linkHtml href=\"http://www.fda.gov/safesharpsdisposal\">http://www.fda.gov/safesharpsdisposal</linkHtml>.</paragraph><paragraph>Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this.</paragraph><paragraph>Do not recycle your used sharps disposal container.</paragraph><paragraph>When there is not enough medicine left in your Pen for your prescribed dose, the Pen may be thrown away in your household trash after you have removed the needle.</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">&#xA71F;Important information</content></paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Caregivers must <content styleCode=\"bold\">be very careful when handling needles</content> to reduce the risk of needle sticks and infection.</item><item><caption>&#x2022;</caption>Norditropin<sup>&#xAE;</sup> FlexPro<sup>&#xAE;</sup> 15 mg/1.5 mL Pen <content styleCode=\"bold\">is compatible with FlexPro<sup>&#xAE;</sup> PenMate<sup>&#xAE;</sup>.</content></item></list></td></tr><tr><td align=\"center\" colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id227658921\" referencedObject=\"B4262018-A2F3-4727-A3ED-CD03C8A4AB55\"/><paragraph>www.norditropin.com</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>This Instructions for Use has been approved by the U.S. Food and Drug Administration.</paragraph><paragraph><content styleCode=\"italics\">Norditropin</content><sup>&#xAE;</sup> and <content styleCode=\"italics\">FlexPro</content><content styleCode=\"bold\"><sup>&#xAE;</sup></content> are registered trademarks of Novo Nordisk Health Care AG.</paragraph><paragraph><content styleCode=\"italics\">Novo Nordisk</content><content styleCode=\"bold\"><sup>&#xAE;</sup></content> and <content styleCode=\"italics\">PenMate</content><content styleCode=\"bold\"><sup>&#xAE; </sup></content>are registered trademarks of Novo Nordisk A/S.</paragraph><paragraph>PATENT Information: http://novonordisk-us.com/products/product-patents.html</paragraph><paragraph>Manufactured by:</paragraph><paragraph>Novo Nordisk Inc.</paragraph><paragraph>800 Scudders Mill Road</paragraph><paragraph>Plainsboro, NJ 08536 </paragraph><paragraph>U.S. License No. 1261</paragraph><paragraph>For information about NORDITROPIN<sup>&#xAE;</sup></paragraph><paragraph>Visit: norditropin.com</paragraph><paragraph>Or call: 1 (888) 668-6444</paragraph><paragraph>Revised: 01/2025</paragraph><paragraph>&#xA9; 2025 Novo Nordisk A/S</paragraph></td></tr></tbody></table>","<table width=\"100%\"><col width=\"50%\"/><col width=\"50%\"/><tbody><tr><td align=\"center\" colspan=\"2\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><renderMultiMedia ID=\"id-10913472\" referencedObject=\"A1408843-FCCC-4E5F-A40B-47C66C0878F9\"/></td></tr><tr><td align=\"center\" colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-2071269716\" referencedObject=\"A554CB5C-E6F5-4735-9F2F-40ED4E6E17BF\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Norditropin FlexPro Pen is for single-patient-use only.</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Supplies you will need:</content></paragraph><list listType=\"unordered\"><item><caption>&#x2022;</caption>Norditropin FlexPro prefilled Pen new injection needle. Norditropin prefilled Pen is designed to be used with all Novo Nordisk disposable needles up to a length of 8 mm</item><item><caption>&#x2022;</caption>sharps disposal container. See step 5 for information on how to throw away (dispose of) used needles and Pens.</item><item><caption>&#x2022;</caption>alcohol pad</item><item><caption>&#x2022;</caption>gauze pad</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id215639427\" referencedObject=\"ID_8cfda2f3-696d-49c5-9860-c0205aed594f\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">How to use your Norditropin FlexPro Pen</content></paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">5 steps you should follow for a Norditropin injection:</content></paragraph><list listType=\"unordered\"><item><caption> </caption>Step 1: Prepare your Norditropin FlexPro Pen </item><item><caption> </caption>Step 2: Check the Norditropin flow with each new Pen </item><item><caption> </caption>Step 3: Select your dose</item><item><caption> </caption>Step 4: Inject your dose</item><item><caption> </caption>Step 5: After your injection</item></list><paragraph><content styleCode=\"bold\">For further information about your Pen see:</content></paragraph><list listType=\"unordered\"><item><caption> </caption>Frequently Asked Questions</item><item><caption> </caption>Important information</item><item><caption> </caption>Patient Information</item></list><paragraph><content styleCode=\"bold\">&#xA71D;Important information</content></paragraph><list listType=\"unordered\"><item><caption> </caption>Make sure that you read this information carefully.</item></list><paragraph><content styleCode=\"bold\">&#xA71F;Additional information</content></paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Norditropin is for use under the skin only (subcutaneous). </paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Do not</content> share your Norditropin Pen and needles with another person. You may give another person an infection or get an infection from them. </paragraph><paragraph><content styleCode=\"bold\">Do not use your Pen without proper training from your healthcare provider</content>. </paragraph><paragraph>Make sure that you are confident in giving an injection with the Pen before you start your treatment. </paragraph><paragraph>If you are blind or have poor eyesight and cannot read the dose counter on the Pen, do not use this Pen without help. Get help from a person with good eyesight who is trained to use the Pen.</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Step 1. Prepare your Norditropin FlexPro Pen</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Wash your hands with soap and water.</item><item><caption>&#x2022;</caption><content styleCode=\"bold\">Check the name, strength, and colored label </content>on your Pen to make sure that it contains Norditropin in the right strength.</item><item><caption>&#x2022;</caption>Pull off the Pen cap.</item><item><caption>&#x2022;</caption>Turn the Pen upside down 1 or 2 times to check that the Norditropin in your Pen is clear and colorless.</item><item><caption> </caption>See figure A. <content styleCode=\"bold\">If the Norditropin looks cloudy, do not use the Pen.</content></item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-1201469679\" referencedObject=\"E597A5EE-C141-47FB-933F-CD3001792632\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>When you are ready to give your injection, take a new disposable needle, and remove the paper tab.</item><item><caption>&#x2022;</caption>Push the needle straight onto the Pen. Turn the needle clockwise <content styleCode=\"bold\">until it is on tight</content>. See figure B.</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-1015065117\" referencedObject=\"AAE66295-D44F-4D84-AC79-48E9304F6769\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">&#xA71D;Always use a new needle for each injection.</content> This reduces the risk of contamination, infection, leakage of Norditropin, and blocked needles leading to incorrect dosing.</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Pull off the outer needle cap and <content styleCode=\"bold\">dispose of it</content>. See figure C.</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id1246610432\" referencedObject=\"AA021706-BCE9-4BE1-8FFF-7E98D52422C4\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Pull off the inner needle cap and dispose of it. See figure D.</item></list><paragraph>&#xA71F;A drop of Norditropin may appear at the needle tip. This is normal, but you must still check the Norditropin flow with each new Pen. See step 2.</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-1091923965\" referencedObject=\"ED062850-7636-406E-9146-AC3282B8962D\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">&#xA71D;Never use a bent or damaged needle.</content></paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Step 2. Check the Norditropin flow with each new Pen</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">&#xA71F;If your Pen is already in use</content>, go to step 3.</paragraph><list listType=\"unordered\"><item><caption> </caption><content styleCode=\"bold\">Before using a new Pen</content>, check the Norditropin flow to make sure the growth hormone can flow through the Pen and needle.</item></list><list listType=\"ordered\"><item><caption>1.</caption>Turn the dose selector clockwise 1 tick marking on the dose counter to select 0.1 mg. You will hear a faint &#x201C;click&#x201D; when you turn the dose selector. See figure E.</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id2017883406\" referencedObject=\"F9B71DCE-80BE-40A2-9C14-7CE8D57E58A1\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption><content styleCode=\"bold\">1 marking on the dose counter equals 0.1 mg</content>. See figure F.</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id1668361742\" referencedObject=\"ID_210df554-93ec-46dc-ae53-434f8a898813\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Hold the Pen with the needle pointing up. Press and hold in the dose button until the dose counter returns to &#x201C;0&#x201D;. <content styleCode=\"bold\">The &#x201C;0&#x201D; must line up with the dose pointer</content>. See figure G.</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id845368041\" referencedObject=\"ID_1986bad1-cad8-43e8-903e-f0427fa03728\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Check that a drop of Norditropin appears at the needle tip. See figure H.</item></list><paragraph><content styleCode=\"bold\">&#xA71F;If no Norditropin appears</content>, repeat step 2 up to 6 times.</paragraph><paragraph>If you still do not see a drop of Norditropin, <content styleCode=\"bold\">change the needle:</content></paragraph><list listType=\"unordered\"><item><caption>&#x2022;</caption>Carefully remove the needle from the Pen by turning the needle counterclockwise. Place the needle in a sharps disposal container immediately. See step 5.</item><item><caption>&#x2022;</caption>and repeat step 2 again.</item><item><caption> </caption><content styleCode=\"bold\">Do not use the Pen if a drop of Norditropin still does not appear after changing the needle and repeating step 2. Call Novo Nordisk at </content></item><item><caption> </caption><content styleCode=\"bold\">1-888-668-6444 for help.</content></item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-482464315\" referencedObject=\"D2F34269-7045-4A22-A6F1-6EDFE9FEAE6D\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Step 3. Select your dose</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>To start, check that the dose pointer is set at <content styleCode=\"bold\">&#x201C;0&#x201D;.</content></item><item><caption>&#x2022;</caption>Turn the dose selector clockwise to select the dose you need. See figure I.</item><item><caption> </caption>When you have selected your dose, you can go to step 4.</item></list><paragraph>&#xA71F;I<content styleCode=\"bold\">f there is not enough Norditropin left </content>to select a full dose, see <content styleCode=\"bold\">Frequently Asked Questions</content><content styleCode=\"italics\">.</content></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-1989699225\" referencedObject=\"ID_10771f38-792c-44be-860e-ca2ada106244\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>&#xA71F;The dose counter shows the dose in &#x201C;mg&#x201D;. See figures J and K. Always use the dose counter to select the exact dose<content styleCode=\"bold\">. Do not use the &#x201C;click&#x201D; sounds you hear when you turn the dose selector or the Pen scale to select your dose. Only the dose pointer on the dose counter will show the exact dose selected.</content></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id2060130231\" referencedObject=\"ID_917b8b85-8499-4388-a93b-90d5c6451a86\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"/><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id506325649\" referencedObject=\"E1C3F9A5-2F0A-45D3-AC06-5A37B21A8226\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>&#xA71F;If you select the wrong dose, you can turn the dose selector clockwise or counterclockwise to the correct dose. See figure L.</paragraph><list listType=\"unordered\"><item><caption> </caption>The Pen &#x201C;clicks&#x201D; sound and feel differently when the dose selector is turned clockwise, counterclockwise, or if you forcefully move it past the number of &#x201C;mg&#x201D; left in the Pen.</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id647861705\" referencedObject=\"AB5F69C9-7B0D-4248-8863-71CB6CA7B22A\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Step 4. Inject your dose</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Select the injection site.</item><item><caption>&#x2022;</caption>Norditropin can be injected under the skin (subcutaneously) of your stomach area (abdomen), buttocks, upper legs (thighs), or upper arms, as instructed by your healthcare provider. Change the injection site every day.</item><item><caption>&#x2022;</caption>Wipe the injection site with an alcohol swab and let the area dry.</item><item><caption>&#x2022;</caption>Insert the needle into your skin as your healthcare provider has shown you. See figure M.</item><item><caption> </caption>Make sure you can see the dose counter. <content styleCode=\"bold\">Do not cover it with your fingers</content>. This could block the injection.</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-1669398985\" referencedObject=\"FEC3C65E-C4E7-46AA-B50C-9ED9C3797FEE\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Press and hold down the dose button until the dose counter shows &#x201C;0&#x201D;. See figure N. <content styleCode=\"bold\">The &#x201C;0&#x201D; must line up with the dose pointer</content>. You may then hear or feel a &#x201C;click&#x201D;.</item><item><caption>&#x2022;</caption><content styleCode=\"bold\">Continue to hold the needle in your skin.</content></item></list><paragraph>&#xA71F;If &#x201C;0&#x201D; does not appear in the dose counter after continuously pressing the dose button, your needle may be blocked or damaged, see <content styleCode=\"bold\">Frequently Asked Questions</content>.</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-92021422\" referencedObject=\"ID_3666b6f3-e997-40b4-9c79-8780ef359bc1\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption><content styleCode=\"bold\">Keep the needle in your skin</content> after the dose counter has returned to &#x201C;0&#x201D;. <content styleCode=\"bold\">Count slowly to 6</content> to ensure that the full dose has been delivered. See figure O.