{"id":"dexrazoxane","rwe":[{"pmid":"41893369","year":"2026","title":"Exploring the Pleiotropic Cardioprotective Effects of GLP-1 Receptor Agonists in Preventing Anthracycline-Induced Cardiotoxicity: A Theoretical Proposal for Future Research.","finding":"","journal":"Medicines (Basel, Switzerland)","studyType":"Clinical Study"},{"pmid":"41832729","year":"2026","title":"Chemotherapy-Induced Cardiotoxicity: A Comprehensive Review of Current Understanding and Future Directions.","finding":"","journal":"Current cardiology reviews","studyType":"Clinical Study"},{"pmid":"41821291","year":"2026","title":"Effects of anthracyclines on arteriosclerosis and the protective effect of dexrazoxane in breast cancer patients.","finding":"","journal":"Journal of chemotherapy (Florence, Italy)","studyType":"Clinical Study"},{"pmid":"41809976","year":"2026","title":"Heart transplantation in pediatric oncology patients.","finding":"","journal":"JHLT open","studyType":"Clinical Study"},{"pmid":"41803319","year":"2026","title":"Network pharmacology-based therapeutic intervention of Mentha arvensis targeting cancer and doxorubicin-induced cardiotoxicity.","finding":"","journal":"Investigational new drugs","studyType":"Clinical Study"}],"_fda":{"id":"032583c8-f4e7-4105-b92e-b5c3f96ca80e","set_id":"68089182-d4a2-4053-8d0d-fc97a901515d","openfda":{"unii":["5346058Q7S"],"route":["INTRAVENOUS"],"rxcui":["1736585","1736590"],"spl_id":["032583c8-f4e7-4105-b92e-b5c3f96ca80e"],"brand_name":["Dexrazoxane"],"spl_set_id":["68089182-d4a2-4053-8d0d-fc97a901515d"],"package_ndc":["0143-9247-01","0143-9248-01"],"product_ndc":["0143-9247","0143-9248"],"generic_name":["DEXRAZOXANE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["DEXRAZOXANE HYDROCHLORIDE"],"manufacturer_name":["Hikma Pharmaceuticals USA Inc."],"application_number":["ANDA076068"],"is_original_packager":[true]},"version":"8","pregnancy":["8.1 Pregnancy Teratogenic Effects. Pregnancy Category D Risk Summary Dexrazoxane for injection can cause fetal harm when administered to pregnant women. Dexrazoxane administration resulted in maternal toxicity, embryotoxicity and teratogenicity in rats and rabbits at doses significantly lower than the clinically recommended dose. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see Warnings and Precautions (5.5)] . Animal Data Dexrazoxane resulted in maternal toxicity in rats at doses of ≥2 mg/kg (1/40 the human dose on a mg/m 2 basis) and embryotoxicity and teratogenicity at 8 mg/kg (approximately 1/10 the human dose on a mg/m 2 basis) when given daily to pregnant rats during the period of organogenesis. Teratogenic effects in the rat included imperforate anus, microphthalmia, and anophthalmia. In offspring allowed to develop to maturity, fertility was impaired in the male and female rats treated in utero during organogenesis at 8 mg/kg. In rabbits, doses of ≥5 mg/kg (approximately 1/10 the human dose on a mg/m 2 basis) daily during the period of organogenesis caused maternal toxicity and doses of 20 mg/kg (1/2 the human dose on a mg/m 2 basis) were embryotoxic and teratogenic. Teratogenic effects in the rabbit included several skeletal malformations such as short tail, rib and thoracic malformations, and soft tissue variations including subcutaneous, eye and cardiac hemorrhagic areas, as well as agenesis of the gallbladder and of the intermediate lobe of the lung."],"overdosage":["10 OVERDOSAGE There are no data on overdosage in the cardioprotective trials; the maximum dose administered during the cardioprotective trials was 1000 mg/m 2 every three weeks. Disposition studies with dexrazoxane for injection have not been conducted in cancer patients undergoing dialysis, but retention of a significant dose fraction (>0.4) of the unchanged drug in the plasma pool, minimal tissue partitioning or binding, and availability of greater than 90% of the systemic drug levels in the unbound form suggest that it could be removed using conventional peritoneal or hemodialysis. There is no known antidote for dexrazoxane. Instances of suspected overdose should be managed with good supportive care until resolution of myelosuppression and related conditions is complete. Management of overdose should include treatment of infections, fluid regulation, and maintenance of nutritional requirements."],"references":["15 REFERENCES 1. “OSHA Hazardous Drugs.” OSHA http://www.osha.gov/SLTC/hazardousdrugs/index.html."],"description":["11 DESCRIPTION Dexrazoxane for Injection, a cardioprotective agent for use in conjunction with doxorubicin, is a sterile, pyrogen-free lyophilizate intended for intravenous administration. Chemically, dexrazoxane is (+)-( S )-4,4’-Propylenedi-2,6-piperazinedione. The structural formula is as follows: Structural Formula C 11 H 16 N 4 O 4 M.W. 268.27 Dexrazoxane, an intracellular chelating agent, is a derivative of EDTA. Dexrazoxane is a whitish crystalline powder that melts at 191° to 197°C. It is sparingly soluble in water and 0.1 N HCl, slightly soluble in ethanol and methanol, and practically insoluble in nonpolar organic solvents. The pK a is 2.1. Dexrazoxane has an octanol/water partition coefficient of 0.025 and degrades rapidly above a pH of 7.0. Each 250 mg vial contains dexrazoxane hydrochloride equivalent to 250 mg dexrazoxane. Hydrochloric Acid, NF is added for pH adjustment. When reconstituted as directed with 25 mL of Sterile Water for Injection, USP, each mL contains: 10 mg dexrazoxane. The pH of the resultant solution is 1.0 to 3.0. Each 500 mg vial contains dexrazoxane hydrochloride equivalent to 500 mg dexrazoxane. Hydrochloric Acid, NF is added for pH adjustment. When reconstituted as directed with 50 mL of Sterile Water for Injection, USP, each mL contains: 10 mg dexrazoxane. The pH of the resultant solution is 1.0 to 3.0. The reconstituted dexrazoxane for injection solutions prepared from Sterile Water for Injection, USP, are intended for further dilution with Lactated Ringer’s Injection, USP, for rapid intravenous drip infusion. DO NOT ADMINISTER VIA AN INTRAVENOUS PUSH [see Dosage and Administration (2.1 , 2.3)] . Structural Formula"],"how_supplied":["16 HOW SUPPLIED Dexrazoxane for Injection is available in the following strengths as sterile, pyrogen-free lyophilizates. NDC 0143-9247-01 250 mg single dose vial with a gray flip-top seal, packaged in single vial packs. NDC 0143-9248-01 500 mg single dose vial with a blue flip-top seal, packaged in single vial packs. Store at 20° to 25°C (68° to 77° F) [See USP Controlled Room Temperature]. Follow special handling and disposal procedures. 1"],"geriatric_use":["8.5 Geriatric Use Clinical studies of dexrazoxane for injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy."],"pediatric_use":["8.4 Pediatric Use The safety and effectiveness of dexrazoxane in pediatric patients have not been established [see Warnings and Precautions (5.4)] ."],"effective_time":"20250122","nursing_mothers":["8.3 Nursing Mothers It is not known whether dexrazoxane or its metabolites are excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from dexrazoxane, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother."],"clinical_studies":["14 CLINICAL STUDIES The ability of dexrazoxane for injection to prevent/reduce the incidence and severity of doxorubicin-induced cardiomyopathy was evaluated in three prospectively randomized placebo-controlled studies. In these studies, patients were treated with a doxorubicin-containing regimen and either dexrazoxane for injection or placebo starting with the first course of chemotherapy. There was no restriction on the cumulative dose of doxorubicin. Cardiac function was assessed by measurement of the LVEF, utilizing resting multigated nuclear medicine (MUGA) scans, and by clinical evaluations. Patients receiving dexrazoxane for injection had significantly smaller mean decreases from baseline in LVEF and lower incidences of congestive heart failure than the control group; however, in the largest study, patients with advanced breast cancer receiving FAC with dexrazoxane for injection had a lower response rate (48% vs. 63%) and a shorter time to progression than patients who received FAC versus placebo. In the clinical trials, patients who were initially randomized to receive placebo were allowed to receive dexrazoxane for injection after a cumulative dose of doxorubicin above 300 mg/m 2 . Retrospective historical analyses showed that the risk of experiencing a cardiac event (see Table 3 for definition) at a cumulative dose of doxorubicin above 300 mg/m 2 was greater in the patients who did not receive dexrazoxane for injection beginning with their seventh course of FAC than in the patients who did receive dexrazoxane for injection (HR=13.08; 95% CI: 3.72, 46.03; p<0.001). Overall, 3% of patients treated with dexrazoxane for injection developed CHF compared with 22% of patients not receiving dexrazoxane for injection. Table 3: Definition of Cardiac Events: Development