{"id":"apalutamide","rwe":[],"_fda":{"id":"8d917bea-59a6-4338-b818-6ad5c62d02f9","set_id":"d1cda4f7-cb33-46ea-b9ac-431f6452b1a5","openfda":{"unii":["4T36H88UA7"],"route":["ORAL"],"rxcui":["1999581","1999587","2630215","2630217"],"spl_id":["8d917bea-59a6-4338-b818-6ad5c62d02f9"],"brand_name":["ERLEADA"],"spl_set_id":["d1cda4f7-cb33-46ea-b9ac-431f6452b1a5"],"package_ndc":["59676-600-12","59676-600-99","59676-600-56","59676-604-30","59676-604-14"],"product_ndc":["59676-600","59676-604"],"generic_name":["APALUTAMIDE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["APALUTAMIDE"],"manufacturer_name":["Janssen Products, LP"],"application_number":["NDA210951"],"is_original_packager":[true]},"version":"28","pregnancy":["8.1 Pregnancy Risk Summary The safety and efficacy of ERLEADA have not been established in females. Based on findings from animals and its mechanism of action, ERLEADA can cause fetal harm and loss of pregnancy when administered to a pregnant female [see Clinical Pharmacology (12.1) ] . There are no available data on ERLEADA use in pregnant women to inform a drug-associated risk. In an animal reproduction study, oral administration of apalutamide to pregnant rats during and after organogenesis resulted in fetal abnormalities and embryo-fetal lethality at maternal exposures ≥ 2 times the human clinical exposure (AUC) at the recommended dose (see Data ) . Data Animal Data In a pilot embryo-fetal developmental toxicity study in rats, apalutamide caused developmental toxicity when administered at oral doses of 25, 50 or 100 mg/kg/day throughout and after the period of organogenesis (gestational days 6–20). Findings included embryo-fetal lethality (resorptions) at doses ≥50 mg/kg/day, decreased fetal anogenital distance, misshapen pituitary gland, and skeletal variations (unossified phalanges, supernumerary short thoracolumbar rib(s), and small, incomplete ossification, and/or misshapen hyoid bone) at ≥25 mg/kg/day. A dose of 100 mg/kg/day caused maternal toxicity. The doses tested in rats resulted in systemic exposures (AUC) approximately 2, 4 and 6 times, respectively, the AUC in patients."],"overdosage":["10 OVERDOSAGE There is no known specific antidote for apalutamide overdose. In the event of an overdose, stop ERLEADA, undertake general supportive measures until clinical toxicity has been diminished or resolved."],"description":["11 DESCRIPTION Apalutamide, the active ingredient of ERLEADA, is an androgen receptor inhibitor. Each ERLEADA tablet contains either 60 mg or 240 mg of apalutamide. The chemical name is (4-[7-(6-Cyano-5-trifluoromethylpyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspiro[3.4]oct-5-yl]-2-fluoro-N-methylbenzamide). Apalutamide is a white to slightly yellow powder. Apalutamide is practically insoluble in aqueous media over a wide range of pH values. The molecular weight is 477.44 and molecular formula is C 21 H 15 F 4 N 5 O 2 S. The structural formula is: ERLEADA ® (apalutamide) tablets are available in 240 mg tablets and 60 mg tablets with the following inactive ingredients: 240 mg film-coated tablets: colloidal anhydrous silica, croscarmellose sodium, hydroxypropyl methylcellulose-acetate succinate, silicified microcrystalline cellulose, and magnesium stearate. The coating contains glyceryl monocaprylocaprate, iron oxide black, polyvinyl alcohol, talc, titanium dioxide, and vinyl alcohol grafted copolymer. 