</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id656958973\" referencedObject=\"ID_0df083fc-e1d9-4a09-8c41-602dc992f49a\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Carefully remove the needle from your skin. See figure P. If blood appears at the injection site, press lightly with a gauze pad. Do not rub the area.</item></list><paragraph>&#xA71F;You may see a drop of Norditropin at the needle tip after injecting. This is normal and does not affect your dose.</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-891878015\" referencedObject=\"ID_8eb9f83b-eb7f-4288-8895-8f0241c87e7d\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Step 5. After your injection</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Carefully remove the needle from the Pen by turning the needle counterclockwise. See figure Q.</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-2013827780\" referencedObject=\"ABEC9238-A986-4AEE-A750-C3783092CCD3\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Place the needle in a sharps disposal container immediately to reduce the risk of a needle stick. See figure R.</item></list><paragraph>&#xA71F;Always dispose of the needle after each injection.</paragraph><list listType=\"unordered\"><item><caption> </caption>For further information about safe sharps disposal, see <content styleCode=\"bold\">Frequently Asked Questions</content>.</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-1236318319\" referencedObject=\"D21F926D-1ADB-4096-89A8-BFECBB8BC25C\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">&#xA71D;Do not try to put the needle cap back on</content>. You may stick yourself with the needle.</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Put the Pen cap on your Pen after each use to protect the Norditropin from direct light. See figure S.</item><item><caption> </caption>See <content styleCode=\"bold\">&#x201C;How should I store Norditropin?&#x201D;.</content></item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-417178495\" referencedObject=\"ID_7efed8b5-5371-4dcb-9412-c1b850233046\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>&#xA71F;Always remove the needle from your Pen. This reduces the risk of contamination, infection, leakage of Norditropin, and blocked needles leading to incorrect dosing.</paragraph><list listType=\"unordered\"><item><caption> </caption><content styleCode=\"bold\">How should I store Norditropin?</content></item><item><caption> </caption>&#x2022;<content styleCode=\"bold\">Before you use Norditropin FlexPro pens for the first time: </content></item></list><list listType=\"ordered\"><item><caption>1.</caption>Store your new, unused <content styleCode=\"bold\">Norditropin</content> pen in a refrigerator between 36&#xBA;F to 46&#xBA;F (2&#xBA;C to 8&#xBA;C). </item><item><caption>2.</caption>Do not freeze <content styleCode=\"bold\">Norditropin</content>. </item><item><caption>3.</caption>When stored in the refrigerator, do not store <content styleCode=\"bold\">Norditropin</content> directly next to the cooling element.</item><item><caption>4.</caption>Keep <content styleCode=\"bold\">Norditropin</content> away from direct light.</item><item><caption>5.</caption>Do not use <content styleCode=\"bold\">Norditropin</content> that has been frozen or in temperatures warmer than 77&#xBA;F (25&#xBA;C).</item><item><caption>6.</caption>Do not use <content styleCode=\"bold\">Norditropin</content> after the expiration date printed on the carton and the pen.</item><item><caption> </caption>&#x2022;<content styleCode=\"bold\">After you use Norditropin FlexPro pens and there is still medicine left: </content></item><item><caption>7.</caption>Store remaining <content styleCode=\"bold\">Norditropin</content> in the refrigerator between 36&#xBA;F to 46&#xBA;F (2&#xBA;C to 8&#xBA;C) and use within 4 weeks, or </item><item><caption>8.</caption>Store remaining <content styleCode=\"bold\">Norditropin</content> at room temperature no warmer than 77&#xBA;F (25&#xBA;C) and use within 3 weeks.</item><item><caption> </caption><content styleCode=\"bold\">Keep Norditropin and all medicines out of the reach of children.</content></item></list></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Frequently Asked Questions</content></paragraph><paragraph><content styleCode=\"bold\">How do I see how </content></paragraph><paragraph><content styleCode=\"bold\">much Norditropin is </content></paragraph><list listType=\"unordered\"><item><caption> </caption><content styleCode=\"bold\">left in my Pen?</content></item></list></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>The Pen scale shows you approximately how much Norditropin is left in your Pen. See figure T.</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-1719657317\" referencedObject=\"ID_77000a4a-c4c0-4236-8aff-9fa6925618f5\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>To see how much Norditropin is left in your Pen, use the dose counter: Turn the dose selector clockwise until the dose counter stops. The dose pointer will line up with the number of &#x201C;mg&#x201D; left in the Pen. You can select a maximum dose of 8.0 mg. If the dose counter stops with the dose pointer lined up with &#x201C;8.0&#x201D;, at least 8.0 mg are left in your Pen. </paragraph><paragraph>If the dose counter stops with the dose pointer lined up with &#x201C;3.8&#x201D;, only 3.8 mg are left in your Pen. See figure U.</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-1174331466\" referencedObject=\"ID_347b7d57-de9b-45d0-b6d8-9bea59139dd7\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">What if I need a larger dose than what is left in my Pen? </content></paragraph><paragraph>It is not possible to select a larger dose on the dose counter than the number of &#x201C;mg&#x201D; left in your Pen.</paragraph><paragraph>If you need more Norditropin than you have left in your Pen, you can use a new Pen or split your dose between your current Pen and a new Pen. <content styleCode=\"bold\">Only split your dose if you have been trained or advised by your healthcare provider on how to do this. </content>You may find it helpful to use a calculator to plan the doses as instructed by your healthcare provider.</paragraph><paragraph><content styleCode=\"bold\">Be very careful to calculate your split dose correctly so that you do not give the wrong dose</content>. If you are not sure how to split your dose using two Pens, then select and inject the dose you need with a new Pen.</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">What if no Norditropin appears when I check the flow?</content></paragraph><paragraph><content styleCode=\"bold\">A. Your needle may be blocked or damaged</content>, if no Norditropin appears at the needle tip. Remove the needle as described in step 5 and repeat steps 1 and 2.</paragraph><paragraph><content styleCode=\"bold\">B. Your Pen may be defective</content>, if Norditropin still does not appear after changing the needle. Do not use the Pen. Contact Novo Nordisk at 1-888-668-6444. </paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">What if &#x201C;0&#x201D; does not appear after completing my injection?</content></paragraph><paragraph>The needle may be blocked or damaged, and <content styleCode=\"bold\">you have not received any Norditropin</content> &#x2013; even though the dose counter has moved from the dose that you have set. Remove the needle as described in step 5 and repeat steps 1 to 4.</paragraph><paragraph>If &#x201C;0&#x201D; still does not appear after completing the injection, contact Novo Nordisk at 1-888-668-6444.</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">How should I take care of my Pen?</content></paragraph><paragraph>Be careful not to drop your Pen or knock it against hard surfaces. Do not expose your Pen to dust, dirt, liquid, or direct light.</paragraph><paragraph>See &#x201C;<content styleCode=\"bold\">How should I store Norditropin?&#x201D;. </content></paragraph><paragraph>Do not try to refill your Pen, it is already prefilled. When your Pen is empty, throw it away and use a new pen. See <content styleCode=\"bold\">&#x201C;How do I dispose of used needles and Pens?</content>&#x201D;.</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Frequently Asked Questions</content></paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">What if I drop my Pen?</content></paragraph><paragraph>If you drop your Pen or think that something is wrong with it, attach a new disposable needle and check the Norditropin flow before you inject, see steps 1 and 2. Do not try to repair your Pen or pull it apart.</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">How do I clean my Pen?</content></paragraph><paragraph>Do not wash, soak, or lubricate your Pen. If necessary, clean it with mild detergent on a moistened cloth.</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">How do I dispose of used needles and Pens?</content></paragraph><paragraph>Put your used needles in an FDA-cleared sharps disposal container right away after use. <content styleCode=\"bold\">Do not throw away (dispose of) loose needles in your household trash</content>. If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:</paragraph><list listType=\"ordered\"><item><caption> </caption>&#x2022; made of a heavy-duty plastic, </item><item><caption> </caption>&#x2022; can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, </item><item><caption> </caption>&#x2022; upright and stable during use, </item><item><caption> </caption>&#x2022; leak-resistant, and </item><item><caption> </caption>&#x2022; properly labeled to warn of hazardous waste inside the container.</item></list><paragraph>When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should dispose of used needles and Pens. For more information about safe sharps disposal, and for specific information about safe sharps disposal in the state that you live in, go to the FDA&#x2019;s website at: <linkHtml href=\"http://www.fda.gov/safesharpsdisposal\">http://www.fda.gov/safesharpsdisposal</linkHtml>.</paragraph><paragraph>Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this.</paragraph><paragraph>Do not recycle your used sharps disposal container.</paragraph><paragraph>When there is not enough medicine left in your Pen for your prescribed dose, the Pen may be thrown away in your household trash after you have removed the needle.</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">&#xA71F;Important information</content></paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>Caregivers must <content styleCode=\"bold\">be very careful when handling needles</content> to reduce the risk of needle sticks and infection.</item><item><caption>&#x2022;</caption>Norditropin<sup>&#xAE;</sup> FlexPro<sup>&#xAE;</sup> 30 mg/3 mL Pen <content styleCode=\"bold\">is not compatible with FlexPro<sup>&#xAE;</sup> PenMate<sup>&#xAE;</sup>.</content></item></list></td></tr><tr><td align=\"center\" colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-1464492750\" referencedObject=\"ID_8edadea7-cc3d-413b-afdb-7d7b57c3e5dc\"/><paragraph>www.norditropin.com</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>This Instructions for Use has been approved by the U.S. Food and Drug Administration.</paragraph><paragraph><content styleCode=\"italics\">Norditropin</content><sup>&#xAE;</sup> and <content styleCode=\"italics\">FlexPro</content><content styleCode=\"bold\"><sup>&#xAE;</sup></content> are registered trademarks of Novo Nordisk Health Care AG.</paragraph><paragraph><content styleCode=\"italics\">Novo Nordisk</content><content styleCode=\"bold\"><sup>&#xAE;</sup></content> and <content styleCode=\"italics\">PenMate</content><content styleCode=\"bold\"><sup>&#xAE; </sup></content>are registered trademarks of Novo Nordisk A/S.</paragraph><paragraph>PATENT Information: <linkHtml href=\"http://novonordisk-us.com/products/product-patents.html\">http://novonordisk-us.com/products/product-patents.html</linkHtml></paragraph><paragraph>Manufactured by:</paragraph><paragraph>Novo Nordisk Inc.</paragraph><paragraph>800 Scudders Mill Road</paragraph><paragraph>Plainsboro, NJ 08536 </paragraph><paragraph>U.S. License No. 1261</paragraph><paragraph>For information about NORDITROPIN<sup>&#xAE;</sup></paragraph><paragraph>Visit: norditropin.com</paragraph><paragraph>Or call: 1 (888) 668-6444</paragraph><paragraph>Revised: 01/2025</paragraph><paragraph>&#xA9; 2025 Novo Nordisk A/S</paragraph></td></tr></tbody></table>","<table width=\"100%\"><col width=\"50%\"/><col width=\"50%\"/><tbody><tr><td colspan=\"2\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>Read this Instructions for Use before you start using your Pen with PenMate.</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>PenMate hides the needle when you inject your Norditropin growth hormone with Norditropin FlexPro 5 mg/1.5 mL, 10 mg/1.5 mL, and 15 mg/1.5 mL Pens <content styleCode=\"bold\">or</content> Sogroya growth hormone with Sogroya 5 mg/1.5 mL, 10 mg/1.5 mL, and 15 mg/1.5 mL Pens, so that you cannot see the needle. </item><item><caption>&#x2022;</caption>Use your PenMate only after you have been trained by a healthcare provider. </item><item><caption>&#x2022;</caption>People who are blind or have poor eyesight should only use the PenMate and Pen with help from a person with good eyesight who is trained to use the PenMate and Pen.</item><item><caption> </caption></item><item><caption>&#x2022;</caption>The figures in this Instructions for Use show PenMate being used with a Norditropin FlexPro 5 mg/1.5 mL Pen and a NovoFine needle that is <content styleCode=\"bold\">8 mm</content> long. Even if you are using a Norditropin FlexPro 10 mg/1.5 mL or 15 mg/1.5 mL Pen or a Sogroya 5 mg/1.5 mL, 10 mg/1.5 mL, or 15 mg/1.5 mL Pen or a different needle that is <content styleCode=\"bold\">8 mm</content> long, the instructions are the same. </item><item><caption>&#x2022;</caption><content styleCode=\"bold\">Do not </content>share your Norditropin FlexPro or Sogroya Pens and needles with another person. You may give another person an infection or get an infection from them.</item></list></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Supplies you will need to use your Pen with PenMate: </content></paragraph><list listType=\"unordered\"><item><caption>&#x2022;</caption>1 PenMate. <content styleCode=\"bold\">See Figure A.</content></item><item><caption>&#x2022;</caption>1 Norditropin FlexPro Pen or Sogroya Pen. <content styleCode=\"bold\">See Figure B.</content> PenMate does not work with other injection devices.</item><item><caption>&#x2022;</caption>1 disposable needle up to <content styleCode=\"bold\">8 mm </content>long<content styleCode=\"bold\">.See FigureC.</content> Needles are not included with your PenMate or Pen. </item><item><caption>&#x2022;</caption>2 alcohol swabs. <content styleCode=\"bold\">See Figure C.