of congestive heart failure, defined as having two or more of the following: Cardiomegaly by X-ray Basilar Rales S3 Gallop Paroxysmal nocturnal dyspnea and/or orthopnea and/or significant dyspnea on exertion. Decline from baseline in LVEF by ≥10% and to below the lower limit of normal for the institution. Decline in LVEF by ≥20% from baseline value. Decline in LVEF to ≥5% below lower limit of normal for the institution. Figure 1 shows the number of patients still on treatment at increasing cumulative doses. Figure 1 Cumulative Number of Patients On Treatment FAC vs. FAC/Dexrazoxane for Injection Patients Patients Receiving at Least Seven Courses of Treatment Figure 1 Figure 1"],"pharmacokinetics":["12.3 Pharmacokinetics The pharmacokinetics of dexrazoxane have been studied in advanced cancer patients with normal renal and hepatic function. The pharmacokinetics of dexrazoxane can be adequately described by a two-compartment open model with first-order elimination. Dexrazoxane has been administered as a 15 minute infusion over a dose range of 60 to 900 mg/m 2 with 60 mg/m 2 of doxorubicin, and at a fixed dose of 500 mg/m 2 with 50 mg/m 2 doxorubicin. The disposition kinetics of dexrazoxane are dose-independent, as shown by linear relationship between the area under plasma concentration-time curves and administered doses ranging from 60 to 900 mg/m 2 . The mean peak plasma concentration of dexrazoxane was 36.5 mcg/mL at 15- minute after intravenous administration of 500 mg/m 2 dose of dexrazoxane for injection over 15 to 30 minutes prior to the 50 mg/m 2 doxorubicin dose. The important pharmacokinetic parameters of dexrazoxane are summarized in Table 2: Table 2: SUMMARY OF MEAN (%CV a ) DEXRAZOXANE PHARMACOKINETIC PARAMETERS AT A DOSAGE RATIO OF 10:1 OF DEXRAZOXANE FOR INJECTION:DOXORUBICIN Dose Dose Number of Elimination Plasma Renal bVolume of Doxorubicin (mg/m2) Dexrazoxane (mg/m2) Subjects Half-Life (h) Clearance (L/h/m2) Clearance (L/h/m2) Distribution (L/m2) 50 500 10 2.5 (16) 7.88 (18) 3.35 (36) 22.4 (22) 60 600 5 2.1 (29) 6.25 (31) — 22.0 (55) a Coefficient of variation b Steady-state volume of distribution Distribution Following a rapid distributive phase (0.2 to 0.3 hours), dexrazoxane reaches post-distributive equilibrium within two to four hours. The estimated mean steady-state volume of distribution of dexrazoxane is 22.4 L/m 2 after 500 mg/m 2 of dexrazoxane for injection dose followed by 50 mg/m 2 of doxorubicin, suggesting distribution throughout total body water (25 L/m 2 ). In vitro studies have shown that dexrazoxane is not bound to plasma proteins. Metabolism Qualitative metabolism studies with dexrazoxane have confirmed the presence of unchanged drug, a diacid-diamide cleavage product, and two monoacid-monoamide ring products in the urine of animals and man. The metabolite levels were not measured in the pharmacokinetic studies. Excretion Urinary excretion plays an important role in the elimination of dexrazoxane. Forty-two percent of a 500 mg/m 2 dose of dexrazoxane for injection was excreted in the urine. Renal clearance averages 3.35 L/h/m 2 after the 500 mg/m 2 dexrazoxane for injection dose followed by 50 mg/m 2 of doxorubicin. Specific Populations Pediatric Pharmacokinetics following dexrazoxane for injection administration have not been evaluated in pediatric patients. Effect of Renal Impairment The pharmacokinetics of dexrazoxane were assessed following a single 15-minute IV infusion of 150 mg/m 2 of dexrazoxane for injection. Dexrazoxane clearance was reduced in subjects with renal dysfunction. Compared with controls, the mean AUC 0-inf value was two-fold greater in subjects with moderate (CL CR 30-50 mL/min) to severe (CL CR <30 mL/min) renal dysfunction. Modeling demonstrated that equivalent exposure (AUC -inf ) could be achieved if dosing were reduced by 50% in subjects with creatinine clearance values <40 mL/min compared with control subjects (CL CR >80 mL/min) [see Use in Specific Populations (8.7) and Dosage and Administration (2.2 )] . Effect of Hepatic Impairment Pharmacokinetics following dexrazoxane for injection administration have not been evaluated in patients with hepatic impairment. The dexrazoxane for injection dose is dependent upon the dose of doxorubicin [see Dosage and Administration (2.2)] . Drug Interactions There was no significant change in the pharmacokinetics of doxorubicin (50 mg/m 2 ) and its predominant metabolite, doxorubicinol, in the presence of dexrazoxane (500 mg/m 2 ) in a crossover study in cancer patients."],"adverse_reactions":["6 ADVERSE REACTIONS In clinical studies, dexrazoxane for injection was administered to patients also receiving chemotherapeutic agents for cancer. Pain on injection was observed more frequently in patients receiving dexrazoxane for injection versus placebo. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other trials and may not reflect the rates observed in clinical practice. The adverse reaction profile described in this section was identified from randomized, placebo- controlled, double-blind studies in patients with metastatic breast cancer who received the combination of the FAC chemotherapy regimen with or without dexrazoxane for injection. The dose of doxorubicin was 50 mg/m 2 in each of these trials. Treatment was administered every three weeks until disease progression or cardiac toxicity. Patients in clinical trials who received FAC with dexrazoxane for injection experienced more severe leukopenia, granulocytopenia, and thrombocytopenia than patients receiving FAC without dexrazoxane for injection [see Warnings and Precautions (5.1 )] . Table 1 below lists the incidence of adverse reactions for patients receiving FAC with either dexrazoxane for injection or placebo in the breast cancer studies. Adverse experiences occurring during courses 1 through 6 are displayed for patients receiving dexrazoxane for injection or placebo with FAC beginning with their first course of therapy (columns 1 and 3, respectively). Adverse experiences occurring at course 7 and beyond for patients who received placebo with FAC during the first six courses and who then received either dexrazoxane for injection or placebo with FAC are also displayed (columns 2 and 4, respectively). The adverse reactions listed below in Table 1 demonstrate that the frequency of adverse reaction “Pain on Injection” has been greater for dexrazoxane for injection arm, as compared to placebo. Table 1 Adverse Reaction Percentage (%) of Breast Cancer Patients With Adverse Reaction FAC + Dexrazoxane FAC + Placebo Courses 1 to 6 N = 413 Courses ≥ 7 N = 102 Courses 1 to 6 N = 458 Courses ≥ 7 N = 99 Alopecia 94 100 97 98 Nausea 77 51 84 60 Vomiting 59 42 72 49 Fatigue/Malaise 61 48 58 55 Anorexia 42 27 47 38 Stomatitis 34 26 41 28 Fever 34 22 29 18 Infection 23 19 18 21 Diarrhea 21 14 24 7 Pain on Injection 12 13 3 0 Sepsis 17 12 14 9 Neurotoxicity 17 10 13 5 Streaking/Erythema 5 4 4 2 Phlebitis 6 3 3 5 Esophagitis 6 3 7 4 Dysphagia 8 0 10 5 Hemorrhage 2 3 2 1 Extravasation 1 3 1 2 Urticaria 2 2 2 0 Recall Skin Reaction 1 1 2 0","6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other trials and may not reflect the rates observed in clinical practice. The adverse reaction profile described in this section was identified from randomized, placebo- controlled, double-blind studies in patients with metastatic breast cancer who received the combination of the FAC chemotherapy regimen with or without dexrazoxane for injection. The dose of doxorubicin was 50 mg/m 2 in each of these trials. Treatment was administered every three weeks until disease progression or cardiac toxicity. Patients in clinical trials who received FAC with dexrazoxane for injection experienced more severe leukopenia, granulocytopenia, and thrombocytopenia than patients receiving FAC without dexrazoxane for injection [see Warnings and Precautions (5.1 )] . Table 1 below lists the incidence of adverse reactions for patients receiving FAC with either dexrazoxane for injection or placebo in the breast cancer studies. Adverse experiences occurring during courses 1 through 6 are displayed for patients receiving dexrazoxane for injection or placebo with FAC beginning with their first course of therapy (columns 1 and 3, respectively). Adverse experiences occurring at course 7 and beyond for patients who received placebo with FAC during the first six courses and who then received either dexrazoxane for injection or placebo with FAC are also displayed (columns 2 and 4, respectively). The adverse reactions listed below in Table 1 demonstrate that the frequency of adverse reaction “Pain on Injection” has been greater for dexrazoxane for injection arm, as compared to placebo. Table 1 Adverse Reaction Percentage (%) of Breast Cancer Patients With Adverse Reaction FAC + Dexrazoxane FAC + Placebo Courses 1 to 6 N = 413 Courses ≥ 7 N = 102 Courses 1 to 6 N = 458 Courses ≥ 7 N = 99 Alopecia 94 100 97 98 Nausea 77 51 