60 mg film-coated tablets: colloidal anhydrous silica, croscarmellose sodium, hydroxypropyl methylcellulose-acetate succinate, magnesium stearate, microcrystalline cellulose, and silicified microcrystalline cellulose. The coating contains iron oxide black, iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Chemical Structure"],"how_supplied":["16 HOW SUPPLIED/STORAGE AND HANDLING ERLEADA ® (apalutamide) tablets are available in the strengths and packages listed below: ERLEADA ® 240 mg Tablets Film coated, bluish grey to grey, oval-shaped tablets debossed with \"E240\" on one side. NDC Number 59676‐604‐30 - 30 tablets available in bottles with a silica gel desiccant and has a child-resistant closure ERLEADA ® 60 mg Tablets Film coated, slightly yellowish to greyish green, oblong-shaped tablets debossed with \"AR 60\" on one side. NDC Number 59676‐600‐12 - 120 tablets available in bottles with a silica gel desiccant and has a child-resistant closure Storage and Handling Store at 20 °C to 25 °C (68 °F to 77 °F); excursions permitted to 15 °C to 30 °C (59 °F to 86 °F) [see USP Controlled Room Temperature] . Store in original package to protect from light and moisture. Do not discard desiccant."],"geriatric_use":["8.5 Geriatric Use Of the 1327 patients who received ERLEADA in clinical studies, 19% of patients were less than 65 years, 41% of patients were 65 years to 74 years, and 40% were 75 years and over. No overall differences in effectiveness were observed between older and younger patients. Of patients treated with ERLEADA (n=1073), Grade 3–4 adverse reactions occurred in 39% of patients younger than 65 years, 41% of patients 65–74 years, and 49% of patients 75 years or older. Falls in patients receiving ERLEADA with androgen deprivation therapy was elevated in the elderly, occurring in 8% of patients younger than 65 years, 10% of patients 65–74 years, and 19% of patients 75 years or older."],"pediatric_use":["8.4 Pediatric Use Safety and effectiveness of ERLEADA in pediatric patients have not been established."],"effective_time":"20260310","clinical_studies":["14 CLINICAL STUDIES The efficacy and safety of ERLEADA was established in two randomized placebo-controlled clinical trials. TITAN (NCT02489318): Metastatic Castration-sensitive Prostate Cancer (mCSPC) TITAN was a randomized, double-blind, placebo-controlled, multinational, clinical trial in which 1052 patients with mCSPC were randomized (1:1) to receive either ERLEADA orally at a dose of 240 mg once daily (N=525) or placebo once daily (N=527). All patients in the TITAN trial received concomitant GnRH analog or had prior bilateral orchiectomy. Patients were stratified by Gleason score at diagnosis, prior docetaxel use, and region of the world. Patients with both high- and low-volume mCSPC were eligible for the study. High volume of disease was defined as metastases involving the viscera with 1 bone lesion or the presence of 4 or more bone lesions, at least 1 of which must be in a bony structure beyond the vertebral column and pelvic bones. The following patient demographics and baseline disease characteristics were balanced between the treatment arms. The median age was 68 years (range 43–94) and 23% of patients were 75 years of age or older. The racial distribution was 68% Caucasian, 22% Asian, and 2% Black. Sixty-three percent (63%) of patients had high-volume disease and 37% had low-volume disease. Sixteen percent (16%) of patients had prior surgery, radiotherapy of the prostate or both. A majority of patients had a Gleason score of 8 or higher (67%). Sixty-eight percent (68%) of patients received prior treatment with an anti-androgen (bicalutamide, flutamide, or nilutamide). All patients except one in the placebo group, had an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1 at study entry. The major efficacy outcome measures of the study were overall survival (OS) and radiographic progression-free survival (rPFS). Radiographic progression-free survival was based on investigator assessment and was defined as time from randomization to radiographic disease progression or death. Radiographic disease progression was defined by identification of 2 or more new bone lesions on a bone scan with confirmation (Prostate Cancer