</content></item><item><caption>&#x2022;</caption>a sharps disposal container. <content styleCode=\"bold\">See Figure C. </content>See <content styleCode=\"bold\">&#x201C;How should I dispose of my Pen and needles&#x201D;</content> at the end of these instructions for information on how to throw away (dispose of) used Pens and needles.</item></list></td></tr><tr><td align=\"center\" colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id420459265\" referencedObject=\"ID_9ec2241e-766d-42b9-b1df-c2b08fad85d0\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Pen:</content></paragraph><paragraph>This pen represents Norditropin FlexPro 5 mg/1.5 mL, 10 mg/1.5 mL or 15 mg/1.5 mL Pen and Sogroya 5 mg/1.5 mL, 10 mg/1.5 mL, and 15 mg/1.5 mL Pen </paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-897818757\" referencedObject=\"ID_39e68457-b2bb-4725-aa79-9359d4da196f\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Needle parts and supplies:</content></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-478309249\" referencedObject=\"ID_4f05722b-ebda-4e2f-9f0e-443805a3c01b\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Pen case</content></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id813919139\" referencedObject=\"ID_0aaa4131-a6b3-494c-bbb0-9f79564bdef6\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Step 1: Preparing your PenwithPenMate:</content></paragraph><paragraph>Wash your hands with soap and water and dry them. Check the name and the colored label on your Pen to make sure it contains the growth hormone strength prescribed by your healthcare provider.</paragraph><paragraph>Pull off the PenMate cap. </paragraph><paragraph><content styleCode=\"bold\">See Figure E.</content></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-1501338527\" referencedObject=\"ID_1bbe60ac-3c3a-440c-a99d-abbfc3eba76b\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption> </caption>Pull off the Pen cap and throw it away. </item><item><caption> </caption><content styleCode=\"bold\">See Figure F. </content></item></list><paragraph>You will not need the Pen cap with your PenMate.</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id2004005822\" referencedObject=\"ID_3a69bc30-8ffd-450e-a29e-d9a2c83a1ed5\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Look in the Pen window. Check the liquid medicine in your Pen by turning it upside down 1 or 2 times. </paragraph><paragraph><content styleCode=\"bold\">See Figure G.</content></paragraph><list listType=\"unordered\"><item><caption>&#x2022;</caption><content styleCode=\"bold\">Norditropin FlexPro Pen</content>: the liquid in the Norditropin FlexPro Pen should be clear and colorless. <content styleCode=\"bold\">If the liquid looks cloudy or you see particles, do not use the Norditropin FlexPro Pen</content>.</item><item><caption>&#x2022;</caption><content styleCode=\"bold\">Sogroya Pen</content>: the liquid in the Sogroya Pen should be clear to almost clear and colorless to slightly yellow. <content styleCode=\"bold\">If the liquid looks cloudy or you see particles, do not use the Sogroya Pen</content>.</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id1991204896\" referencedObject=\"ID_68a70421-f14e-4b40-bc1e-d44705524bc1\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption> </caption>Wipe the front stopper on the needle thread of the Pen with an alcohol swab. </item><item><caption> </caption><content styleCode=\"bold\">See Figure H.</content></item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-110904245\" referencedObject=\"A0B96B79-0C9F-4A35-9768-BF9258E0A1E5\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption> </caption>Insert the Pen into the PenMate. Twist the Pen clockwise until you hear or feel a click. </item><item><caption> </caption><content styleCode=\"bold\">See Figure I.</content></item></list><paragraph>The Pen is correctly attached in your PenMate when the display window on the Pen lines up with the insertion button on your PenMate.</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-370152431\" referencedObject=\"ID_0e4d3633-41f0-4f09-a717-d264a27b2b97\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Step 2. Attaching the needle to your Pen:</content></paragraph><list listType=\"unordered\"><item><caption>&#x2022;</caption><content styleCode=\"bold\">Do not</content> place a needle on your Pen until you are ready to give an injection.</item><item><caption>&#x2022;</caption>Always use a new needle for each injection.</item><item><caption>&#x2022;</caption><content styleCode=\"bold\">Do not</content> use a bent or damaged needle.</item></list><paragraph>Get a new disposable needle and tear off the paper tab. </paragraph><paragraph><content styleCode=\"bold\">See Figure J.</content></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id822702701\" referencedObject=\"B4F19F7F-67EE-4C51-B2BD-2BB768577487\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Holding the Pen with 1 hand, firmly press the needle onto the needle thread of the Pen. Screw the needle in a clockwise direction until the needle will not turn anymore. </paragraph><paragraph><content styleCode=\"bold\">See Figure K.</content></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id1451661160\" referencedObject=\"ID_83b904ea-f853-432b-a2b4-5227d73f8522\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Pull off the outer needle cap and save it. </paragraph><paragraph><content styleCode=\"bold\">See Figure L. </content></paragraph><paragraph>You will need the outer needle cap after the injection so you can safely remove the needle from the Pen.</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-1475908680\" referencedObject=\"ID_595fe6d9-1bc2-4d00-9b3e-2554da564c79\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption> </caption>Pull off the inner needle cap and throw it away. </item><item><caption> </caption><content styleCode=\"bold\">See Figure M.</content></item></list><paragraph>A drop of liquid may appear at the needle tip. This is normal. </paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-1523469356\" referencedObject=\"ID_0bbe7c1b-0c51-4754-947f-9aa408c81fa0\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Step 3. Priming a new Pen:</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Checking the growth hormone flow in the Pen (priming) is not needed for a Pen you have used before. </content></paragraph><paragraph><content styleCode=\"bold\">If the Pen has already been primed, go to Step 4.</content></paragraph><paragraph>Before you use a new Pen you must prepare it for use. Hold the Pen with 1 hand and turn the dose selector clockwise 1 marking to select the <content styleCode=\"bold\">minimumdose.</content></paragraph><paragraph><content styleCode=\"bold\">See Figure N.</content></paragraph><paragraph>You may hear or feel a click when you turn the dose selector.</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id928547409\" referencedObject=\"ID_458426fd-a971-47e3-a1b0-acf32e29d247\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>When you turn the dose selector 1 marking, you select the smallest amount of</paragraph><paragraph>medicine for a dose.</paragraph><paragraph><content styleCode=\"bold\">See Figure O.</content></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id638303003\" referencedObject=\"BADF6F7C-FAE2-4A6D-A6A8-49CF9113D48C\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>This lowest dose will be used for your Norditropin or Sogroya flow check dose.</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Hold your Pen with PenMate with the needle pointing up. You may see air bubbles in the PenMate window. Gently tap the top of PenMate a few times to let any air bubbles rise to the top. </paragraph><paragraph><content styleCode=\"bold\">See Figure P.</content></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-1891187380\" referencedObject=\"EFE05D14-226F-4166-A16B-6098798AE0A8\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Press the dose button until the dose pointer lines up with the <content styleCode=\"bold\">&#x201C;0&#x201D;</content> in the display window on the Pen and a drop of liquid appears at the needle tip. </paragraph><paragraph><content styleCode=\"bold\">See Figure Q.</content></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id1829093627\" referencedObject=\"ID_70e4fbd1-aa22-4a61-9546-e1cc4c699674\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">If no drop of liquid appears at the needle tip, </content>repeat Step 3 again up to 6 times. </paragraph><paragraph>If there is still no drop of liquid at the needle tip, <content styleCode=\"bold\">change the needle</content> and repeat Step 3 again.</paragraph><paragraph><content styleCode=\"bold\">If a drop of liquid still does not appear at the needle tip after repeating Step 3 and changing the needle, call Novo Nordisk at 1-888-668-6444 for help.</content></paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Step 4. Selecting the correct dose of Norditropin or Sogroya:</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Use the dose selector on your Pen to make sure you have the exact dose selected. Your dose will be in a certain number of mg (milligrams). </paragraph><paragraph>To start, check that the dose pointer on the Pen is set at <content styleCode=\"bold\">&#x201C;0&#x201D;.</content></paragraph><paragraph>Select the dose you need by turning the dose selector clockwise. If you move past your dose, turn the dose selector counterclockwise until the right number of mg lines up with the dose pointer. <content styleCode=\"bold\">See Figure R.</content></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id312379635\" referencedObject=\"C9CAAA1B-5A46-48DF-ADBE-F896221E33E2\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>To guide you, the dose selector click sound is different when turned clockwise (softer click) or counterclockwise (louder click). You will hear a click for every single unit dialed.</paragraph><paragraph>When dialing counterclockwise, be careful not to press the dose button as liquid will come out.</paragraph><paragraph>You can use the growth hormone scale on the side of the Pen to see about how much growth hormone is left in the Pen. You can also use the dose selector to see exactly how much growth hormone is left in the Pen.</paragraph><paragraph>If the Pen contains less than 2 mg, 4 mg, or 8 mg (depending on whether you use a 5 mg/1.5 mL, 10 mg/1.5 mL, or 15 mg/1.5 mL Pen), turn the dose selector until it stops. The number that lines up with the dose pointer shows how many mg are left in the Pen. You cannot set a dose higher than the number of mg left in the Pen.</paragraph><paragraph>If there is not enough Norditropin or Sogroya left in the Pen for your full dose, use a new Norditropin FlexPro Pen or Sogroya Pen to inject the remaining amount of your dose or contact your healthcare provider.</paragraph><paragraph>Remember to subtract the dose already received. For example, if the dose is 0.7 mg and you can only set the dose selector to 0.35 mg, you should inject another 0.35 mg with a new Norditropin FlexPro Pen or Sogroya Pen.</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Important:</content></paragraph><list listType=\"unordered\"><item><caption>&#x2022;</caption><content styleCode=\"bold\">Do not use the Pen clicks to count the number of mg you select. Only the display window and dose pointer will show the exact number.</content></item><item><caption>&#x2022;</caption><content styleCode=\"bold\">Do not use the growth hormone scale to measure how much liquid to inject. Only the display window and dose pointer will show the exact number.</content></item></list></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Step 5. Selecting your injection site and injecting the dose of Norditropin or Sogroya:</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Change your injection site every day. Select the injection site and wipe your skin with an alcohol swab as your healthcare provider showed you. </paragraph><paragraph>Norditropin or Sogroya can be injected under your skin (subcutaneously) of your buttocks, stomach area (abdomen), upper legs (thighs), upper arms, or as instructed by your healthcare provider.</paragraph><paragraph><content styleCode=\"bold\">See Figure S.</content></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id1623267184\" referencedObject=\"FE22FE2E-FD32-485B-AC7F-9D2BF16CE7BA\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Hold onto both the PenMate and your Pen without touching the insertion button on the PenMate <content styleCode=\"bold\">or</content> the dose button on the Pen.</paragraph><paragraph><content styleCode=\"bold\">Do not press the insertion button on the PenMate before you are ready to inject your dose. </content>This lowers the risk of hurting yourself with the needle.</paragraph><paragraph>Hold the PenMate firmly with 1 hand and pull the Pen out with your other hand until you hear and feel a click. <content styleCode=\"bold\">See Figure T.</content></paragraph><paragraph>The needle is now hidden in PenMate.</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-1069813147\" referencedObject=\"BE2EEB25-039A-414B-ADCF-8033E50103C1\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Norditropin and Sogroya is for use under your skin only (subcutaneous). Hold the PenMate against your skin. Press the insertion button on the PenMate until you hear or feel a click. </paragraph><paragraph>When you hear or feel the click, the needle has been inserted automatically into your skin. </paragraph><paragraph><content styleCode=\"bold\">See Figure U.</content></paragraph><paragraph>You are now ready to inject your dose.</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id1361312648\" referencedObject=\"ID_7368886e-2073-4294-8564-1ae3a61a7fd6\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Press the dose button on the Pen to inject your dose.Do not</content> turn the dose button while you are pressing it. If you turn the dose button, you will not inject growth hormone.</paragraph><paragraph>Make sure you can see the display window. <content styleCode=\"bold\">Do not</content> cover it with your fingers.</paragraph><paragraph><content styleCode=\"bold\">Press and hold down the dose button on the Pen until the display window returns to &#x201C;0&#x201D;. </content></paragraph><paragraph>The <content styleCode=\"bold\">&#x201C;0&#x201D;</content> must line up with the dose pointer. You may then hear or feel a firm click.</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">After the display window has returned to &#x201C;0&#x201D;, leave the needle under your skin for at least 6 seconds </content>to make sure you get your full dose. </paragraph><paragraph><content styleCode=\"bold\">See Figure V.