84 60 Vomiting 59 42 72 49 Fatigue/Malaise 61 48 58 55 Anorexia 42 27 47 38 Stomatitis 34 26 41 28 Fever 34 22 29 18 Infection 23 19 18 21 Diarrhea 21 14 24 7 Pain on Injection 12 13 3 0 Sepsis 17 12 14 9 Neurotoxicity 17 10 13 5 Streaking/Erythema 5 4 4 2 Phlebitis 6 3 3 5 Esophagitis 6 3 7 4 Dysphagia 8 0 10 5 Hemorrhage 2 3 2 1 Extravasation 1 3 1 2 Urticaria 2 2 2 0 Recall Skin Reaction 1 1 2 0"],"contraindications":["4 CONTRAINDICATIONS Do not use dexrazoxane for injection with non-anthracycline chemotherapy regimens. Dexrazoxane for injection should not be used with non-anthracycline chemotherapy regimens. (4)"],"drug_interactions":["7 DRUG INTERACTIONS No drug interactions have been identified [see Clinical Pharmacology (12.3) ] ."],"mechanism_of_action":["12.1 Mechanism of Action The mechanism by which dexrazoxane for injection exerts its cytoprotective activity is not fully understood. Dexrazoxane is a cyclic derivative of EDTA that penetrates cell membranes. Results of laboratory studies suggest that dexrazoxane is converted intracellularly to a ring-opened chelating agent that interferes with iron-mediated free radical generation thought to be responsible, in part, for anthracycline-induced cardiomyopathy."],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action The mechanism by which dexrazoxane for injection exerts its cytoprotective activity is not fully understood. Dexrazoxane is a cyclic derivative of EDTA that penetrates cell membranes. Results of laboratory studies suggest that dexrazoxane is converted intracellularly to a ring-opened chelating agent that interferes with iron-mediated free radical generation thought to be responsible, in part, for anthracycline-induced cardiomyopathy. 12.3 Pharmacokinetics The pharmacokinetics of dexrazoxane have been studied in advanced cancer patients with normal renal and hepatic function. The pharmacokinetics of dexrazoxane can be adequately described by a two-compartment open model with first-order elimination. Dexrazoxane has been administered as a 15 minute infusion over a dose range of 60 to 900 mg/m 2 with 60 mg/m 2 of doxorubicin, and at a fixed dose of 500 mg/m 2 with 50 mg/m 2 doxorubicin. The disposition kinetics of dexrazoxane are dose-independent, as shown by linear relationship between the area under plasma concentration-time curves and administered doses ranging from 60 to 900 mg/m 2 . The mean peak plasma concentration of dexrazoxane was 36.5 mcg/mL at 15- minute after intravenous administration of 500 mg/m 2 dose of dexrazoxane for injection over 15 to 30 minutes prior to the 50 mg/m 2 doxorubicin dose. The important pharmacokinetic parameters of dexrazoxane are summarized in Table 2: Table 2: SUMMARY OF MEAN (%CV a ) DEXRAZOXANE PHARMACOKINETIC PARAMETERS AT A DOSAGE RATIO OF 10:1 OF DEXRAZOXANE FOR INJECTION:DOXORUBICIN Dose Dose Number of Elimination Plasma Renal bVolume of Doxorubicin (mg/m2) Dexrazoxane (mg/m2) Subjects Half-Life (h) Clearance (L/h/m2) Clearance (L/h/m2) Distribution (L/m2) 50 500 10 2.5 (16) 7.88 (18) 3.35 (36) 22.4 (22) 60 600 5 2.1 (29) 6.25 (31) — 22.0 (55) a Coefficient of variation b Steady-state volume of distribution Distribution Following a rapid distributive phase (0.2 to 0.3 hours), dexrazoxane reaches post-distributive equilibrium within two to four hours. The estimated mean steady-state volume of distribution of dexrazoxane is 22.4 L/m 2 after 500 mg/m 2 of dexrazoxane for injection dose followed by 50 mg/m 2 of doxorubicin, suggesting distribution throughout total body water (25 L/m 2 ). In vitro studies have shown that dexrazoxane is not bound to plasma proteins. Metabolism Qualitative metabolism studies with dexrazoxane have confirmed the presence of unchanged drug, a diacid-diamide cleavage product, and two monoacid-monoamide ring products in the urine of animals and man. The metabolite levels were not measured in the pharmacokinetic studies. Excretion Urinary excretion plays an important role in the elimination of dexrazoxane. Forty-two percent of a 500 mg/m 2 dose of dexrazoxane for injection was excreted in the urine. Renal clearance averages 3.35 L/h/m 2 after the 500 mg/m 2 dexrazoxane for injection dose followed by 50 mg/m 2 of doxorubicin. Specific Populations Pediatric Pharmacokinetics following dexrazoxane for injection administration have not been evaluated in pediatric patients. Effect of Renal Impairment The pharmacokinetics of dexrazoxane were assessed following a single 15-minute IV infusion of 150 mg/m 2 of dexrazoxane for injection. Dexrazoxane clearance was reduced in subjects with renal dysfunction. Compared with controls, the mean AUC 0-inf value was two-fold greater in subjects with moderate (CL CR 30-50 mL/min) to severe (CL CR <30 mL/min) renal dysfunction. Modeling demonstrated that equivalent exposure (AUC -inf ) could be achieved if dosing were reduced by 50% in subjects with creatinine clearance values <40 mL/min compared with control subjects (CL CR >80 mL/min) [see Use in Specific Populations (8.7) and Dosage and Administration (2.2 )] . Effect of Hepatic Impairment Pharmacokinetics following dexrazoxane for injection administration have not been evaluated in patients with hepatic impairment. The dexrazoxane for injection dose is dependent upon the dose of doxorubicin [see Dosage and Administration (2.2)] . Drug Interactions There was no significant change in the pharmacokinetics of doxorubicin (50 mg/m 2 ) and its predominant metabolite, doxorubicinol, in the presence of dexrazoxane (500 mg/m 2 ) in a crossover study in cancer patients."],"indications_and_usage":["1 INDICATIONS AND USAGE Dexrazoxane for injection is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m 2 and who will continue to receive doxorubicin therapy to maintain tumor control. Do not use with the initiation of doxorubicin therapy [see Warnings and Precautions (5.2 )] . Dexrazoxane for injection is a cytoprotective agent indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m 2 and who will continue to receive doxorubicin therapy to maintain tumor control. Do not use dexrazoxane for injection with doxorubicin initiation. (1)"],"warnings_and_cautions":["5 WARNINGS AND PRECAUTIONS Myelosuppression: Dexrazoxane for injection may increase the myelosuppresive effects of chemotherapeutic agents. Perform hematological monitoring. (5.1) Embryo-Fetal Toxicity: Can cause fetal harm. Advise female patients of reproductive potential of the potential hazard to the fetus. ( 5.5 , 8.1 ) 5.1 Myelosuppression Dexrazoxane for injection may add to the myelosuppression caused by chemotherapeutic agents. Obtain a complete blood count prior to and during each course of therapy, and administer dexrazoxane for injection and chemotherapy only when adequate hematologic parameters are met. 5.2 Concomitant Chemotherapy Only use dexrazoxane for injection in those patients who have received a cumulative doxorubicin dose of 300 mg/m 2 and are continuing with doxorubicin therapy. Do not use with chemotherapy initiation as dexrazoxane for injection may interfere with the antitumor activity of the chemotherapy regimen. In a trial conducted in patients with metastatic breast cancer who were treated with fluorouracil, doxorubicin, and cyclophosphamide (FAC) with or without dexrazoxane for injection starting with their first cycle of FAC therapy, patients who were randomized to receive dexrazoxane for injection had a lower response rate (48% vs. 63%) and shorter time to progression than patients who were randomized to receive placebo. 5.3 Cardiac Toxicity Treatment with dexrazoxane for injection does not completely eliminate the risk of anthracycline-induced cardiac toxicity. Monitor cardiac function before and periodically during therapy to assess left ventricular ejection fraction (LVEF). In general, if test results indicate deterioration in cardiac function associated with doxorubicin, the benefit of continued therapy should be carefully evaluated against the risk of producing irreversible cardiac damage. 5.4 Secondary Malignancies Secondary malignancies such as acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) have been reported in studies of pediatric patients who have received dexrazoxane for injection in combination with chemotherapy. Dexrazoxane for injection is not indicated for use in pediatric patients. Some adult patients who received dexrazoxane for injection in combination with anti-cancer agents known to be carcinogenic have also developed secondary malignancies, including AML and MDS. Razoxane is the racemic mixture, of which dexrazoxane is the S(+)-enantiomer. Secondary malignancies (primarily acute myeloid leukemia) have been reported in patients treated chronically with oral razoxane. In these patients, the total cumulative dose of razoxane ranged from 26 to 480 grams and the duration of treatment was from 42 to 319 weeks. One case of T- cell lymphoma, one case of B-cell lymphoma, and six to eight cases of cutaneous basal cell or squamous cell carcinoma have also been reported in patients treated with razoxane. Long-term administration of razoxane to rodents was associated with the development of malignancies [see Nonclinical Toxicology (13.1 )] . 