Working Group 2 criteria) and/or progression in soft tissue disease. A statistically significant improvement in OS and rPFS was demonstrated in patients randomized to receive ERLEADA compared with patients randomized to receive placebo. The results for OS are based upon a prespecified interim efficacy analysis. An updated OS analysis was conducted at the time of final study analysis when 405 deaths were observed. The median follow-up time was 44 months. Thirty-nine percent of patients in the placebo arm crossed over to receive ERLEADA. Efficacy results of TITAN are summarized in Table 5 and Figures 1 and 2. Table 5: Efficacy Results from the TITAN Study Endpoint ERLEADA (N=525) Placebo (N=527) Primary Overall Survival Interim analysis is based on 50% of the number of events planned for the final analysis. Allocated alpha = 0.01. Deaths (%) 83 (16%) 117 (22%) Median, months (95% CI) NE=Not Estimable NE (NE, NE) NE (NE, NE) Hazard Ratio (95% CI) Hazard ratio is from stratified proportional hazards model. Hazard ratio <1 favors ERLEADA. 0.67 (0.51, 0.89) p-value p-value is from the log-rank test stratified by Gleason score at diagnosis (≤7 vs. >7), Region (NA/EU vs. Other Countries) and Prior docetaxel use (Yes vs. No). 0.0053 Updated Overall Survival Deaths (%) 170 (32%) 235 (45%) Median, months (95% CI) NE (NE, NE) 52 (42, NE) Hazard Ratio (95% CI) 0.65 (0.53, 0.79) Radiographic Progression-free Survival Disease progression or death (%) 134 (26%) 231 (44%) Median, months (95% CI) NE (NE, NE) 22.1 (18, 33) Hazard Ratio (95% CI) 0.48 (0.39, 0.60) p-value <0.0001 Consistent improvement in rPFS was observed across the following patient subgroups: disease volume (high vs low), prior docetaxel use (yes or no), and Gleason score at diagnosis (≤7 vs. >7). Consistent improvement in OS was observed across the following patient subgroups: disease volume (high vs low) and Gleason score at diagnosis (≤7 vs. >7). Treatment with ERLEADA resulted in a statistically significant delay in the initiation of cytotoxic chemotherapy (HR = 0.39, 95% CI = 0.27, 0.56; p < 0.0001). Figure 1: Kaplan-Meier Plot of Updated Overall Survival (OS); Intent-to-treat mCSPC Population (TITAN) Figure 2: Kaplan-Meier Plot of Radiographic Progression-Free Survival (rPFS); Intent-to-treat mCSPC Population (TITAN) Figure 1 Figure 2 SPARTAN (NCT01946204): Non-metastatic, Castration-resistant Prostate Cancer (nmCRPC) SPARTAN was a multicenter, double-blind, randomized (2:1), placebo-controlled clinical trial in which 1207 patients with nmCRPC were randomized (2:1) to receive either ERLEADA orally at a dose of 240 mg once daily (N=806) or placebo once daily (N=401). All patients in the SPARTAN trial received a concomitant GnRH analog or had a bilateral orchiectomy. Patients were stratified by Prostate Specific Antigen (PSA) Doubling Time (PSADT), the use of bone-sparing agents, and locoregional disease. Patients were required to have a PSADT ≤ 10 months and confirmation of non-metastatic disease by blinded independent central review (BICR). PSA results were blinded and were not used for treatment discontinuation. Patients randomized to either arm discontinued treatment for radiographic disease progression confirmed by BICR, locoregional-only progression, initiation of new treatment, unacceptable toxicity, or withdrawal. The following patient demographics and baseline disease characteristics were balanced between the treatment arms. The median age was 74 years (range 48–97) and 26% of patients were 80 years of age or older. The racial distribution was 66% Caucasian, 12% Asian, and 6% Black. Seventy-seven percent (77%) of patients in both treatment arms had prior surgery or radiotherapy of the prostate. A majority of patients had a Gleason score of 7 or higher (78%). Fifteen percent (15%) of patients had <2 cm