</content></paragraph><paragraph><content styleCode=\"bold\">Let go of the dose button while you wait.</content></paragraph><paragraph><content styleCode=\"bold\">See Figure V</content>.</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id2007475590\" referencedObject=\"ID_8b4b6c43-2589-4dc0-8855-e8661f5e0ad0\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">If the dose button cannot be pushed in completely or &#x201C;0&#x201D; does not appear in the display window, you did not receive the full dose. Call Novo Nordisk at 1-888-668-6444 for help. You may need a new Pen.</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Important:</content></paragraph><paragraph><content styleCode=\"bold\">Always press the dose button to inject the dose. Turning the dose selector will not inject the dose.</content></paragraph><paragraph><content styleCode=\"bold\">Do not touch the display window when you inject, as this can block the injection.</content></paragraph><paragraph>Carefully lift the Pen to remove the needle from the skin. </paragraph><paragraph><content styleCode=\"bold\">See Figure W.</content></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-871773365\" referencedObject=\"ID_051909a0-867c-4d22-bd91-d0fa60032b0b\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Step 6. What to do after your injection is completed:</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Carefully put the outer needle cap back on the needle. </paragraph><paragraph>Remove the needle from the Pen after each injection. </paragraph><paragraph><content styleCode=\"bold\">See Figure X.</content></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-1981065172\" referencedObject=\"ID_41ab9a4b-e67e-4323-ae3d-2b7fc93974b8\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Unscrew the needle by turning it counterclockwise. Do not touch the needle. Hold the Pen with 1 hand and carefully remove the needle from the Pen with your other hand. </paragraph><paragraph><content styleCode=\"bold\">See Figure Y.</content></paragraph><paragraph>Throw away (dispose of) the needle. See <content styleCode=\"bold\">&#x201C;How should I dispose of my Pen and needles?&#x201D; </content>at the end of these instructions.</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-377171975\" referencedObject=\"ID_47ccc3c0-767b-4bbb-8a06-bec991511e9a\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Put the PenMate cap back on your PenMate after each use to protect the growth hormone from direct light. </paragraph><paragraph><content styleCode=\"bold\">See Figure Z.</content></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id36404804\" referencedObject=\"CC45F240-3793-42D3-9EB2-7FA39AD61294\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Important safety information to remember: </content></paragraph><list listType=\"unordered\"><item><caption>&#x2022;</caption>Be careful not to drop your PenMate and Pen or knock them against a hard surface. If this happens you will need to check the growth hormone flow. </item><item><caption>&#x2022;</caption><content styleCode=\"bold\">Do not</content> try to put the inner needle cap back on the needle. You may stick yourself with the needle. Be careful when handling used needles to avoid needle stick injuries.</item><item><caption>&#x2022;</caption>After each use always remove and throw away (dispose of) the needle from your Pen. </item><item><caption>&#x2022;</caption><content styleCode=\"bold\">Do not</content> share your Pen or needles with other people.</item><item><caption>&#x2022;</caption>If your PenMate is damaged or lost, you can still use your Pen without your PenMate.</item><item><caption>&#x2022;</caption>Always keep your Pen and needles out of reach of others, especially children.</item></list></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">How should I replace an empty Pen?</content></paragraph><paragraph><content styleCode=\"bold\">PenMate is reusable </content>and should not be thrown away (disposed of). Reuse your PenMate by replacing your Pen when it is empty.</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>When your Pen is empty, <content styleCode=\"bold\">twist the Pen </content>counterclockwise until you hear or feel a click. </paragraph><paragraph><content styleCode=\"bold\">See Figure AA.</content></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id513342774\" referencedObject=\"ID_162753b6-747f-48e5-be8f-0d782e6cdf05\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Gently pull the Pen out of PenMate.</paragraph><paragraph><content styleCode=\"bold\">See Figure BB.</content></paragraph><paragraph>Before throwing away (disposing of) your empty Pen, make sure the needle has been removed. See <content styleCode=\"bold\">&#x201C;How should I dispose of my Pen and needles?&#x201D;</content> at the end of these instructions.</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id1089190729\" referencedObject=\"ID_09b52d73-c476-4cd5-8fe7-c66bc1cb9034\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Insert the new Pen into your PenMate. </paragraph><paragraph><content styleCode=\"bold\">See Figure CC.</content></paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-1082514785\" referencedObject=\"CFE038CE-16BD-4DC6-887C-AA28E78B9093\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Twist the Pen clockwise until you hear or feel a click. </paragraph><paragraph><content styleCode=\"bold\">See Figure DD.</content></paragraph><paragraph>The Pen is correctly attached in your PenMate when the display window on the Pen lines up with the insertion button on your PenMate.</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id505181497\" referencedObject=\"ID_0c2aa763-2a0b-4616-9572-7805a148e2d5\"/></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">How should I store my PenMate and Pen?</content></paragraph><list listType=\"unordered\"><item><caption>&#x2022;</caption>Do not expose your PenMate or Pen to dust, dirt, liquid, or direct light.</item><item><caption>&#x2022;</caption>Store your PenMate and Pen in their case. See <content styleCode=\"bold\">Figure D</content> at the beginning of these instructions.</item><item><caption>&#x2022;</caption>When your Pen is inserted in PenMate, store it as described in the Patient Information leaflet that comes with your Pen.</item></list></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">How should I care for and clean my Pen with PenMate?</content></paragraph><list listType=\"unordered\"><item><caption>&#x2022;</caption><content styleCode=\"bold\">Do not</content> try to refill your Pen. It is prefilled.</item><item><caption>&#x2022;</caption><content styleCode=\"bold\">Do not</content> try to repair your PenMate or your Pen.</item><item><caption>&#x2022;</caption>Only clean your PenMate or Pen with a mild detergent on a moistened cloth.</item><item><caption>&#x2022;</caption><content styleCode=\"bold\">Do not</content> wash, soak, or lubricate your PenMate or Pen. Do not use products containing bleaching agents, such as chlorine, iodine, or alcohol to clean your PenMate or Pen. These products may damage them.</item><item><caption>&#x2022;</caption>If there is liquid growth hormone on the outside of your PenMate or Pen, clean it with a mild detergent on a moistened cloth <content styleCode=\"bold\">before it dries up.</content></item></list></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">How should I throw away (dispose of) my Pen and needles? </content></paragraph><list listType=\"unordered\"><item><caption>&#x2022;</caption>Put your used needles and Pens in a FDA-cleared sharps disposal container right away after use. <content styleCode=\"bold\">Do not throw away (dispose of) loose needles and Pens in your household trash.</content></item><item><caption>&#x2022;</caption>If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:<list listType=\"unordered\"><item><caption>&#x2022;</caption>made of a heavy-duty plastic,</item><item><caption>&#x2022;</caption>can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,</item><item><caption>&#x2022;</caption>upright and stable during use,</item><item><caption>&#x2022;</caption>leak-resistant, and</item><item><caption>&#x2022;</caption>properly labeled to warn of hazardous waste inside the container.</item></list></item><item><caption>&#x2022;</caption>When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and Pens. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA&#x2019;s website at: http://www.fda.gov/safesharpsdisposal. </item><item><caption>&#x2022;</caption>Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.</item></list></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Need help?</content></paragraph><paragraph>PenMate must only be used according to the instructions provided. The manufacturer cannot be held responsible for any problems with PenMate if these instructions have not been followed.</paragraph><paragraph>If you find that your PenMate or case is defective, make sure to have Novo Nordisk replace it. Call the number below to order a new PenMate or case and arrange return of the defective item for inspection.</paragraph><paragraph>For help or further information, write to:</paragraph><paragraph>Novo Nordisk Inc.</paragraph><paragraph>800 Scudders Mill Road</paragraph><paragraph>Plainsboro, NJ 08536, USA</paragraph><paragraph>Visit norditropin.com or sogroya.com</paragraph><paragraph>Or call: 1-888-668-6444</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>PATENT Information: http://novonordisk-us.com/products/product-patents.html</paragraph><paragraph><content styleCode=\"italics\">Novo Nordisk<sup>&#xAE;</sup>, PenMate<sup>&#xAE; </sup>and NovoFine<sup>&#xAE;</sup> are registered trademarks of Novo Nordisk A/S </content></paragraph><paragraph><content styleCode=\"italics\">Norditropin<sup>&#xAE;</sup>, Sogroya<sup>&#xAE;</sup> and FlexPro<sup>&#xAE;</sup> are registered trademarks of Novo Nordisk Health Care AG.</content></paragraph><paragraph>&#xA9; 2025 Novo Nordisk A/S</paragraph><paragraph>Manufactured by:</paragraph><paragraph>Novo Nordisk A/S</paragraph><paragraph>Novo All&#xE9;</paragraph><paragraph>DK-2880 Bagsvaerd</paragraph><paragraph>Denmark</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>This Instructions for Use has been approved by the U.S. Food and Drug Administration.</paragraph><paragraph>Issued: 01/2025</paragraph></td></tr></tbody></table>"],"spl_patient_package_insert":["Patient Package Insert PATIENT INFORMATION NORDITROPIN ® (nor-dee-tro-pin) (somatropin) injection for subcutaneous use What is NORDITROPIN? NORDITROPIN is a prescription medicine that contains human growth hormone, the same growth hormone made by the human body. NORDITROPIN is given by injection under the skin (subcutaneous) and is used to treat: • children who are not growing because of low or no growth hormone. • children who are short (in stature) and who have Noonan syndrome, Turner syndrome, or were born small (small for gestational age-SGA) and have not caught-up in growth by age 2 to 4 years. • children who have Idiopathic Short Stature (ISS). • children who are not growing who have Prader-Willi syndrome (PWS). • adults who do not make enough growth hormone. Do not use NORDITROPIN if: • you have a critical illness caused by certain types of heart or stomach surgery, trauma or breathing (respiratory) problems. • you are a child with Prader-Willi syndrome who is severely obese or has breathing problems including sleep apnea (briefly stop breathing during sleep). • you have cancer or other tumors. • you are allergic to somatropin or any of the ingredients in NORDITROPIN. See the end of this leaflet for a complete list of ingredients in NORDITROPIN. • your healthcare provider tells you that you have certain types of eye problems caused by diabetes (diabetic retinopathy). • you are a child with closed bone growth plates (epiphyses). Before taking NORDITROPIN, tell your healthcare provider about all of your medical conditions, including if you: • have had heart or stomach surgery, trauma or serious breathing (respiratory) problems. • have had a history of problems breathing while you sleep (sleep apnea). • have or have had cancer or any tumor. • have diabetes. • are pregnant or plan to become pregnant. It is not known if NORDITROPIN will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant. • are breastfeeding or plan to breastfeed. It is not known if NORDITROPIN passes into your breast milk. You and your healthcare provider should decide if you will take NORDITROPIN while you breastfeed. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. NORDITROPIN may affect how other medicines work, and other medicines may affect how NORDITROPIN works. How should I use NORDITROPIN? • Read the detailed Instructions for Use that come with NORDITROPIN. • NORDITROPIN comes in 4 different dosage strengths. Your healthcare provider will prescribe the dose that is right for you. • Your healthcare provider will show you how to inject NORDITROPIN. • Use NORDITROPIN exactly as your healthcare provider tells you to. • NORDITROPIN FlexPro pens are for use by 1 person only. • Do not share your NORDITROPIN pens and needles with another person, even if the needle has been changed. You may give another person an infection or get an infection from them. What are the possible side effects of NORDITROPIN? NORDITROPIN may cause serious side effects, including: • high risk of death in people who have critical illnesses because of heart or stomach surgery, trauma or serious breathing (respiratory) problems. • high risk of sudden death in children with Prader-Willi syndrome who are severely obese or have breathing problems, including sleep apnea. • increased risk of growth of cancer or a tumor that is already present and increased risk of the return of cancer or a tumor in people who were treated with radiation to the brain or head as children and who developed low growth hormone problems. Your or your child’s healthcare provider will need to monitor you or your child for a return of cancer or a tumor. Contact the healthcare provider if you or your child starts to have headaches, or have changes in behavior, changes in vision, or changes in moles, birthmarks, or the color of your skin. • new or worsening high blood sugar (hyperglycemia) or diabetes. Your or your child’s blood sugar may need to be monitored during treatment with NORDITROPIN. • increase in pressure in the skull (intracranial hypertension). If you or your child has headaches, eye problems, nausea or vomiting, contact the healthcare provider. • serious allergic reactions. Get medical help right away if you or your child has the following symptoms: o swelling of your face, lips, mouth, or tongue o trouble breathing o wheezing o severe itching o skin rashes, redness, or swelling o dizziness or fainting o fast heartbeat or pounding in your chest o sweating • your body holding too much fluid (fluid retention) such as swelling in the hands and feet, pain in your joints or muscles or nerve problems that cause pain, burning or tingling in the hands, arms, legs and feet. Fluid retention can happen in adults during treatment with NORDITROPIN. Tell your healthcare provider if you have any of these signs or symptoms of fluid retention. • decrease in a hormone called cortisol. The healthcare provider will do blood tests to check your or your child’s cortisol levels. Tell your or your child’s healthcare provider if you or your child has darkening of the skin, severe fatigue, dizziness, weakness, or weight loss. • decrease in thyroid hormone levels. Decreased thyroid hormone levels may affect how well NORDITROPIN works. The healthcare provider will do blood tests to check your or your child’s thyroid hormone levels. • hip and knee pain or a limp in children (slipped capital femoral epiphysis). This may lead to a serious condition where bone tissue dies due to a lack of blood supply (osteonecrosis). Get medical help for your child right away if your child develops a limp or has hip or knee pain. • worsening of curvature of the spine (scoliosis). • severe and constant abdominal pain. This could be a sign of pancreatitis. Tell your or your child’s healthcare provider if you or your child has any new abdominal pain. • loss of fat and tissue weakness in the area of skin you inject. Talk to your healthcare provider about rotating the areas where you inject NORDITROPIN. • increase in phosphorus, alkaline phosphatase and parathyroid hormone levels in your blood. Your or your child’s healthcare provider will do blood tests to check this. The most common side effects of NORDITROPIN include: • injection site reactions and rashes • headaches These are not all the possible side effects of NORDITROPIN. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Novo Nordisk at 1-888-668-6444. How should I store NORDITROPIN? • Before you use NORDITROPIN FlexPro pens for the first time: o Store your new, unused NORDITROPIN pen in a refrigerator between 36ºF to 46ºF (2ºC to 8ºC). o Do not freeze NORDITROPIN. o When stored in the refrigerator, do not store NORDITROPIN directly next to the cooling element. o Keep NORDITROPIN away from direct light. o Do not use NORDITROPIN that has been frozen or in temperatures warmer than 77ºF (25ºC). o Do not use NORDITROPIN after the expiration date printed on the carton and the pen. • After you use NORDITROPIN FlexPro pens and there is still medicine left: o Store remaining NORDITROPIN in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC) and use within 4 weeks, or o Store remaining NORDITROPIN at room temperature no warmer than 77ºF (25ºC) and use within 3 weeks. Keep NORDITROPIN and all medicines out of the reach of children. General information about the safe and effective use of NORDITROPIN. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use NORDITROPIN for a condition for which it was not prescribed. Do not give NORDITROPIN to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about NORDITROPIN that is written for health professionals. What are the ingredients in NORDITROPIN? Active ingredient: somatropin Inactive ingredients : Histidine, Mannitol, Phenol, Poloxamer 188, Hydrochloric Acid/Sodium Hydroxide (as needed) and Water for Injection Manufactured by: Novo Nordisk Inc. Plainsboro, NJ 08536 U.S. License No. 1261 This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 07/2025"],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary Limited available data with somatropin use in pregnant women are insufficient to determine a drug-associated risk of adverse developmental outcomes. In animal reproduction studies, there was no evidence of fetal or neonatal harm when pregnant rats were administered subcutaneous NORDITROPIN during organogenesis or during lactation at doses approximately 10-times higher than the maximal clinical dose of 0.016 mg/kg, based on body surface area (see Data). The estimated background risk of birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In an embryo-fetal development study, NORDITROPIN was administered via subcutaneous injection to pregnant rats from gestation Day 6 to 17, corresponding with the period of organogenesis. NORDITROPIN did not adversely affect fetal viability or developmental outcomes at maternal doses that were approximately 10-times the clinical dose of 0.016 mg/kg, based on body surface area. In a pre- and post-natal development study in pregnant rats, NORDITROPIN was administered from gestation Day 17 through lactation Day 21 (weaning). No adverse developmental effects were observed in the offspring at doses up to 1.1 mg/kg (approximately 10 times the clinical dose of 0.016 mg/kg, based on body surface area). 8.2 Lactation Risk Summary There is no information regarding the presence of somatropin in human milk. Limited published data indicate that exogenous somatropin does not increase normal breastmilk concentrations of growth hormone. No adverse effects on the breastfed infant have been reported with somatropin. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for NORDITROPIN and any potential adverse effects on the breastfed infant from NORDITROPIN or from the underlying maternal condition. 8.4 Pediatric Use Safety and effectiveness of NORDITROPIN in pediatric patients have been established in growth failure due to inadequate secretion of endogenous growth hormone, short stature associated with Noonan syndrome, short stature associated with Turner syndrome, short stature in children born small for gestational age (SGA) with no catch-up growth by age 2 years to 4 years of age, idiopathic short stature (ISS), and growth failure due to Prader-Willi syndrome (PWS). Growth Failure due to Inadequate Secretion of Endogenous Growth Hormone Safety and effectiveness of NORDITROPIN have been established in pediatric patients with growth failure due to growth hormone deficiency in a multi-center, prospective, randomized, open-label, dose-response study in 111 pediatric patients conducted for a two-year period [see Clinical Studies (14.1) ]. Short Stature Associated with Noonan Syndrome Safety and effectiveness of NORDITROPIN have been established in pediatric patients with Noonan syndrome in a prospective, open-label, randomized, parallel group study in 21 pediatric patients conducted for 2 years [see Clinical Studies (14.2) ]. Short Stature Associated with Turner Syndrome Safety and effectiveness of NORDITROPIN have been established in pediatric patients with short stature associated with Turner syndrome in two randomized, parallel group, open-label, multicenter studies in 87 pediatric patients [see Clinical Studies (14.3) ]. Short Stature in Pediatric Patients Born Small for Gestational Age (SGA) with No Catch-up Growth by Age 2 Years to 4 Years of Age Safety and effectiveness of NORDITROPIN have been established in pediatric patients with short stature born SGA with no catch-up growth in a multi-center, randomized, double-blind, two-arm study to final height in 53 pediatric patients and in a randomized study of 84 prepubertal, non-GHD, Japanese pediatric patients [see Clinical Studies (14.4) ]. Idiopathic Short Stature (ISS) Safety and effectiveness of NORDITROPIN have been established in pediatric patients with ISS based on data from a randomized, open-label clinical study with another somatropin product in 105 pediatric patients [see Clinical Studies (14.5) ]. Growth Failure Due to Prader-Willi Syndrome (PWS) Safety and effectiveness of NORDITROPIN have been established in pediatric patients with growth failure due to Prader-Willi Syndrome based on data from two randomized, open label, controlled clinical trials with another somatropin product in pediatric patients. There have been reports of sudden death after initiating therapy with somatropin in pediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection. Male patients with one or more of these factors may be at greater risk than females. Patients with Prader-Willi syndrome should be evaluated for signs of upper airway obstruction and sleep apnea before initiation of treatment with somatropin. [see Contraindications (4) , Warnings and Precautions (5.2) , Clinical Studies (14.6) ]. 8.5 Geriatric Use The safety and effectiveness of NORDITROPIN in patients aged 65 and over has not been evaluated in clinical studies. Elderly patients may be more sensitive to the action of somatropin, and therefore may be more prone to develop adverse reactions. A lower starting dose and smaller dose increments should be considered for older patients [see Dosage and Administration (2.3) ]."],"spl_patient_package_insert_table":["<table width=\"100%\"><col width=\"100%\"/><tbody><tr><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\">PATIENT INFORMATION </content></paragraph><paragraph>NORDITROPIN<sup>&#xAE;</sup> (nor-dee-tro-pin)</paragraph><paragraph>(somatropin) injection for subcutaneous use</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">What is NORDITROPIN?</content></paragraph><paragraph>NORDITROPIN is a prescription medicine that contains human growth hormone, the same growth hormone made by the human body.</paragraph><paragraph>NORDITROPIN is given by injection under the skin (subcutaneous) and is used to treat:</paragraph><list listType=\"unordered\"><item><caption>&#x2022;</caption>children who are not growing because of low or no growth hormone.</item><item><caption>&#x2022;</caption>children who are short (in stature) and who have Noonan syndrome, Turner syndrome, or were born small (small for gestational age-SGA) and have not caught-up in growth by age 2 to 4 years.</item><item><caption>&#x2022;</caption>children who have Idiopathic Short Stature (ISS).</item><item><caption>&#x2022;</caption>children who are not growing who have Prader-Willi syndrome (PWS).</item><item><caption>&#x2022;</caption>adults who do not make enough growth hormone.</item></list></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Do not use NORDITROPIN if:</content></paragraph><list listType=\"unordered\"><item><caption>&#x2022;</caption>you have a critical illness caused by certain types of heart or stomach surgery, trauma or breathing (respiratory) problems.</item><item><caption>&#x2022;</caption>you are a child with Prader-Willi syndrome who is severely obese or has breathing problems including sleep apnea (briefly stop breathing during sleep). </item><item><caption>&#x2022;</caption>you have cancer or other tumors.</item><item><caption>&#x2022;</caption>you are allergic to somatropin or any of the ingredients in NORDITROPIN. See the end of this leaflet for a complete list of ingredients in NORDITROPIN.</item><item><caption>&#x2022;</caption>your healthcare provider tells you that you have certain types of eye problems caused by diabetes (diabetic retinopathy).</item><item><caption>&#x2022;</caption>you are a child with closed bone growth plates (epiphyses).</item></list></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Before taking NORDITROPIN, tell your healthcare provider about all of your medical conditions, including if you:</content></paragraph><list listType=\"unordered\"><item><caption>&#x2022;</caption>have had heart or stomach surgery, trauma or serious breathing (respiratory) problems. </item><item><caption>&#x2022;</caption>have had a history of problems breathing while you sleep (sleep apnea). </item><item><caption>&#x2022;</caption>have or have had cancer or any tumor.</item><item><caption>&#x2022;</caption>have diabetes.</item><item><caption>&#x2022;</caption>are pregnant or plan to become pregnant. It is not known if NORDITROPIN will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.</item><item><caption>&#x2022;</caption>are breastfeeding or plan to breastfeed. It is not known if NORDITROPIN passes into your breast milk. You and your healthcare provider should decide if you will take NORDITROPIN while you breastfeed. </item></list><paragraph><content styleCode=\"bold\">Tell your healthcare provider about all the medicines you take,</content> including prescription and over-the-counter medicines, vitamins, and herbal supplements. NORDITROPIN may affect how other medicines work, and other medicines may affect how NORDITROPIN works.</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">How should I use NORDITROPIN?</content></paragraph><list listType=\"unordered\"><item><caption>&#x2022;</caption>Read the detailed <content styleCode=\"bold\">Instructions for Use </content>that come with NORDITROPIN.</item><item><caption>&#x2022;</caption>NORDITROPIN comes in 4 different dosage strengths. Your healthcare provider will prescribe the dose that is right for you.</item><item><caption>&#x2022;</caption>Your healthcare provider will show you how to inject NORDITROPIN.</item><item><caption>&#x2022;</caption>Use NORDITROPIN exactly as your healthcare provider tells you to.<list listType=\"unordered\"><item><caption>&#x2022;</caption>NORDITROPIN FlexPro pens are for use by 1 person only.</item><item><caption>&#x2022;</caption><content styleCode=\"bold\">Do not share your NORDITROPIN pens and needles with another person, even if the needle has been changed. You may give another person an infection or get an infection from them.</content></item></list></item></list></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">What are the possible side effects of NORDITROPIN?</content></paragraph><paragraph><content styleCode=\"bold\">NORDITROPIN may cause serious side effects, including: </content></paragraph><list listType=\"unordered\"><item><caption>&#x2022;</caption>high risk of death in people who have critical illnesses because of heart or stomach surgery, trauma or serious breathing (respiratory) problems.</item><item><caption>&#x2022;</caption>high risk of sudden death in children with Prader-Willi syndrome who are severely obese or have breathing problems, including sleep apnea.</item><item><caption>&#x2022;</caption>increased risk of growth of cancer or a tumor that is already present and increased risk of the return of cancer or a tumor in people who were treated with radiation to the brain or head as children and who developed low growth hormone problems. Your or your child&#x2019;s healthcare provider will need to monitor you or your child for a return of cancer or a tumor. Contact the healthcare provider if you or your child starts to have headaches, or have changes in behavior, changes in vision, or changes in moles, birthmarks, or the color of your skin. </item><item><caption>&#x2022;</caption>new or worsening high blood sugar (hyperglycemia) or diabetes. Your or your child&#x2019;s blood sugar may need to be monitored during treatment with NORDITROPIN.