5.5 Embryo-Fetal Toxicity Dexrazoxane for injection can cause fetal harm when administered to pregnant women. Dexrazoxane administration during the period of organogenesis resulted in maternal toxicity, embryotoxicity and teratogenicity in rats and rabbits at doses significantly lower than the clinically recommended dose [see Use in Specific Populations (8.1)] . If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Advise female patients of reproductive potential to avoid becoming pregnant and to use highly effective contraception during treatment [see Use in Specific Populations (8.6 )] .","5.1 Myelosuppression Dexrazoxane for injection may add to the myelosuppression caused by chemotherapeutic agents. Obtain a complete blood count prior to and during each course of therapy, and administer dexrazoxane for injection and chemotherapy only when adequate hematologic parameters are met.","5.2 Concomitant Chemotherapy Only use dexrazoxane for injection in those patients who have received a cumulative doxorubicin dose of 300 mg/m 2 and are continuing with doxorubicin therapy. Do not use with chemotherapy initiation as dexrazoxane for injection may interfere with the antitumor activity of the chemotherapy regimen. In a trial conducted in patients with metastatic breast cancer who were treated with fluorouracil, doxorubicin, and cyclophosphamide (FAC) with or without dexrazoxane for injection starting with their first cycle of FAC therapy, patients who were randomized to receive dexrazoxane for injection had a lower response rate (48% vs. 63%) and shorter time to progression than patients who were randomized to receive placebo.","5.4 Secondary Malignancies Secondary malignancies such as acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) have been reported in studies of pediatric patients who have received dexrazoxane for injection in combination with chemotherapy. Dexrazoxane for injection is not indicated for use in pediatric patients. Some adult patients who received dexrazoxane for injection in combination with anti-cancer agents known to be carcinogenic have also developed secondary malignancies, including AML and MDS. Razoxane is the racemic mixture, of which dexrazoxane is the S(+)-enantiomer. Secondary malignancies (primarily acute myeloid leukemia) have been reported in patients treated chronically with oral razoxane. In these patients, the total cumulative dose of razoxane ranged from 26 to 480 grams and the duration of treatment was from 42 to 319 weeks. One case of T- cell lymphoma, one case of B-cell lymphoma, and six to eight cases of cutaneous basal cell or squamous cell carcinoma have also been reported in patients treated with razoxane. Long-term administration of razoxane to rodents was associated with the development of malignancies [see Nonclinical Toxicology (13.1 )] .","5.5 Embryo-Fetal Toxicity Dexrazoxane for injection can cause fetal harm when administered to pregnant women. Dexrazoxane administration during the period of organogenesis resulted in maternal toxicity, embryotoxicity and teratogenicity in rats and rabbits at doses significantly lower than the clinically recommended dose [see Use in Specific Populations (8.1)] . If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Advise female patients of reproductive potential to avoid becoming pregnant and to use highly effective contraception during treatment [see Use in Specific Populations (8.6 )] ."],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis and Mutagenesis and Impairment of Fertility No long-term carcinogenicity studies have been carried out with dexrazoxane in animals. Nevertheless, a study by the National Cancer Institute has reported that long-term dosing with razoxane (the racemic mixture of dexrazoxane, ICRF-187, and its enantiomer ICRF-186) is associated with the development of malignancies in rats and possibly in mice [see Warnings and Precautions (5.4 )] . Dexrazoxane was not mutagenic in the bacterial reverse mutation (Ames) test, but was found to be clastogenic to human lymphocytes in vitro and to mouse bone marrow erythrocytes in vivo (micronucleus test). Dexrazoxane for injection has the potential to impair fertility in male patients based on effects in repeat-dose toxicology studies. Testicular atrophy was seen with dexrazoxane administration at doses as low as 30 mg/kg weekly for 6 weeks in rats (1/3 the human dose on a mg/m 2 basis) and as low as 20 mg/kg weekly for 13 weeks in dogs (approximately equal to the human dose on a mg/m 2 basis)."],"pharmacokinetics_table":["<table cellspacing=\"0\" cellpadding=\"0\" border=\"0\"><col width=\"68.35pt\"/><col width=\"70.15pt\"/><col width=\"64.65pt\"/><col width=\"73.4pt\"/><col width=\"65.4pt\"/><col width=\"66.35pt\"/><col width=\"70.5pt\"/><tbody><tr><td styleCode=\" Botrule Toprule Lrule Rrule\"><paragraph>Dose</paragraph></td><td styleCode=\" Botrule Toprule Lrule Rrule\"><paragraph>Dose</paragraph></td><td styleCode=\" Botrule Toprule Lrule Rrule\"><paragraph>Number of</paragraph></td><td styleCode=\" Botrule Toprule Lrule Rrule\"><paragraph>Elimination</paragraph></td><td styleCode=\" Botrule Toprule Lrule Rrule\"><paragraph>Plasma</paragraph></td><td styleCode=\" Botrule Toprule Lrule Rrule\"><paragraph>Renal</paragraph></td><td styleCode=\" Botrule Toprule Lrule Rrule\"><paragraph>bVolume of</paragraph></td></tr><tr><td><paragraph>Doxorubicin (mg/m2)</paragraph></td><td><paragraph>Dexrazoxane</paragraph><paragraph>(mg/m2)</paragraph></td><td><paragraph>Subjects</paragraph></td><td><paragraph>Half-Life (h)</paragraph></td><td><paragraph>Clearance (L/h/m2)</paragraph></td><td><paragraph>Clearance (L/h/m2)</paragraph></td><td><paragraph>Distribution (L/m2)</paragraph></td></tr><tr><td styleCode=\" Botrule Toprule Lrule Rrule\"><paragraph>50</paragraph></td><td styleCode=\" Botrule Toprule Lrule Rrule\"><paragraph>500</paragraph></td><td styleCode=\" Botrule Toprule Lrule Rrule\"><paragraph>10</paragraph></td><td styleCode=\" Botrule Toprule Lrule Rrule\"><paragraph>2.5 (16)</paragraph></td><td styleCode=\" Botrule Toprule Lrule Rrule\"><paragraph>7.88 (18)</paragraph></td><td styleCode=\" Botrule Toprule Lrule Rrule\"><paragraph>3.35 (36)</paragraph></td><td styleCode=\" Botrule Toprule Lrule Rrule\"><paragraph>22.4 (22)</paragraph></td></tr><tr><td><paragraph>60</paragraph></td><td><paragraph>600</paragraph></td><td><paragraph>5</paragraph></td><td><paragraph>2.1 (29)</paragraph></td><td><paragraph>6.25 (31)</paragraph></td><td><paragraph>&#x2014;</paragraph></td><td><paragraph>22.0 (55)</paragraph></td></tr></tbody></table>"],"adverse_reactions_table":["<table cellspacing=\"0\" cellpadding=\"0\" border=\"0\"><col width=\"106.8pt\"/><col width=\"372pt\"/><col/><col/><col/><tbody><tr><td rowspan=\"3\" styleCode=\" Botrule Toprule Lrule Rrule\"><paragraph>Adverse Reaction</paragraph></td><td colspan=\"4\"><paragraph>Percentage (%) of Breast Cancer Patients With Adverse Reaction</paragraph></td></tr><tr><td colspan=\"2\"><paragraph>FAC + Dexrazoxane </paragraph></td><td colspan=\"2\"><paragraph>FAC + Placebo</paragraph></td></tr><tr><td><paragraph>Courses 1 to 6</paragraph><paragraph>N = 413</paragraph></td><td><paragraph>Courses &#x2265; 7</paragraph><paragraph>N = 102</paragraph></td><td><paragraph>Courses 1 to 6</paragraph><paragraph>N = 458</paragraph></td><td><paragraph>Courses &#x2265; 7</paragraph><paragraph>N = 99</paragraph></td></tr><tr><td><paragraph>Alopecia</paragraph></td><td><paragraph>94</paragraph></td><td><paragraph>100</paragraph></td><td><paragraph>97</paragraph></td><td><paragraph>98</paragraph></td></tr><tr><td><paragraph>Nausea</paragraph></td><td><paragraph>77</paragraph></td><td><paragraph>51</paragraph></td><td><paragraph>84</paragraph></td><td><paragraph>60</paragraph></td></tr><tr><td><paragraph>Vomiting</paragraph></td><td><paragraph>59</paragraph></td><td><paragraph>42</paragraph></td><td><paragraph>72</paragraph></td><td><paragraph>49</paragraph></td></tr><tr><td><paragraph>Fatigue/Malaise</paragraph></td><td><paragraph>61</paragraph></td><td><paragraph>48</paragraph></td><td><paragraph>58</paragraph></td><td><paragraph>55</paragraph></td></tr><tr><td><paragraph>Anorexia</paragraph></td><td><paragraph>42</paragraph></td><td><paragraph>27</paragraph></td><td><paragraph>47</paragraph></td><td><paragraph>38</paragraph></td></tr><tr><td><paragraph>Stomatitis</paragraph></td><td><paragraph>34</paragraph></td><td><paragraph>26</paragraph></td><td><paragraph>41</paragraph></td><td><paragraph>28</paragraph></td></tr><tr><td><paragraph>Fever</paragraph></td><td><paragraph>34</paragraph></td><td><paragraph>22</paragraph></td><td><paragraph>29</paragraph></td><td><paragraph>18</paragraph></td></tr><tr><td><paragraph>Infection</paragraph></td><td><paragraph>23</paragraph></td><td><paragraph>19</paragraph></td><td><paragraph>18</paragraph></td><td><paragraph>21</paragraph></td></tr><tr><td><paragraph>Diarrhea</paragraph></td><td><paragraph>21</paragraph></td><td><paragraph>14</paragraph></td><td><paragraph>24</paragraph></td><td><paragraph>7</paragraph></td></tr><tr><td><paragraph>Pain on Injection</paragraph></td><td><paragraph>12</paragraph></td><td><paragraph>13</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>0</paragraph></td></tr><tr><td><paragraph>Sepsis</paragraph></td><td><paragraph>17</paragraph></td><td><paragraph>12</paragraph></td><td><paragraph>14</paragraph></td><td><paragraph>9</paragraph></td></tr><tr><td><paragraph>Neurotoxicity</paragraph></td><td><paragraph>17</paragraph></td><td><paragraph>10</paragraph></td><td><paragraph>13</paragraph></td><td><paragraph>5</paragraph></td></tr><tr><td><paragraph>Streaking/Erythema</paragraph></td><td><paragraph>5</paragraph></td><td><paragraph>4</paragraph></td><td><paragraph>4</paragraph></td><td><paragraph>2</paragraph></td></tr><tr><td><paragraph>Phlebitis</paragraph></td><td><paragraph>6</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>5</paragraph></td></tr><tr><td><paragraph>Esophagitis</paragraph></td><td><paragraph>6</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>7</paragraph></td><td><paragraph>4</paragraph></td></tr><tr><td><paragraph>Dysphagia</paragraph></td><td><paragraph>8</paragraph></td><td><paragraph>0</paragraph></td><td><paragraph>10</paragraph></td><td><paragraph>5</paragraph></td></tr><tr><td><paragraph>Hemorrhage</paragraph></td><td><paragraph>2</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>2</paragraph></td><td><paragraph>1</paragraph></td></tr><tr><td><paragraph>Extravasation</paragraph></td><td><paragraph>1</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>1</paragraph></td><td><paragraph>2</paragraph></td></tr><tr><td><paragraph>Urticaria</paragraph></td><td><paragraph>2</paragraph></td><td><paragraph>2</paragraph></td><td><paragraph>2</paragraph></td><td><paragraph>0</paragraph></td></tr><tr><td><paragraph>Recall Skin Reaction</paragraph></td><td><paragraph>1</paragraph></td><td><paragraph>1</paragraph></td><td><paragraph>2</paragraph></td><td><paragraph>0</paragraph></td></tr></tbody></table>","<table cellspacing=\"0\" cellpadding=\"0\" border=\"0\"><col width=\"106.8pt\"/><col width=\"372pt\"/><col/><col/><col/><tbody><tr><td rowspan=\"3\" styleCode=\" Botrule Toprule Lrule Rrule\"><paragraph>Adverse Reaction</paragraph></td><td colspan=\"4\"><paragraph>Percentage (%) of Breast Cancer Patients With Adverse Reaction</paragraph></td></tr><tr><td colspan=\"2\"><paragraph>FAC + Dexrazoxane </paragraph></td><td colspan=\"2\"><paragraph>FAC + Placebo</paragraph></td></tr><tr><td><paragraph>Courses 1 to 6</paragraph><paragraph>N = 413</paragraph></td><td><paragraph>Courses &#x2265; 7</paragraph><paragraph>N = 102</paragraph></td><td><paragraph>Courses 1 to 6</paragraph><paragraph>N = 458</paragraph></td><td><paragraph>Courses &#x2265; 7</paragraph><paragraph>N = 99</paragraph></td></tr><tr><td><paragraph>Alopecia</paragraph></td><td><paragraph>94</paragraph></td><td><paragraph>100</paragraph></td><td><paragraph>97</paragraph></td><td><paragraph>98</paragraph></td></tr><tr><td><paragraph>Nausea</paragraph></td><td><paragraph>77</paragraph></td><td><paragraph>51</paragraph></td><td><paragraph>84</paragraph></td><td><paragraph>60</paragraph></td></tr><tr><td><paragraph>Vomiting</paragraph></td><td><paragraph>59</paragraph></td><td><paragraph>42</paragraph></td><td><paragraph>72</paragraph></td><td><paragraph>49</paragraph></td></tr><tr><td><paragraph>Fatigue/Malaise</paragraph></td><td><paragraph>61</paragraph></td><td><paragraph>48</paragraph></td><td><paragraph>58</paragraph></td><td><paragraph>55</paragraph></td></tr><tr><td><paragraph>Anorexia</paragraph></td><td><paragraph>42</paragraph></td><td><paragraph>27</paragraph></td><td><paragraph>47</paragraph></td><td><paragraph>38</paragraph></td></tr><tr><td><paragraph>Stomatitis</paragraph></td><td><paragraph>34</paragraph></td><td><paragraph>26</paragraph></td><td><paragraph>41</paragraph></td><td><paragraph>28</paragraph></td></tr><tr><td><paragraph>Fever</paragraph></td><td><paragraph>34</paragraph></td><td><paragraph>22</paragraph></td><td><paragraph>29</paragraph></td><td><paragraph>18</paragraph></td></tr><tr><td><paragraph>Infection</paragraph></td><td><paragraph>23</paragraph></td><td><paragraph>19</paragraph></td><td><paragraph>18</paragraph></td><td><paragraph>21</paragraph></td></tr><tr><td><paragraph>Diarrhea</paragraph></td><td><paragraph>21</paragraph></td><td><paragraph>14</paragraph></td><td><paragraph>24</paragraph></td><td><paragraph>7</paragraph></td></tr><tr><td><paragraph>Pain on Injection</paragraph></td><td><paragraph>12</paragraph></td><td><paragraph>13</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>0</paragraph></td></tr><tr><td><paragraph>Sepsis</paragraph></td><td><paragraph>17</paragraph></td><td><paragraph>12</paragraph></td><td><paragraph>14</paragraph></td><td><paragraph>9</paragraph></td></tr><tr><td><paragraph>Neurotoxicity</paragraph></td><td><paragraph>17</paragraph></td><td><paragraph>10</paragraph></td><td><paragraph>13</paragraph></td><td><paragraph>5</paragraph></td></tr><tr><td><paragraph>Streaking/Erythema</paragraph></td><td><paragraph>5</paragraph></td><td><paragraph>4</paragraph></td><td><paragraph>4</paragraph></td><td><paragraph>2</paragraph></td></tr><tr><td><paragraph>Phlebitis</paragraph></td><td><paragraph>6</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>5</paragraph></td></tr><tr><td><paragraph>Esophagitis</paragraph></td><td><paragraph>6</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>7</paragraph></td><td><paragraph>4</paragraph></td></tr><tr><td><paragraph>Dysphagia</paragraph></td><td><paragraph>8</paragraph></td><td><paragraph>0</paragraph></td><td><paragraph>10</paragraph></td><td><paragraph>5</paragraph></td></tr><tr><td><paragraph>Hemorrhage</paragraph></td><td><paragraph>2</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>2</paragraph></td><td><paragraph>1</paragraph></td></tr><tr><td><paragraph>Extravasation</paragraph></td><td><paragraph>1</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>1</paragraph></td><td><paragraph>2</paragraph></td></tr><tr><td><paragraph>Urticaria</paragraph></td><td><paragraph>2</paragraph></td><td><paragraph>2</paragraph></td><td><paragraph>2</paragraph></td><td><paragraph>0</paragraph></td></tr><tr><td><paragraph>Recall Skin Reaction</paragraph></td><td><paragraph>1</paragraph></td><td><paragraph>1</paragraph></td><td><paragraph>2</paragraph></td><td><paragraph>0</paragraph></td></tr></tbody></table>"],"information_for_patients":["17 PATIENT COUNSELING INFORMATION 17.1 Myelosuppression Treatment with dexrazoxane for injection is associated with leukopenia, neutropenia, and thrombocytopenia. Perform hematological monitoring [see Warnings and Precautions ( 5.1 )] . 17.2 Embryo-Fetal Toxicity Counsel patients on pregnancy planning and prevention. Advise female patients of reproductive potential that dexrazoxane for injection can cause fetal harm and to use highly effective contraception during treatment [see Warnings and Precautions ( 5.5 ) and Use in Specific Populations ( 8.1 , 8.6)] . Manufactured By: THYMOORGAN PHARMAZIE GmbH, Schiffgraben 23, 38690 Goslar, Germany Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Revised March 2020 127.207.025/01"],"dosage_and_administration":["2 DOSAGE AND ADMINISTRATION Reconstitute vial contents and dilute before use. (2.3) Administer Dexrazoxane for injection by intravenous infusion over 15 minutes. DO NOT ADMINISTER VIA AN INTRAVENOUS PUSH. ( 2.1 , 2.3 ) The recommended dosage ratio of dexrazoxane for injection to doxorubicin is 10:1 (e.g., 500 mg/m 2 dexrazoxane for injection to 50 mg/m 2 doxorubicin). Do not administer doxorubicin before dexrazoxane for injection. ( 2.1 ) Reduce dose by 50% for patients with creatinine clearance <40 mL/min. ( 2.2 , 8.7 ) 2.1 Recommended Dose Administer dexrazoxane for injection via intravenous infusion over 15 minutes. DO NOT ADMINISTER VIA AN INTRAVENOUS PUSH. The recommended dosage ratio of dexrazoxane for injection to doxorubicin is 10:1 (e.g., 500 mg/m 2 dexrazoxane for injection to 50 mg/m 2 doxorubicin). Do not administer doxorubicin before dexrazoxane for injection. Administer doxorubicin within 30 minutes after the completion of dexrazoxane for injection infusion. 2.2 Dose Modifications Dosing in Patients with Renal Impairment Reduce dexrazoxane for injection dosage in patients with moderate to severe renal impairment (creatinine clearance values less than 40 mL/min) by 50% (dexrazoxane for injection to doxorubicin ratio reduced to 5:1; such as 250 mg/m 2 dexrazoxane for injection to 50 mg/m 2 doxorubicin) [see Use in Specific Populations (8.6 ) and Clinical Pharmacology (12.3 )] . Dosing in Patients with Hepatic Impairment Since a doxorubicin dose reduction is recommended in the presence of hyperbilirubinemia, reduce the dexrazoxane for injection dosage proportionately (maintaining the 10:1 ratio) in patients with hepatic impairment. 