</item><item><caption>&#x2022;</caption>increase in pressure in the skull (intracranial hypertension). If you or your child has headaches, eye problems, nausea or vomiting, contact the healthcare provider.</item><item><caption>&#x2022;</caption>serious allergic reactions. Get medical help right away if you or your child has the following symptoms:</item><item><caption>o</caption>swelling of your face, lips, mouth, or tongue </item><item><caption>o</caption>trouble breathing</item><item><caption>o</caption>wheezing</item><item><caption>o</caption>severe itching</item><item><caption>o</caption>skin rashes, redness, or swelling</item><item><caption>o</caption>dizziness or fainting</item><item><caption>o</caption>fast heartbeat or pounding in your chest </item><item><caption>o</caption>sweating</item><item><caption>&#x2022;</caption>your body holding too much fluid (fluid retention) such as swelling in the hands and feet, pain in your joints or muscles or nerve problems that cause pain, burning or tingling in the hands, arms, legs and feet. Fluid retention can happen in adults during treatment with NORDITROPIN. Tell your healthcare provider if you have any of these signs or symptoms of fluid retention.</item><item><caption>&#x2022;</caption>decrease in a hormone called cortisol. The healthcare provider will do blood tests to check your or your child&#x2019;s cortisol levels. Tell your or your child&#x2019;s healthcare provider if you or your child has darkening of the skin, severe fatigue, dizziness, weakness, or weight loss. </item><item><caption>&#x2022;</caption>decrease in thyroid hormone levels. Decreased thyroid hormone levels may affect how well NORDITROPIN works. The healthcare provider will do blood tests to check your or your child&#x2019;s thyroid hormone levels.</item><item><caption>&#x2022;</caption>hip and knee pain or a limp in children (slipped capital femoral epiphysis). This may lead to a serious condition where bone tissue dies due to a lack of blood supply (osteonecrosis). Get medical help for your child right away if your child develops a limp or has hip or knee pain. </item><item><caption>&#x2022;</caption>worsening of curvature of the spine (scoliosis).</item><item><caption>&#x2022;</caption>severe and constant abdominal pain. This could be a sign of pancreatitis. Tell your or your child&#x2019;s healthcare provider if you or your child has any new abdominal pain. </item><item><caption>&#x2022;</caption>loss of fat and tissue weakness in the area of skin you inject. Talk to your healthcare provider about rotating the areas where you inject NORDITROPIN.</item><item><caption>&#x2022;</caption>increase in phosphorus, alkaline phosphatase and parathyroid hormone levels in your blood. Your or your child&#x2019;s healthcare provider will do blood tests to check this.</item></list><paragraph><content styleCode=\"bold\">The most common side effects of NORDITROPIN include:</content></paragraph><list listType=\"unordered\"><item><caption>&#x2022;</caption>injection site reactions and rashes</item><item><caption>&#x2022;</caption>headaches</item></list><paragraph>These are not all the possible side effects of NORDITROPIN.</paragraph><paragraph>Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Novo Nordisk at 1-888-668-6444.</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">How should I store NORDITROPIN?</content></paragraph><list listType=\"unordered\"><item><caption>&#x2022;</caption><content styleCode=\"bold\">Before you use NORDITROPIN FlexPro pens for the first time: </content></item><item><caption>o</caption>Store your new, unused NORDITROPIN pen in a refrigerator between 36&#xBA;F to 46&#xBA;F (2&#xBA;C to 8&#xBA;C). </item><item><caption>o</caption>Do not freeze NORDITROPIN. </item><item><caption>o</caption>When stored in the refrigerator, do not store NORDITROPIN directly next to the cooling element.</item><item><caption>o</caption>Keep NORDITROPIN away from direct light.</item><item><caption>o</caption>Do not use NORDITROPIN that has been frozen or in temperatures warmer than 77&#xBA;F (25&#xBA;C).</item><item><caption>o</caption>Do not use NORDITROPIN after the expiration date printed on the carton and the pen.</item><item><caption>&#x2022;</caption><content styleCode=\"bold\">After you use NORDITROPIN FlexPro pens and there is still medicine left: </content></item><item><caption>o</caption>Store remaining NORDITROPIN in the refrigerator between 36&#xBA;F to 46&#xBA;F (2&#xBA;C to 8&#xBA;C) and use within 4 weeks, or </item><item><caption>o</caption>Store remaining NORDITROPIN at room temperature no warmer than 77&#xBA;F (25&#xBA;C) and use within 3 weeks. </item></list><paragraph><content styleCode=\"bold\">Keep NORDITROPIN and all medicines out of the reach of children.</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">General information about the safe and effective use of NORDITROPIN.</content></paragraph><paragraph>Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use NORDITROPIN for a condition for which it was not prescribed. Do not give NORDITROPIN to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about NORDITROPIN that is written for health professionals.</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">What are the ingredients in NORDITROPIN?</content></paragraph><paragraph><content styleCode=\"bold\">Active ingredient:</content> somatropin </paragraph><paragraph><content styleCode=\"bold\">Inactive ingredients</content>: Histidine, Mannitol, Phenol, Poloxamer 188, Hydrochloric Acid/Sodium Hydroxide (as needed) and Water for Injection</paragraph><paragraph>Manufactured by: Novo Nordisk Inc. Plainsboro, NJ 08536 </paragraph><paragraph>U.S. License No. 1261</paragraph></td></tr></tbody></table>"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - NORDITROPIN FLEXPRO 5 MG/1.5 ML NDC 0169-7704-21 List: 770421 5 mg Norditropin ® FlexPro ® (somatropin) injection 5 mg/1.5 mL Prefilled Pen For subcutaneous use Contains 1 x 1.5 mL single-patient-use prefilled pen Rx only 5mg-carton","PRINCIPAL DISPLAY PANEL - NORDITROPIN FLEXPRO 10 MG/1.5 ML NDC 0169-7705-21 List: 770521 10 mg Norditropin ® FlexPro ® (somatropin) injection 10 mg/1.5 mL Prefilled Pen Contains 1 x 1.5 mL single-patient-use prefilled pen Rx only 10mg-carton","PRINCIPAL DISPLAY PANEL - NORDITROPIN FLEXPRO 15 MG/1.5 ML NDC 0169-7708-21 List: 770821 15 mg Norditropin ® FlexPro ® (somatropin) injection For subcutaneous use Contains 1 x 1.5 mL single-patient-use prefilled pen Rx only 15mg-carton","PRINCIPAL DISPLAY PANEL - NORDITROPIN FLEXPRO 30 MG/3 ML NDC 0169-7703-21 List: 770321 30 mg Norditropin ® 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DRUG","activeIngredients":[{"name":"SOMATROPIN","strength":"10 mg/1.5mL"}],"marketingCategory":"BLA"}],"safety":{"safetySignals":[{"date":"","signal":"DRUG DOSE OMISSION BY DEVICE","source":"FDA FAERS","actionTaken":"16,809 reports"},{"date":"","signal":"DEVICE LEAKAGE","source":"FDA FAERS","actionTaken":"9,680 reports"},{"date":"","signal":"DEVICE BREAKAGE","source":"FDA FAERS","actionTaken":"8,521 reports"},{"date":"","signal":"DEVICE MECHANICAL ISSUE","source":"FDA FAERS","actionTaken":"6,830 reports"},{"date":"","signal":"DEVICE INFORMATION OUTPUT ISSUE","source":"FDA FAERS","actionTaken":"5,687 reports"},{"date":"","signal":"DEVICE ISSUE","source":"FDA FAERS","actionTaken":"5,238 reports"},{"date":"","signal":"WRONG TECHNIQUE IN DEVICE USAGE PROCESS","source":"FDA FAERS","actionTaken":"4,816 reports"},{"date":"","signal":"INJECTION SITE PAIN","source":"FDA FAERS","actionTaken":"3,597 reports"},{"date":"","signal":"POOR QUALITY DEVICE USED","source":"FDA FAERS","actionTaken":"3,199 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acetate, prednisone)","severity":"Moderate","mechanism":"NORDITROPIN inhibits microsomal enzyme 11β-hydroxysteroid dehydrogenase type 1 (11βHSD-1), reducing conversion of cortisone to active cortisol","management":"Patients treated with glucocorticoid replacement for hypoadrenalism may require increase in maintenance or stress doses following initiation of NORDITROPIN","clinicalEffect":"Reduced serum cortisol concentrations; patients on glucocorticoid replacement may develop hypoadrenalism"},{"drug":"Pharmacologic glucocorticoid therapy and supraphysiologic glucocorticoid treatment","severity":"Moderate","mechanism":"Glucocorticoid therapy may attenuate growth-promoting effects of NORDITROPIN","management":"Carefully adjust glucocorticoid replacement dosing in pediatric patients to avoid both hypoadrenalism and inhibitory effect on growth","clinicalEffect":"Inhibitory effect on growth in pediatric patients"},{"drug":"Cytochrome P450-metabolized 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HbA1c","drugRate":"14%","severity":"common","organSystem":""},{"effect":"Eosinophilia","drugRate":"12%","severity":"common","organSystem":""},{"effect":"Hematoma","drugRate":"9%","severity":"common","organSystem":""},{"effect":"Headache","drugRate":"7%","severity":"common","organSystem":""},{"effect":"Hypertriglyceridemia","drugRate":"5%","severity":"common","organSystem":""},{"effect":"Leg pain","drugRate":"5%","severity":"common","organSystem":""},{"effect":"Injection site reactions/rashes","drugRate":"6.1%","severity":"common","organSystem":""},{"effect":"Lipoatrophy","drugRate":"6.1%","severity":"common","organSystem":""}],"contraindications":["Acute critical illness after open heart surgery, abdominal surgery, multiple accidental trauma, or acute respiratory failure","Pediatric patients with Prader-Willi syndrome who are severely obese, have history of upper airway obstruction or sleep apnea, or have severe respiratory impairment","Active malignancy","Hypersensitivity to NORDITROPIN or any of its excipients","Active proliferative or severe non-proliferative diabetic retinopathy","Pediatric patients with closed epiphyses"],"specialPopulations":{"Geriatric":"8.5 Geriatric Use The safety and effectiveness of NORDITROPIN in patients aged 65 and over has not been evaluated in clinical studies. Elderly patients may be more sensitive to the action of somatropin, and therefore may be more prone to develop adverse reactions. A lower starting dose and smaller dose increments should be considered for older patients [see Dosage and Administration (2.3) ].","Pediatric":"8.4 Pediatric Use Safety and effectiveness of NORDITROPIN in pediatric patients have been established in growth failure due to inadequate secretion of endogenous growth hormone, short stature associated with Noonan syndrome, short stature associated with Turner syndrome, short stature in children born small for gestational age (SGA) with no catch-up growth by age 2 years to 4 years of age, idiopathic short stature (ISS), and growth failure due to Prader-Willi syndrome (PWS). Growth Failure due t","Pregnancy":"8.1 Pregnancy Risk Summary Limited available data with somatropin use in pregnant women are insufficient to determine a drug-associated risk of adverse developmental outcomes. In animal reproduction studies, there was no evidence of fetal or neonatal harm when pregnant rats were administered subcutaneous NORDITROPIN during organogenesis or during lactation at doses approximately 10-times higher than the maximal clinical dose of 0.016 mg/kg, based on body surface area (see Data). The estimated ba","Specific Populations":"8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary Limited available data with somatropin use in pregnant women are insufficient to determine a drug-associated risk of adverse developmental outcomes. In animal reproduction studies, there was no evidence of fetal or neonatal harm when pregnant rats were administered subcutaneous NORDITROPIN during organogenesis or during lactation at doses approximately 10-times higher than the maximal clinical dose of 0.016 mg/kg, based on body surface are"},"seriousAdverseEvents":[{"effect":"Benign intracranial hypertension","drugRate":"","severity":"serious"},{"effect":"Central precocious puberty","drugRate":"","severity":"serious"},{"effect":"Scoliosis aggravation","drugRate":"","severity":"serious"}]},"trials":[],"aliases":[],"company":"Serono","patents":[],"pricing":[],"_sources":{"fdaNDC":{"url":"","method":"api_direct","source":"FDA NDC Directory","rawText":"","confidence":1,"sourceType":"fda_ndc","retrievedAt":"2026-04-19T22:24:56.331692+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book + Purple Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-19T22:25:14.218205+00:00"},"dailyMed":{"url":"","method":"api_direct","source":"DailyMed (NIH/NLM)","rawText":"","confidence":1,"sourceType":"dailymed","retrievedAt":"2026-04-19T22:24:57.059567+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-19T22:25:22.018598+00:00"},"mechanism":{"url":"","method":"ai_extraction","source":"FDA Label + Haiku","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T08:35:35.445135+00:00"},"chemblData":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1201621/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T22:25:03.769014+00:00"},"fdaRecalls":{"url":"","method":"api_direct","source":"FDA Enforcement/Recalls","rawText":"","confidence":1,"sourceType":"fda_enforcement","retrievedAt":"2026-04-19T22:25:02.101907+00:00"},"overdosage":{"url":"","method":"deterministic","source":"FDA Label (overdosage)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T22:22:08.379254+00:00"},"howSupplied":{"url":"","method":"deterministic","source":"FDA Label (how_supplied)","rawText":"16 HOW SUPPLIED/STORAGE AND HANDLING NORDITROPIN (somatropin) injection is a clear and colorless solution available as FlexPro single-patient-use prefilled pens: • NORDITROPIN FlexPro 5 mg/1.5 mL (orange) NDC 0169-7704-21 • NORDITROPIN FlexPro 10 mg/1.5 mL (blue) NDC 0169-7705-21 • NORDITROPIN FlexPro 15 mg/1.5 mL (green) NDC 0169-7708-21 • NORDITROPIN FlexPro 30 mg/3 mL (purple) NDC 0169-7703-21 NORDITROPIN 5 mg/1.5 mL, 10 mg/1.5 mL, and 15 mg/1.5 mL FlexPro pens are compatible with FlexPro Pen","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T22:21:56.756662+00:00"},"trialDetails":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials with endpoints)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T22:25:25.856693+00:00"},"drugDescription":{"url":"","method":"ai_extraction","source":"FDA Label (description)","aiModel":"featherless","rawText":"11 DESCRIPTION Somatropin is a human growth hormone (GH) produced by recombinant DNA technology using Escherichia Coli. The protein is comprised of 191 amino acids and has a molecular weight of about 22,000 daltons. The amino acid sequence is identical to that of human growth hormone of pituitary origin. NORDITROPIN (somatropin) injection is a sterile, clear and colorless solution for subcutaneous use in ready-to-administer prefilled single-patient-use pens with a volume of 1.5 mL or 3 mL with