2.3 Preparation and Administration Preparation and Handling of Infusion Solution Reconstitute dexrazoxane for injection with Sterile Water for Injection, USP. Reconstitute with 25 mL for a dexrazoxane for injection 250 mg vial and 50 mL for a dexrazoxane for injection 500 mg vial to give a concentration of 10 mg/mL. Dilute the reconstituted solution further with Lactated Ringer’s Injection, USP to a concentration of 1.3 to 3.0 mg/mL in intravenous infusion bags for intravenous infusion. Following reconstitution with Sterile Water for Injection, USP, dexrazoxane for injection is stable for 30 minutes at room temperature or if storage is necessary, up to 3 hours from the time of reconstitution when stored under refrigeration, 2° to 8°C (36° to 46°F). The pH of the resultant solution is 1.0 to 3.0. DISCARD UNUSED SOLUTIONS. The diluted infusion solutions are stable for one hour at room temperature or if storage is necessary, up to 4 hours when stored under refrigeration, 2° to 8°C (36° to 46°F). The infusion solutions have a pH of 3.5 to 5.5. DISCARD UNUSED SOLUTIONS. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Solutions containing a precipitate should be discarded. Use caution when handling and preparing the reconstituted solution. The use of gloves is recommended. If dexrazoxane for injection powder or solutions contact the skin or mucosae, wash exposed area immediately and thoroughly with soap and water. Follow special handling and disposal procedures. 1 Administration Do not mix dexrazoxane for injection with other drugs. Administer the final diluted solution of dexrazoxane for injection by intravenous infusion over 15 minutes before the administration of doxorubicin. DO NOT ADMINISTER VIA AN INTRAVENOUS PUSH. Administer doxorubicin within 30 minutes after the completion of dexrazoxane for injection infusion.","2.1 Recommended Dose Administer dexrazoxane for injection via intravenous infusion over 15 minutes. DO NOT ADMINISTER VIA AN INTRAVENOUS PUSH. The recommended dosage ratio of dexrazoxane for injection to doxorubicin is 10:1 (e.g., 500 mg/m 2 dexrazoxane for injection to 50 mg/m 2 doxorubicin). Do not administer doxorubicin before dexrazoxane for injection. Administer doxorubicin within 30 minutes after the completion of dexrazoxane for injection infusion.","2.2 Dose Modifications Dosing in Patients with Renal Impairment Reduce dexrazoxane for injection dosage in patients with moderate to severe renal impairment (creatinine clearance values less than 40 mL/min) by 50% (dexrazoxane for injection to doxorubicin ratio reduced to 5:1; such as 250 mg/m 2 dexrazoxane for injection to 50 mg/m 2 doxorubicin) [see Use in Specific Populations (8.6 ) and Clinical Pharmacology (12.3 )] . Dosing in Patients with Hepatic Impairment Since a doxorubicin dose reduction is recommended in the presence of hyperbilirubinemia, reduce the dexrazoxane for injection dosage proportionately (maintaining the 10:1 ratio) in patients with hepatic impairment.","2.3 Preparation and Administration Preparation and Handling of Infusion Solution Reconstitute dexrazoxane for injection with Sterile Water for Injection, USP. Reconstitute with 25 mL for a dexrazoxane for injection 250 mg vial and 50 mL for a dexrazoxane for injection 500 mg vial to give a concentration of 10 mg/mL. Dilute the reconstituted solution further with Lactated Ringer’s Injection, USP to a concentration of 1.3 to 3.0 mg/mL in intravenous infusion bags for intravenous infusion. Following reconstitution with Sterile Water for Injection, USP, dexrazoxane for injection is stable for 30 minutes at room temperature or if storage is necessary, up to 3 hours from the time of reconstitution when stored under refrigeration, 2° to 8°C (36° to 46°F). The pH of the resultant solution is 1.0 to 3.0. DISCARD UNUSED SOLUTIONS. The diluted infusion solutions are stable for one hour at room temperature or if storage is necessary, up to 4 hours when stored under refrigeration, 2° to 8°C (36° to 46°F). The infusion solutions have a pH of 3.5 to 5.5. DISCARD UNUSED SOLUTIONS. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Solutions containing a precipitate should be discarded. Use caution when handling and preparing the reconstituted solution. The use of gloves is recommended. If dexrazoxane for injection powder or solutions contact the skin or mucosae, wash exposed area immediately and thoroughly with soap and water. Follow special handling and disposal procedures. 1 Administration Do not mix dexrazoxane for injection with other drugs. Administer the final diluted solution of dexrazoxane for injection by intravenous infusion over 15 minutes before the administration of doxorubicin. DO NOT ADMINISTER VIA AN INTRAVENOUS PUSH. Administer doxorubicin within 30 minutes after the completion of dexrazoxane for injection infusion."],"spl_product_data_elements":["Dexrazoxane Dexrazoxane DEXRAZOXANE HYDROCHLORIDE DEXRAZOXANE HYDROCHLORIC ACID Dexrazoxane Dexrazoxane DEXRAZOXANE HYDROCHLORIDE DEXRAZOXANE HYDROCHLORIC ACID"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS Dexrazoxane for injection (dexrazoxane for injection) is available in 250 mg or 500 mg single dose vials as sterile, pyrogen-free lyophilizates. 250 mg or 500 mg single dose vials as sterile, pyrogen-free lyophilizates. (3)"],"clinical_pharmacology_table":["<table cellspacing=\"0\" cellpadding=\"0\" border=\"0\"><col width=\"68.35pt\"/><col width=\"70.15pt\"/><col width=\"64.65pt\"/><col width=\"73.4pt\"/><col width=\"65.4pt\"/><col width=\"66.35pt\"/><col width=\"70.5pt\"/><tbody><tr><td styleCode=\" Botrule Toprule Lrule Rrule\"><paragraph>Dose</paragraph></td><td styleCode=\" Botrule Toprule Lrule Rrule\"><paragraph>Dose</paragraph></td><td styleCode=\" Botrule Toprule Lrule Rrule\"><paragraph>Number of</paragraph></td><td styleCode=\" Botrule Toprule Lrule Rrule\"><paragraph>Elimination</paragraph></td><td styleCode=\" Botrule Toprule Lrule Rrule\"><paragraph>Plasma</paragraph></td><td styleCode=\" Botrule Toprule Lrule Rrule\"><paragraph>Renal</paragraph></td><td styleCode=\" Botrule Toprule Lrule Rrule\"><paragraph>bVolume of</paragraph></td></tr><tr><td><paragraph>Doxorubicin (mg/m2)</paragraph></td><td><paragraph>Dexrazoxane</paragraph><paragraph>(mg/m2)</paragraph></td><td><paragraph>Subjects</paragraph></td><td><paragraph>Half-Life (h)</paragraph></td><td><paragraph>Clearance (L/h/m2)</paragraph></td><td><paragraph>Clearance (L/h/m2)</paragraph></td><td><paragraph>Distribution (L/m2)</paragraph></td></tr><tr><td styleCode=\" Botrule Toprule Lrule Rrule\"><paragraph>50</paragraph></td><td styleCode=\" Botrule Toprule Lrule Rrule\"><paragraph>500</paragraph></td><td styleCode=\" Botrule Toprule Lrule Rrule\"><paragraph>10</paragraph></td><td styleCode=\" Botrule Toprule Lrule Rrule\"><paragraph>2.5 (16)</paragraph></td><td styleCode=\" Botrule Toprule Lrule Rrule\"><paragraph>7.88 (18)</paragraph></td><td styleCode=\" Botrule Toprule Lrule Rrule\"><paragraph>3.35 (36)</paragraph></td><td styleCode=\" Botrule Toprule Lrule Rrule\"><paragraph>22.4 (22)</paragraph></td></tr><tr><td><paragraph>60</paragraph></td><td><paragraph>600</paragraph></td><td><paragraph>5</paragraph></td><td><paragraph>2.1 (29)</paragraph></td><td><paragraph>6.25 (31)</paragraph></td><td><paragraph>&#x2014;</paragraph></td><td><paragraph>22.0 (55)</paragraph></td></tr></tbody></table>"],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATIONS Nursing Mothers: Discontinue drug or nursing. (8.3) 8.1 Pregnancy Teratogenic Effects. Pregnancy Category D Risk Summary Dexrazoxane for injection can cause fetal harm when administered to pregnant women. Dexrazoxane administration resulted in maternal toxicity, embryotoxicity and teratogenicity in rats and rabbits at doses significantly lower than the clinically recommended dose. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see Warnings and Precautions (5.5)] . Animal Data Dexrazoxane resulted in maternal toxicity in rats at doses of ≥2 mg/kg (1/40 the human dose on a mg/m 2 basis) and embryotoxicity and teratogenicity at 8 mg/kg (approximately 1/10 the human dose on a mg/m 2 basis) when given daily to pregnant rats during the period of organogenesis. Teratogenic effects in the rat included imperforate anus, microphthalmia, and anophthalmia. In offspring allowed to develop to maturity, fertility was impaired in the male and female rats treated in utero during organogenesis at 8 mg/kg. In rabbits, doses of ≥5 mg/kg (approximately 1/10 the human dose on a mg/m 2 basis) daily during the period of organogenesis caused maternal toxicity and doses of 20 mg/kg (1/2 the human dose on a mg/m 2 basis) were embryotoxic and teratogenic. Teratogenic effects in the rabbit included several skeletal malformations such as short tail, rib and thoracic malformations, and soft tissue variations including subcutaneous, eye and cardiac hemorrhagic areas, as well as agenesis of the gallbladder and of the intermediate lobe of the lung. 8.3 Nursing Mothers It is not known whether dexrazoxane or its metabolites are excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from dexrazoxane, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. 