a","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-19T22:22:08.379170+00:00"},"pharmacokinetics":{"url":"","method":"ai_extraction","source":"FDA Label + Haiku","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T08:35:35.445162+00:00"},"publicationCount":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T22:25:02.231821+00:00"},"faersTotalReports":{"url":"","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-19T22:25:01.702270+00:00"},"fdaClinicalStudies":{"url":"","method":"ai_extraction","source":"FDA Label (clinical_studies, 21,401 chars)","aiModel":"featherless","rawText":"14 CLINICAL STUDIES 14.1 Growth Failure due to Inadequate Secretion of Endogenous Growth Hormone The efficacy and safety of NORDITROPIN was assessed in a multicenter, prospective randomized, open label, dose response study with three doses (0.025, 0.05 and 0.1 mg/kg/day). A total of 111 pediatric patients with GH deficiency were randomized to each dose; 37(0.025 mg/kg/day):38(0.05 mg/kg/day):36(0.1 mg/kg/day). Patients met the following entry criteria: chronological age ≥ 3 years with a skeletal","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-19T22:22:52.739997+00:00"},"recentPublications":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T22:25:03.235704+00:00"},"rxnormFormulations":{"url":"https://rxnav.nlm.nih.gov/REST/drugs.json?name=Somatropin","method":"api_direct","source":"RxNorm (NIH)","rawText":"","confidence":1,"sourceType":"rxnorm","retrievedAt":"2026-04-19T22:24:55.937781+00:00"},"participantFlowData":{"url":"","method":"deterministic","source":"ClinicalTrials.gov participantFlowModule","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T22:25:25.856620+00:00"},"safety.safetySignals":{"url":"","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-19T22:24:57.839931+00:00"},"mechanism.oneSentence":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"12.1 Mechanism of Action Somatropin binds to dimeric GH receptors located within the cell membranes of target tissue cells. This interaction results in intracellular signal transduction and subsequent induction of transcription and translation of GH-dependent proteins including IGF-1, IGF BP-3 and acid-labile subunit. Somatropin has direct tissue and metabolic effects or mediated indirectly by IGF-1, including stimulation of chondrocyte differentiation, and proliferation, stimulation hepatic glu","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-19T22:24:55.796064+00:00"},"nonclinicalToxicology":{"url":"","method":"deterministic","source":"FDA Label (nonclinical_toxicology)","rawText":"13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity and mutagenicity studies have not been conducted with NORDITROPIN. In a rat study evaluating female fertility, animals were administered once daily subcutaneous doses of 0.1, 0.3, and 1.1 mg/kg NORDITROPIN beginning two weeks prior to mating, throughout mating and during the first 7 days of pregnancy. Delays in the time to mating were observed at doses greater than or equal to 0.3 mg/kg (approxima","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T22:22:08.379249+00:00"},"structuredTrialResults":{"url":"","method":"deterministic","source":"ClinicalTrials.gov resultsSection (0 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T22:25:25.856617+00:00"},"safety.drugInteractions":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-19T22:24:31.119318+00:00"},"commercial.annualRevenue":{"url":"","method":"deterministic","source":"SEC EDGAR 10-K","rawText":"$446M FY2025","confidence":1,"sourceType":"sec_edgar","retrievedAt":"2026-04-19T22:25:14.218252+00:00"},"safety.commonSideEffects":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials with results)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T22:25:25.856561+00:00"},"safety.contraindications":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-19T22:24:40.236547+00:00"},"safety.specialPopulations":{"url":"","method":"deterministic","source":"FDA Label (special populations)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T22:24:31.119486+00:00"},"safety.seriousAdverseEvents":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T22:25:25.856585+00:00"}},"allNames":"omnitrope","dailyMed":[{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=58d84ffa-4056-4e36-ad67-7bd4aef444a5","setid":"58d84ffa-4056-4e36-ad67-7bd4aef444a5","title":"OMNITROPE (SOMATROPIN) INJECTION, SOLUTION OMNITROPE (SOMATROPIN) KIT [SANDOZ INC]"},{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=85ba081b-bee0-4a9a-aa0f-ae5b5e9a0886","setid":"85ba081b-bee0-4a9a-aa0f-ae5b5e9a0886","title":"ZOMACTON (SOMATROPIN) KIT [FERRING PHARMACEUTICALS INC.]"},{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a774e1ae-3997-49ee-8b0e-99a2b315d409","setid":"a774e1ae-3997-49ee-8b0e-99a2b315d409","title":"HUMATROPE (SOMATROPIN) KIT [ELI LILLY AND COMPANY]"},{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1058e17c-9261-459c-a3e6-fae38d196c14","setid":"1058e17c-9261-459c-a3e6-fae38d196c14","title":"NORDITROPIN (SOMATROPIN) INJECTION, SOLUTION [NOVO NORDISK]"},{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=139d2038-e6a9-4ab1-ab00-aa7d8aa8df5f","setid":"139d2038-e6a9-4ab1-ab00-aa7d8aa8df5f","title":"NUTROPIN AQ NUSPIN 5 (SOMATROPIN) INJECTION, SOLUTION NUTROPIN AQ NUSPIN 10 (SOMATROPIN) INJECTION, SOLUTION NUTROPIN AQ NUSPIN 20 (SOMATROPIN) INJECTION, SOLUTION [GENENTECH, INC.]"}],"offLabel":[],"synonyms":["somatropin","somatropine","human growth hormone","somatotropin (human)","omnitrope","somatropin recombinant","somatropin [rDNA origin]"],"timeline":[{"date":"1976-07-30","type":"positive","source":"DrugCentral","milestone":"FDA approval (Serono)"},{"date":"2006-04-12","type":"positive","source":"DrugCentral","milestone":"EMA approval (Sandoz Gmbh)"}],"aiSummary":"NORDITROPIN (somatropin) is a recombinant human growth hormone indicated for pediatric growth failure from GH deficiency and multiple short stature conditions, as well as adult GH replacement therapy. The drug binds GH receptors to stimulate IGF-1 production and protein synthesis, with subcutaneous administration achieving peak levels in 3-5 hours and a 7-10 hour half-life. Major contraindications include acute critical illness, active malignancy, closed epiphyses in children, and severe diabetic retinopathy; glucocorticoid and CP450 drug interactions require monitoring. NORDITROPIN represents an established therapy for GH deficiency with well-characterized pharmacokinetics and defined safety parameters requiring careful patient selection and monitoring.","brandName":"Omnitrope","ecosystem":[{"indication":"Growth retardation","otherDrugs":[{"name":"somatrem","slug":"somatrem","company":"Genentech"}],"globalPrevalence":null},{"indication":"Pituitary dwarfism","otherDrugs":[{"name":"sermorelin","slug":"sermorelin","company":""},{"name":"somatrem","slug":"somatrem","company":"Genentech"}],"globalPrevalence":null},{"indication":"Prader-Willi syndrome","otherDrugs":[],"globalPrevalence":null},{"indication":"Severe growth hormone deficiency in adulthood","otherDrugs":[],"globalPrevalence":null},{"indication":"Turner syndrome","otherDrugs":[],"globalPrevalence":null}],"mechanism":{"target":"Dimeric GH receptors on cell membranes of target tissues","novelty":"First-in-class","targets":[{"gene":"GHR","source":"DrugCentral","target":"Growth hormone receptor","protein":"Growth hormone receptor"}],"modality":"Protein hormone","drugClass":"Recombinant human growth hormone","explanation":"Somatropin binds to dimeric GH receptors located within cell membranes of target tissue cells, triggering intracellular signal transduction and subsequent induction of transcription and translation of GH-dependent proteins including IGF-1, IGF BP-3, and acid-labile subunit. The drug exerts direct tissue and metabolic effects or acts indirectly through IGF-1, including stimulation of chondrocyte differentiation and proliferation, stimulation of hepatic glucose output, protein synthesis, and lipolysis. In pediatric patients with GHD, somatropin stimulates skeletal growth through effects on the growth plates (epiphyses) of long bones, increasing linear growth rate (height velocity) in most treated patients through increased cellular protein synthesis.","oneSentence":"Somatropin binds dimeric GH receptors on target cells, inducing intracellular signaling and GH-dependent protein synthesis including IGF-1.","technicalDetail":"Somatropin binds to dimeric GH receptors located within the cell membranes of target tissue cells, leading to intracellular signal transduction and the induction of transcription and translation of GH-dependent proteins, including IGF-1, IGF BP-3, and acid-labile subunit."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Growth_hormone_therapy","title":"Growth hormone therapy","extract":"Growth hormone therapy refers to the use of growth hormone (GH) as a prescription medication—it is one form of hormone therapy. Growth hormone is a peptide hormone secreted by the pituitary gland that stimulates growth and cell reproduction. In the past, growth hormone was extracted from human pituitary glands. Growth hormone is now produced by recombinant DNA technology and is prescribed for a variety of reasons. GH therapy has been a focus of social and ethical controversies for 50 years.","wiki_history":"==History==\nPerhaps the most famous person who exemplified the appearance of untreated congenital growth hormone deficiency was Charles Sherwood Stratton (1838–1883), who was exhibited by P. T. Barnum as General Tom Thumb, and married Lavinia Warren. Pictures of the couple show the typical adult features of untreated severe growth hormone deficiency. Despite the severe shortness, limbs and trunks are proportional.\n\nBy the middle of the twentieth century, endocrinologists understood the clinical features of growth hormone deficiency. GH is a protein hormone, like insulin, which had been purified from pig and cow pancreases for treatment of type 1 diabetes since the 1920s. However, pig and cow GH did not work at all in humans, due to greater species-to-species variation of molecular structure (i.e., insulin is considered more \"evolutionarily conserved\" than GH).\n\n===Extraction for treatment===\n\nExtracted growth hormone was used since the late 1950s until the late 1980s when its use was replaced by recombinant GH.\n\nIn the late 1950s, Maurice Raben purified enough GH from human pituitary glands to successfully treat a GH-deficient boy. A few endocrinologists began to help parents of severely GH-deficient children to make arrangements with local pathologists to collect human pituitary glands after removal at autopsy. Parents would then contract with a biochemist to purify enough growth hormone to treat their child. Few families could manage such a complicated undertaking.\n\nIn 1960, the National Pituitary Agency was formed as a branch of the U.S. National Institutes of Health. The purpose of this agency was to supervise the collection of human pituitary glands when autopsies were performed, arrange for large-scale extraction and purification of GH, and distribute it to a limited number of pediatric endocrinologists for treating GH-deficient children under research protocols. Canada, UK, Australia, New Zealand, France, Israel, and other countries establish similar governme"},"chemblData":{"prodrug":0,"chemblId":"CHEMBL1201621","maxPhase":"4.0","chirality":1,"parenteral":true,"availability":1,"moleculeType":"Protein","withdrawnFlag":false,"naturalProduct":0,"blackBoxWarning":0,"oralBioavailable":false},"commercial":{"launchDate":"1976","revenueYear":2025,"_launchSource":"DrugCentral (FDA 1976-07-30, SERONO)","annualRevenue":446,"revenueSource":"Verified: Pfizer 8-K FY2025","revenueCurrency":"USD","revenueConfidence":"verified","revenueExtractedAt":"2026-04-01T11:46:12.481336","revenueExtractedBy":"revenue-sec"},"fdaRecalls":[{"date":"20160427","reason":"Defective Delivery System; may have a low frequency assembly fault which may result in pens block during the so-called \"air shot\" step","status":"Terminated","distribution":"Nationwide","classification":"Class II"}],"overdosage":"10 OVERDOSAGE Short-term overdosage could lead initially to hypoglycemia and subsequently to hyperglycemia. Overdose with somatropin is likely to cause fluid retention. Long-term overdosage could result in signs and symptoms of gigantism and/or acromegaly consistent with the known effects of excess growth hormone .","references":[{"id":1,"url":"https://drugcentral.org/drugcard/4848","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=Somatropin","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Somatropin","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Growth_hormone_therapy","fields":["history","overview"],"source":"Wikipedia"}],"_emaChecked":true,"_enrichedAt":"2026-03-30T01:47:12.442016","_validation":{"fieldsValidated":6,"lastValidatedAt":"2026-04-20T08:35:52.507700+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[{"form":"INJECTION, SOLUTION","route":"SUBCUTANEOUS","company":"Novo Nordisk","brandName":"Norditropin","isOriginal":false,"marketingStatus":"BLA"},{"form":"INJECTION, SOLUTION","route":"SUBCUTANEOUS","company":"Genentech, Inc.","brandName":"Nutropin AQ NuSpin 10","isOriginal":false,"marketingStatus":"BLA"},{"form":"INJECTION, SOLUTION","route":"SUBCUTANEOUS","company":"Genentech, Inc.","brandName":"Nutropin AQ NuSpin 20","isOriginal":false,"marketingStatus":"BLA"},{"form":"INJECTION, SOLUTION","route":"SUBCUTANEOUS","company":"Genentech, Inc.","brandName":"Nutropin AQ NuSpin 5","isOriginal":false,"marketingStatus":"BLA"},{"form":"INJECTION, SOLUTION","route":"SUBCUTANEOUS","company":"Sandoz Inc","brandName":"Omnitrope","isOriginal":false,"marketingStatus":"BLA"}],"competitors":[{"drugName":"somatrem","drugSlug":"somatrem","fdaApproval":"1985-10-17","relationship":"same-class"},{"drugName":"mecasermin","drugSlug":"mecasermin","fdaApproval":"2005-08-30","relationship":"same-class"},{"drugName":"sermorelin","drugSlug":"sermorelin","fdaApproval":"1990-12-28","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"mecasermin rinfabate","drugSlug":"mecasermin-rinfabate","fdaApproval":"2005-12-12","relationship":"same-class"},{"drugName":"tesamorelin","drugSlug":"tesamorelin","fdaApproval":"2010-11-10","relationship":"same-class"},{"drugName":"somapacitan","drugSlug":"somapacitan","fdaApproval":"2020-08-28","relationship":"same-class"},{"drugName":"somatrogon","drugSlug":"somatrogon","fdaApproval":"2023-06-27","relationship":"same-class"},{"drugName":"lonapegsomatropin","drugSlug":"lonapegsomatropin","fdaApproval":"2021-08-25","relationship":"same-class"}],"genericName":"somatropin","howSupplied":"16 HOW SUPPLIED/STORAGE AND HANDLING NORDITROPIN (somatropin) injection is a clear and colorless solution available as