8.4 Pediatric Use The safety and effectiveness of dexrazoxane in pediatric patients have not been established [see Warnings and Precautions (5.4)] . 8.5 Geriatric Use Clinical studies of dexrazoxane for injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. 8.6 Females of Reproductive Potential Contraception Dexrazoxane for injection can cause fetal harm when administered during pregnancy. Advise female patients of reproductive potential to use highly effective contraception during treatment [see Use in Specific Populations (8.1 )] . 8.7 Renal Impairment Greater exposure to dexrazoxane may occur in patients with compromised renal function. Reduce the dexrazoxane for injection dose by 50% in patients with creatinine clearance values <40 mL/min [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3 )] .","8.6 Females of Reproductive Potential Contraception Dexrazoxane for injection can cause fetal harm when administered during pregnancy. Advise female patients of reproductive potential to use highly effective contraception during treatment [see Use in Specific Populations (8.1 )] ."],"package_label_principal_display_panel":["Vial Label 250 mg NDC 0143-9247-01 Rx only Dexrazoxane for Injection 250 mg per vial For Intravenous use ONLY STERILE, PYROGEN-FREE, LYOPHILIZATE Single Dose Vial vial","Carton 250 mg NDC 0143-9247-01 Rx only Dexrazoxane for Injection 250 mg per vial For Intravenous use ONLY STERILE, PYROGEN-FREE, LYOPHILIZATE Single Dose Vial carton","Vial Label 500 mg NDC 0143-9248-01 Rx only Dexrazoxane for Injection 500 mg per vial For Intravenous use ONLY STERILE, PYROGEN-FREE, LYOPHILIZATE Single Dose Vial vial","Carton 500 mg NDC 0143-9248-01 Rx only Dexrazoxane for Injection 500 mg per vial For Intravenous use ONLY STERILE, PYROGEN-FREE, LYOPHILIZATE Single Dose Vial carton"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["13.1 Carcinogenesis and Mutagenesis and Impairment of Fertility No long-term carcinogenicity studies have been carried out with dexrazoxane in animals. Nevertheless, a study by the National Cancer Institute has reported that long-term dosing with razoxane (the racemic mixture of dexrazoxane, ICRF-187, and its enantiomer ICRF-186) is associated with the development of malignancies in rats and possibly in mice [see Warnings and Precautions (5.4 )] . Dexrazoxane was not mutagenic in the bacterial reverse mutation (Ames) test, but was found to be clastogenic to human lymphocytes in vitro and to mouse bone marrow erythrocytes in vivo (micronucleus test). Dexrazoxane for injection has the potential to impair fertility in male patients based on effects in repeat-dose toxicology studies. Testicular atrophy was seen with dexrazoxane administration at doses as low as 30 mg/kg weekly for 6 weeks in rats (1/3 the human dose on a mg/m 2 basis) and as low as 20 mg/kg weekly for 13 weeks in dogs (approximately equal to the human dose on a mg/m 2 basis)."]},"tags":[{"label":"Cytoprotective Agent","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"DNA topoisomerase 2-alpha","category":"target"},{"label":"TOP2A","category":"gene"},{"label":"TOP2B","category":"gene"},{"label":"V03AF02","category":"atc"},{"label":"Intravenous","category":"route"},{"label":"Injection","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Mature","category":"status"},{"label":"Doxorubicin Induced Cardiomyopathy","category":"indication"},{"label":"Extravasation Injury from Anthracycline Injection","category":"indication"},{"label":"Prevention of CMV Disease After Organ Transplant","category":"indication"},{"label":"Pfizer","category":"company"},{"label":"Approved 1990s","category":"decade"},{"label":"Antineoplastic Agents","category":"pharmacology"},{"label":"Cardiotonic Agents","category":"pharmacology"},{"label":"Cardiovascular Agents","category":"pharmacology"},{"label":"Enzyme Inhibitors","category":"pharmacology"},{"label":"Protective Agents","category":"pharmacology"},{"label":"Topoisomerase II Inhibitors","category":"pharmacology"},{"label":"Topoisomerase Inhibitors","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"FEBRILE NEUTROPENIA","source":"FDA FAERS","actionTaken":"137 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"129 reports"},{"date":"","signal":"NEUTROPENIA","source":"FDA FAERS","actionTaken":"103 reports"},{"date":"","signal":"PRODUCT USE ISSUE","source":"FDA FAERS","actionTaken":"53 reports"},{"date":"","signal":"PYREXIA","source":"FDA FAERS","actionTaken":"52 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"42 reports"},{"date":"","signal":"MYELOSUPPRESSION","source":"FDA FAERS","actionTaken":"41 reports"},{"date":"","signal":"WHITE BLOOD CELL COUNT DECREASED","source":"FDA FAERS","actionTaken":"39 reports"},{"date":"","signal":"VOMITING","source":"FDA FAERS","actionTaken":"36 reports"},{"date":"","signal":"PLATELET COUNT DECREASED","source":"FDA FAERS","actionTaken":"35 reports"}],"commonSideEffects":[{"effect":"Alopecia","drugRate":"94%","severity":"serious","_validated":true},{"effect":"Nausea","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Vomiting","drugRate":"59%","severity":"serious","_validated":true},{"effect":"Fatigue/Malaise","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Anorexia","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Stomatitis","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Fever","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Infection","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Diarrhea","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Pain on Injection","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Sepsis","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Neurotoxicity","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Streaking/Erythema","drugRate":"","severity":"mild","_validated":false,"_confidence":0.3},{"effect":"Phlebitis","drugRate":"","severity":"mild","_validated":false,"_confidence":0.3},{"effect":"Esophagitis","drugRate":"","severity":"mild","_validated":false,"_confidence":0.3},{"effect":"Dysphagia","drugRate":"","severity":"mild","_validated":false,"_confidence":0.3},{"effect":"Hemorrhage","drugRate":"","severity":"mild","_validated":false,"_confidence":0.3},{"effect":"Extravasation","drugRate":"","severity":"mild","_validated":false,"_confidence":0.3},{"effect":"Urticaria","drugRate":"","severity":"mild","_validated":false,"_confidence":0.3},{"effect":"Recall Skin Reaction","drugRate":"","severity":"mild","_validated":false,"_confidence":0.3}],"contraindications":["Bone marrow depression","Impaired renal function disorder","Non-infective meningitis"],"specialPopulations":{"Lactation":"Because of the potential for serious adverse reactions, such as myelosuppression, in breastfed child from Totect, advise women not to breastfeed during treatment and for weeks following the final dose of Totect.","Pregnancy":"Dexrazoxane for injection can cause fetal harm when administered to pregnant women. Dexrazoxane administration resulted in maternal toxicity, embryotoxicity and teratogenicity in rats and rabbits at doses significantly lower than the clinically recommended dose. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to fetus.","Geriatric use":"Clinical studies of dexrazoxane for injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant diseases or other drug therapy.","Paediatric use":"The safety and effectiveness of dexrazoxane in pediatric patients have not been established","Hepatic impairment":"In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant diseases or other drug therapy."}},"trials":[],"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=DEXRAZOXANE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:47:28.533140+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:47:40.307704+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T03:47:27.175306+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=DEXRAZOXANE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:47:41.050922+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:47:26.121743+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:47:26.121760+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T03:47:42.587995+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: DNA topoisomerase II inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:47:41.636434+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1738/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:47:41.526420+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA076068","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:47:26.121763+00:00"}},"allNames":"zinecard","offLabel":[],"synonyms":["dexrazoxane","zinecard","savene","totect","dexrazoxane hydrochloride","dexrazoxane HCl"],"timeline":[{"date":"1995-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from PHARMACIA AND UPJOHN to Pfizer"},{"date":"1995-05-26","type":"positive","source":"DrugCentral","milestone":"FDA approval (Pharmacia And Upjohn)"},{"date":"2007-09-06","type":"positive","source":"FDA Orange Book","milestone":"Totect approved — EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"},{"date":"2019-12-16","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 3 manufacturers approved"}],"aiSummary":"Zinecard (Dexrazoxane) is a cytoprotective agent developed by Pharmacia and Upjohn, now owned by Pfizer. It targets DNA topoisomerase 2-alpha to prevent cardiomyopathy and extravasation injury caused by anthracycline injection. Zinecard is approved for the prevention of CMV disease after organ transplant and is available as a generic medication. The drug has a half-life of 2.5 hours and is off-patent, with no active Orange Book patents. Key safety considerations include potential nephrotoxicity and hepatotoxicity.","approvals":[{"date":"1995-05-26","orphan":true,"company":"PHARMACIA AND UPJOHN","regulator":"FDA"}],"brandName":"Zinecard","ecosystem":[{"indication":"Doxorubicin Induced Cardiomyopathy","otherDrugs":[],"globalPrevalence":null},{"indication":"Extravasation Injury from Anthracycline Injection","otherDrugs":[],"globalPrevalence":null},{"indication":"Prevention of CMV Disease After Organ Transplant","otherDrugs":[{"name":"ganciclovir","slug":"ganciclovir","company":"Roche Palo"},{"name":"misoprostol","slug":"misoprostol","company":"Gd Searle Llc"}],"globalPrevalence":null}],"mechanism":{"target":"DNA topoisomerase 2-alpha","novelty":"Follow-on","targets":[{"gene":"TOP2A","source":"DrugCentral","target":"DNA topoisomerase 2-alpha","protein":"DNA topoisomerase 2-alpha"},{"gene":"TOP2B","source":"DrugCentral","target":"DNA topoisomerase 2-beta","protein":"DNA topoisomerase 2-beta"}],"modality":"Small Molecule","drugClass":"Cytoprotective Agent","explanation":"The mechanism by which dexrazoxane reduces tissue damage caused by anthracycline-related cardiomyopathy or following anthracycline extravasation is not fully understood. Dexrazoxane is cyclic derivative of EDTA that penetrates cell membranes. Results of laboratory studies suggest that dexrazoxane is converted intracellularly to ring-opened chelating agent that interferes with iron-mediated free radical generation. Some evidence suggests that dexrazoxane inhibits topoisomerase II reversibly.","oneSentence":"Zinecard works by binding to metal ions and preventing them from causing damage to DNA during anthracycline treatment.","technicalDetail":"Zinecard (Dexrazoxane) acts as a chelating agent, binding to metal ions such as iron and copper, which are released during anthracycline treatment, thereby preventing them from interacting with DNA topoisomerase 2-alpha and inducing DNA strand breaks.","_target_confidence":0.5},"commercial":{"launchDate":"1995","_launchSource":"DrugCentral (FDA 1995-05-26, PHARMACIA AND UPJOHN)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/839","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=DEXRAZOXANE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=DEXRAZOXANE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T10:32:27.893968","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:47:47.477106+00:00","fieldsConflicting":19,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"mesna","drugSlug":"mesna","fdaApproval":"1988-12-30","genericCount":9,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"leucovorin","drugSlug":"leucovorin","fdaApproval":"1952-06-20","patentExpiry":"Dec 23, 2044","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"levofolinic acid","drugSlug":"levofolinic-acid","fdaApproval":"2008-03-07","relationship":"same-class"},{"drugName":"amifostine","drugSlug":"amifostine","fdaApproval":"1995-12-08","genericCount":2,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"rasburicase","drugSlug":"rasburicase","fdaApproval":"2002-07-12","relationship":"same-class"},{"drugName":"palifermin","drugSlug":"palifermin","fdaApproval":"2004-12-15","relationship":"same-class"},{"drugName":"glucarpidase","drugSlug":"glucarpidase","fdaApproval":"2012-01-17","relationship":"same-class"},{"drugName":"arginine","drugSlug":"arginine","fdaApproval":"1973-02-28","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"lysine","drugSlug":"lysine","fdaApproval":"","relationship":"same-class"},{"drugName":"trilaciclib","drugSlug":"trilaciclib","fdaApproval":"2021-02-12","patentExpiry":"Oct 25, 2031","patentStatus":"Patent protected","relationship":"same-class"}],"genericName":"dexrazoxane","indications":{"approved":[{"name":"Doxorubicin Induced Cardiomyopathy","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":{"women":true,"metastatic breast cancer":true,"continuing doxorubicin therapy":true,"cumulative doxorubicin dose of 300 mg/m2":true}},{"name":"Extravasation Injury from Anthracycline Injection","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":{}},{"name":"Prevention of CMV Disease After Organ Transplant","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":{}}],"offLabel":[],"pipeline":[]},"currentOwner":"Pfizer","drugCategory":"mature","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"mesna","brandName":"mesna","genericName":"mesna","approvalYear":"1988","relationship":"same-class"},{"drugId":"leucovorin","brandName":"leucovorin","genericName":"leucovorin","approvalYear":"1952","relationship":"same-class"},{"drugId":"levofolinic-acid","brandName":"levofolinic acid","genericName":"levofolinic acid","approvalYear":"2008","relationship":"same-class"},{"drugId":"amifostine","brandName":"amifostine","genericName":"amifostine","approvalYear":"1995","relationship":"same-class"},{"drugId":"rasburicase","brandName":"rasburicase","genericName":"rasburicase","approvalYear":"2002","relationship":"same-class"},{"drugId":"palifermin","brandName":"palifermin","genericName":"palifermin","approvalYear":"2004","relationship":"same-class"},{"drugId":"glucarpidase","brandName":"glucarpidase","genericName":"glucarpidase","approvalYear":"2012","relationship":"same-class"},{"drugId":"arginine","brandName":"arginine","genericName":"arginine","approvalYear":"1973","relationship":"same-class"},{"drugId":"lysine","brandName":"lysine","genericName":"lysine","approvalYear":"","relationship":"same-class"},{"drugId":"trilaciclib","brandName":"trilaciclib","genericName":"trilaciclib","approvalYear":"2021","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT00980460","phase":"PHASE3","title":"Risk-Based 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Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma","status":"RECRUITING","sponsor":"University of Colorado, Denver","startDate":"2026-12","conditions":["Sarcoma"],"enrollment":20,"completionDate":"2029-12"},{"nctId":"NCT03164057","phase":"PHASE2","title":"A Trial of Epigenetic Priming in Patients With Newly Diagnosed Acute Myeloid Leukemia","status":"ACTIVE_NOT_RECRUITING","sponsor":"St. Jude Children's Research Hospital","startDate":"2017-06-15","conditions":["Acute Myeloid Leukemia","Myelodysplastic Syndromes"],"enrollment":206,"completionDate":"2027-06"},{"nctId":"NCT01231906","phase":"PHASE3","title":"Combination Chemotherapy in Treating Patients With Non-Metastatic Extracranial Ewing Sarcoma","status":"COMPLETED","sponsor":"Children's Oncology Group","startDate":"2010-11-24","conditions":["Localized Extraskeletal Ewing Sarcoma","Peripheral Primitive Neuroectodermal Tumor of Bone","Peripheral Primitive Neuroectodermal Tumor of Soft 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Neuroblastoma"],"enrollment":42,"completionDate":"2026-09-19"},{"nctId":"NCT06262438","phase":"PHASE2","title":"CHIP-AML22/Quizartinib: Quizartinib + Chemotherapy in Newly Diagnosed Pediatric FLT3-ITD+ and NPM1wt AML Patients","status":"RECRUITING","sponsor":"Princess Maxima Center for Pediatric Oncology","startDate":"2024-02-06","conditions":["Acute Myeloid Leukemia in Children"],"enrollment":60,"completionDate":"2032-06"},{"nctId":"NCT05858710","phase":"PHASE1","title":"Study of DPPG2-TSL-DOX Combined With Hyperthermia in Soft Tissue Sarcoma","status":"COMPLETED","sponsor":"Thermosome GmbH","startDate":"2023-04-19","conditions":["Sarcoma, Soft Tissue"],"enrollment":8,"completionDate":"2025-05-28"},{"nctId":"NCT03930680","phase":"PHASE1","title":"Prevention of Heart Failure Induced by Doxorubicin With Early Administration of Dexrazoxane","status":"COMPLETED","sponsor":"University of Arkansas","startDate":"2021-09-14","conditions":["Degradation of Top2b and Top2a in Human by 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