FlexPro single-patient-use prefilled pens: • NORDITROPIN FlexPro 5 mg/1.5 mL (orange) NDC 0169-7704-21 • NORDITROPIN FlexPro 10 mg/1.5 mL (blue) NDC 0169-7705-21 • NORDITROPIN FlexPro 15 mg/1.5 mL (green) NDC 0169-7708-21 • NORDITROPIN FlexPro 30 mg/3 mL (purple) NDC 0169-7703-21 NORDITROPIN 5 mg/1.5 mL, 10 mg/1.5 mL, and 15 mg/1.5 mL FlexPro pens are compatible with FlexPro PenMate. The FlexPro PenMate is an accessory device that is dispensed separately with its enclosed Instructions for Use. NORDITROPIN 30 mg/3 mL FlexPro pen is not compatible with FlexPro PenMate. Each NORDITROPIN FlexPro pen is for use by a single patient. A NORDITROPIN FlexPro pen must never be shared between patients, even if the needle is changed. Unused NORDITROPIN FlexPro prefilled pens must be stored refrigerated at 2°C to 8°C (36°F to 46°F). Do not store directly adjacent to the refrigerator cooling element. Do not freeze. Avoid direct light. Table 14 – Storage Conditions and Expiration Before Use In-use (After 1 st injection) Storage requirement Storage Option 1 (Refrigeration) Storage Option 2 (Room temperature) 2ºC to 8ºC (36ºF to 46ºF) Until exp. date 2ºC to 8ºC (36ºF to 46ºF) 4 weeks Up to 25ºC (77ºF) 3 weeks","indications":{"approved":[{"name":"Growth retardation","source":"DrugCentral","snomedId":444896005,"regulator":"FDA"},{"name":"Pituitary dwarfism","source":"DrugCentral","snomedId":367460001,"regulator":"FDA"},{"name":"Prader-Willi syndrome","source":"DrugCentral","snomedId":89392001,"regulator":"FDA"},{"name":"Severe growth hormone deficiency in adulthood","source":"DrugCentral","snomedId":421684006,"regulator":"FDA"},{"name":"Turner syndrome","source":"DrugCentral","snomedId":38804009,"regulator":"FDA"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"somatrem","brandName":"somatrem","genericName":"somatrem","approvalYear":"1985","relationship":"same-class"},{"drugId":"mecasermin","brandName":"mecasermin","genericName":"mecasermin","approvalYear":"2005","relationship":"same-class"},{"drugId":"sermorelin","brandName":"sermorelin","genericName":"sermorelin","approvalYear":"1990","relationship":"same-class"},{"drugId":"mecasermin-rinfabate","brandName":"mecasermin rinfabate","genericName":"mecasermin rinfabate","approvalYear":"2005","relationship":"same-class"},{"drugId":"tesamorelin","brandName":"tesamorelin","genericName":"tesamorelin","approvalYear":"2010","relationship":"same-class"},{"drugId":"somapacitan","brandName":"somapacitan","genericName":"somapacitan","approvalYear":"2020","relationship":"same-class"},{"drugId":"somatrogon","brandName":"somatrogon","genericName":"somatrogon","approvalYear":"2023","relationship":"same-class"},{"drugId":"lonapegsomatropin","brandName":"lonapegsomatropin","genericName":"lonapegsomatropin","approvalYear":"2021","relationship":"same-class"}],"trialDetails":[],"_emaApprovals":[{"date":"2006-04-12","status":"Authorised","company":"SANDOZ GMBH"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Subcutaneous","formulation":"Injection","formulations":[{"form":"INJECTION, SOLUTION","route":"SUBCUTANEOUS","productName":"Norditropin"},{"form":"INJECTION, SOLUTION","route":"SUBCUTANEOUS","productName":"Nutropin AQ NuSpin 10"},{"form":"INJECTION, SOLUTION","route":"SUBCUTANEOUS","productName":"Nutropin AQ NuSpin 20"},{"form":"INJECTION, SOLUTION","route":"SUBCUTANEOUS","productName":"Nutropin AQ NuSpin 5"},{"form":"INJECTION, SOLUTION","route":"SUBCUTANEOUS","productName":"Omnitrope"},{"form":"INJECTION, SOLUTION","route":"SUBCUTANEOUS","productName":"Norditropin"}]},"crossReferences":{"NUI":"N0000148258","MMSL":"5501","NDDF":"002104","UNII":"NQX9KB6PCL","VUID":"4020552","VANDF":"4020552","INN_ID":"239","RXNORM":"61148","UMLSCUI":"C3714500","chemblId":"CHEMBL1201621","ChEMBL_ID":"CHEMBL1201621","KEGG_DRUG":"D02691","DRUGBANK_ID":"DB00052","PUBCHEM_CID":"16132356","SNOMEDCT_US":"129495007","MESH_DESCRIPTOR_UI":"D019382"},"drugDescription":{"pH":"6.13–6.20","structure":"The protein is comprised of 191 amino acids","appearance":"sterile, clear and colorless solution","composition":"Somatropin, Histidine, Mannitol, Phenol, Poloxamer 188, Hydrochloric acid/sodium hydroxide to adjust pH, Water for Injection, USP","molecularWeight":"22,000 daltons","molecularFormula":""},"formularyStatus":[],"_enricherVersion":"v2","chemblMechanisms":[{"actionType":"AGONIST","targetChemblId":"CHEMBL1976","mechanismComment":"It's a recombinant protein approved for the treatment of growth hormone deficiency","mechanismOfAction":"Growth hormone receptor agonist"}],"developmentCodes":[],"ownershipHistory":[{"period":"1976-","companyName":"Serono","relationship":"Original Developer"},{"period":"2006","companyName":"Sandoz Gmbh","relationship":"EMA Licensee"}],"pharmacokinetics":{"tmax":"Subcutaneous: approximately 3.0 hours (4 mg dose in healthy subjects); 4 to 5 hours post-dose (adult GHD patients); IV infusion: 150 minutes","halfLife":"Healthy subjects: 2.0 (0.5) hours; GHD patients IV infusion: 21.1 (5.1) minutes terminal; GHD patients SC: 7 to 10 hours","clearance":"GHD patients IV infusion: 2.3 (1.8) mL/min/kg or 139 (105) mL/min","excretion":"Urinary excretion of intact somatropin has not been 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Open Label, Dose Response","pValue":"","patients":111,"trialName":"Multicenter, prospective randomized, open label, dose response study","conclusion":"Higher doses of NORDITROPIN resulted in greater increases in HSDS, with no significant difference between 0.05 and 0.1 mg/kg/day doses.","indication":"Growth Failure due to Inadequate Secretion of Endogenous Growth Hormone","hazardRatio":"","primaryResult":"Adjusted mean increases in HSDS: 0.81 (0.025 mg/kg/day), 1.57 (0.05 mg/kg/day), 1.73 (0.1 mg/kg/day)","primaryEndpoint":"Change in Height Standard Deviation Score (HSDS) over 2 years","comparatorResult":"No significant difference in ΔHSDS between 0.05 and 0.1 mg/kg/day groups","confidenceInterval":""},{"nctId":"","design":"Randomized, Open Label, Parallel Group","pValue":"","patients":24,"trialName":"Prospective, open label, randomized, parallel group study","conclusion":"NORDITROPIN treatment resulted in significant height gains, with a mean gain of 9.9 cm in boys and 9.1 cm in girls at 18 years of age (national reference), and 11.5 cm in boys and 11.0 cm in girls at 18 years of age (Noonan reference).","indication":"Short Stature Associated with Noonan Syndrome","hazardRatio":"","primaryResult":"FH gain from baseline: 1.5 SDS (national reference), 1.6 SDS (Noonan reference)","primaryEndpoint":"Final Height (FH) gain from baseline","comparatorResult":"Historical reference materials of height velocity and adult height analyses of Noonan patients","confidenceInterval":""},{"nctId":"","design":"Randomized, Open Label, Parallel Group","pValue":"","patients":68,"trialName":"Two randomized, parallel group, open label, multicenter studies","conclusion":"Escalated dose regimens (Dose B and C) resulted in significantly greater mean changes in height SDS compared to the constant dose regimen (Dose A). Mean height gains were 9.4 cm (Dose A), 14.1 cm (Dose B), and 14.4 cm (Dose C) using the Turner standard, and 4.5 cm (Dose A), 9.1 cm (Dose B), and 9.4 cm (Dose C) using the National standard.","indication":"Short Stature Associated with Turner Syndrome","hazardRatio":"","primaryResult":"Overall mean final height: 161 cm; 70% reached normal final height (height SDS > -2 using the National standard)","primaryEndpoint":"Final Height (FH) and change in height SDS","comparatorResult":"Reference data for untreated Turner syndrome patients and the national Dutch population","confidenceInterval":""},{"notes":"Peak height velocity (HV) was observed during treatment Year 1 and then gradually decreased each year. Between Year 2 and Year 6, a greater HV was observed in the two dose escalation groups compared to the 0.045 mg/kg/day group.","studyName":"Study 1: Turner Syndrome","totalPatients":46,"treatmentGroups":[{"n":19,"dose":"0.045 mg/kg/day","finalHeightCm":157,"heightSDSFinal":1.7,"heightSDSChange":1.5,"baselineHeightCm":105,"nationalHeightSDSFinal":-1.9,"normalHeightPercentage":53,"nationalHeightSDSChange":0.7},{"n":15,"dose":"up to 0.067 mg/kg/day","finalHeightCm":163,"heightSDSFinal":2.5,"heightSDSChange":2.2,"baselineHeightCm":108,"nationalHeightSDSFinal":-1.2,"normalHeightPercentage":80,"nationalHeightSDSChange":1.4},{"n":12,"dose":"up to 0.089 mg/kg/day","finalHeightCm":163,"heightSDSFinal":2.5,"heightSDSChange":2.2,"baselineHeightCm":107,"nationalHeightSDSFinal":-1.2,"normalHeightPercentage":83,"nationalHeightSDSChange":1.4}]},{"notes":"No significant differences were observed between the two treatment groups for any linear growth variables, so the data were pooled. Overall mean final height was 155 cm, and height SDS improved significantly from -3.5 at baseline to -2.4 at final height (National standard) and from 0.7 to 1.3 at final height (Turner standard).","studyName":"Study 2: Turner Syndrome","totalPatients":19,"treatmentGroups":[{"n":19,"dose":"0.067 mg/kg/day (single dose in the evening)","finalHeightCm":155,"baselineAgeYears":13.6,"turnerHeightSDSChange":0.6,"nationalHeightSDSChange":1.1,"baselineHeightSDSNational":-3.5,"meanTreatmentDurationYears":3.6,"baselineHeightVelocityCmYear":4.3},{"n":19,"dose":"0.067 mg/kg/day (divided into two doses, 1/3 morning and 2/3 evening)","finalHeightCm":155,"baselineAgeYears":13.6,"turnerHeightSDSChange":0.6,"nationalHeightSDSChange":1.1,"baselineHeightSDSNational":-3.5,"meanTreatmentDurationYears":3.6,"baselineHeightVelocityCmYear":4.3}]},{"notes":"Mean duration of treatment was 9.5 years for boys and 7.9 years for girls. 38 out of 53 children (72%) reached final height, with 63% (24 out of 38) within the normal range of their healthy peers. Both mean final height SDS and increase in height SDS from baseline to final height were significantly greater after treatment with Dose B (0.067 mg/kg/day).","studyName":"Study 1: Short Stature in Pediatric Patients Born SGA","totalPatients":53,"treatmentGroups":[{"n":26,"dose":"0.033 mg/kg/day","heightSDSChangeYear2":1.4,"finalHeightSDSNational":-1.8,"normalHeightPercentage":68,"baselineHeightSDSNational":-3.2,"heightSDSChangeFinalHeight":1.4},{"n":27,"dose":"0.067 mg/kg/day","heightSDSChangeYear2":1.8,"finalHeightSDSNational":-1.3,"normalHeightPercentage":58,"baselineHeightSDSNational":-3.2,"heightSDSChangeFinalHeight":1.8}]}],"recentPublications":[{"pmid":"41955533","title":"Metabolic and muscular effects of switching from somatropin to somapacitan in adults with growth hormone deficiency.","authors":"Oi-Yo Y, Urai S, Yamamoto M, Tomofuji S, Ohmachi Y","journal":"J Clin Endocrinol Metab","pubDate":"2026 Apr 7"},{"pmid":"41516871","title":"Evaluation of Somatropin Release from Chitosan and Methylcellulose Hydrogels: Influence of Hydrogel Composition and Phosvitin on the Release Profile.","authors":"Siemiradzka W, Mizgała W","journal":"Polymers (Basel)","pubDate":"2025 Dec 28"},{"pmid":"41402682","title":"Physicochemical Differences Observed in Photostability Studies of Lyophilized, Reconstituted, and Diluted Somatropin.","authors":"Pritts JD, Ortega-Rodriguez U, Rao VA","journal":"Pharm Res","pubDate":"2026 Jan"},{"pmid":"41268180","title":"Comparing the efficacy and safety of weekly somatrogon with daily somatropin in Asian children living with growth hormone deficiency: a plain language summary of publication.","authors":"Gomez R, Khadilkar V, Shembalkar J, Chu DM, Ko CW","journal":"Ther Adv Endocrinol Metab","pubDate":"2025"},{"pmid":"40438980","title":"Myopathy, lactic acidosis and sideroblastic anemia syndrome 1 (MLASA1): clinical hallmarks in a large pedigree with a novel PUS1 R144Q mutation, remarkable response to somatropin, and review of the literature.","authors":"Parisi L, Escher R","journal":"Haematologica","pubDate":"2025 Nov 1"},{"pmid":"40436776","title":"Improvement in body composition of Japanese participants with Prader-Willi syndrome following somatropin treatment: an open-label, multi cohort Phase 3 study.","authors":"Kawai M, Murakami N, Horikawa R, Muroya K, Fujisawa Y","journal":"Endocr J","pubDate":"2025 Aug 1"},{"pmid":"40042634","title":"Safety and effectiveness of a biosimilar somatropin (Cinnatropin®) in children and adolescents receiving growth hormone therapy over 1 year: a registry-based phase IV study.","authors":"Rabbani A, Razzaghy-Azar M, Karamizadeh Z, Hashemipour M, Vakili R","journal":"Eur J Pediatr","pubDate":"2025 Mar 5"},{"pmid":"39936080","title":"A study looking at how missed somatropin injections affect growth in children with growth hormone deficiency: a plain language summary of publication.","authors":"Loftus J, Miller BS, Parzynski CS, Alvir J, Chen Y","journal":"Ther Adv Endocrinol Metab","pubDate":"2025"},{"pmid":"39883391","title":"Correction to: Long-term safety and effectiveness of a somatropin biosimilar (Omnitrope®) in children requiring growth hormone therapy: analysis of final data of Italian patients enrolled in the PATRO children study.","authors":"Iughetti L, Antoniazzi F, Giavoli C, Bellone S, Aversa T","journal":"Endocrine","pubDate":"2025 May"},{"pmid":"39843388","title":"Clinical outcomes of switching to lonapegsomatropin from somatropin for treatment of pediatric growth hormone deficiency.","authors":"Coyne E, Muthuvel G, Gutmark-Little I","journal":"J Pediatr Endocrinol Metab","pubDate":"2025 Mar 26"}],"rxnormFormulations":[{"tty":"SBD","name":"somatropin 10 MG/ML Injectable Solution [Zomacton]","rxcui":"1648160","synonym":"Zomacton 10 MG/ML Injectable Solution"},{"tty":"SBD","name":"somatropin 5 MG/ML Injectable Solution [Zomacton]","rxcui":"1648162","synonym":"Zomacton 5 MG/ML Injectable Solution"},{"tty":"SBD","name":"2 ML somatropin 10 MG/ML 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In a rat study evaluating female fertility, animals were administered once daily subcutaneous doses of 0.1, 0.3, and 1.1 mg/kg NORDITROPIN beginning two weeks prior to mating, throughout mating and during the first 7 days of pregnancy. Delays in the time to mating were observed at doses greater than or equal to 0.3 mg/kg (approximately 3 times the maximum adult clinical dose of 0.016 mg/kg, based on body surface area), but these doses were also associated with increases in the number of corpora lutea and implantations. A decrease in the pregnancy rate was observed at the dose of 1.1 mg/kg (approximately 10 times the clinical dose of 0.016 mg/kg, based on body surface area). Male fertility parameters have not been evaluated with administration of NORDITROPIN.","structuredTrialResults":[],"genericManufacturerList":[],"faersSeriousnessBreakdown":[{"term":2,"count":50740},{"term":1,"count":18446}],"status":"approved","companyName":"Serono","companyId":"serono","modality":"Recombinant 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