pelvic lymph nodes at study entry. Seventy-three percent (73%) of patients received prior treatment with an anti-androgen; 69% of patients received bicalutamide and 10% of patients received flutamide. All patients had an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1 at study entry. The major efficacy outcome measure of the study was metastasis-free survival (MFS), defined as the time from randomization to the time of first evidence of BICR-confirmed distant metastasis, defined as new bone or soft tissue lesions or enlarged lymph nodes above the iliac bifurcation, or death due to any cause, whichever occurred first. Additional efficacy endpoints were time to metastasis (TTM), progression-free survival (PFS) which also includes locoregional progression, time to symptomatic progression, overall survival (OS), and time to initiation of cytotoxic chemotherapy. A statistically significant improvement in MFS and OS was demonstrated in patients randomized to receive ERLEADA compared with patients randomized to receive placebo. The major efficacy outcome (MFS) was supported by improvements in TTM and PFS. The final analysis of OS and time to initiation of cytotoxic chemotherapy was conducted 32 months after the analysis of MFS, TTM and PFS. The efficacy results from SPARTAN are summarized in Table 6 and Figures 3 and 4. Table 6: Efficacy Results from the SPARTAN Study Endpoint ERLEADA (N=806) Placebo (N=401) Metastasis Free Survival All analyses stratified by PSA doubling time, bone-sparing agent use, and locoregional disease status. , Confirmed responses assessed by BICR. , Locoregional-only progression is observed in 2.4% of patients overall. Number of Events (%) 184 (23%) 194 (48%) Median, months (95% CI) NE=Not Estimable 40.5 (NE, NE) 16.2 (15, 18) Hazard Ratio (95% CI) 0.28 (0.23, 0.35) p-value <0.0001 Time to Metastasis , Number of Events (%) 175 (22%) 191 (48%) Median, months (95% CI) 40.5 (NE, NE) 16.6 (15, 18) Hazard Ratio (95% CI) 0.27 (0.22, 0.34) p-value <0.0001 Progression-Free Survival , Number of Events (%) 200 (25%) 204 (51%) Median, months (95% CI) 40.5 (NE, NE) 14.7 (14, 18) Hazard Ratio (95% CI) 0.29 (0.24, 0.36) p-value <0.0001 Overall Survival Number of Events (%) 274 (34%) 154 (38%) Median, months (95% CI) 73.9 (61, NE) 59.9 (53, NE) Hazard Ratio (95% CI) 0.78 (0.64, 0.96) p-value 0.0161 Consistent results for MFS were observed across patient subgroups including PSADT (≤ 6 months or > 6 months), use of a prior bone-sparing agent (yes or no), and locoregional disease (N0 or N1). Treatment with ERLEADA resulted in a statistically significant delay in the initiation of cytotoxic chemotherapy [HR = 0.63 (95% CI: 0.49, 0.81), p=0.0002]. Figure 3: Kaplan-Meier Metastasis-Free Survival (MFS) Curve in SPARTAN (nmCRPC) Figure 4: Kaplan-Meier Overall Survival (OS) Curve in SPARTAN (nmCRPC) Figure 3 Figure 4"],"pharmacodynamics":["12.2 Pharmacodynamics ERLEADA 240 mg daily in addition to ADT in patients with mCSPC (TITAN) reduced PSA to undetectable levels (<0.2 ng/mL) in 68% of patients compared to 32% of patients taking ADT alone. ERLEADA 240 mg daily in addition to ADT in patients with nmCRPC (SPARTAN) reduced PSA to undetectable levels (<0.2 ng/mL) in 38% of patients compared to no patients (0%) taking ADT alone. The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of apalutamide have not been fully characterized. Cardiac Electrophysiology At the approved recommended dosage, the maximum mean QTcF change from baseline was 12.4 ms (2-sided 90% upper CI: 16.0 ms). An exposure-QT analysis suggested a concentration-dependent increase in QTcF for apalutamide and its active metabolite."],"pharmacokinetics":["12.3 Pharmacokinetics Apalutamide and N-desmethyl apalutamide pharmacokinetic parameters were observed at steady state following the approved recommended dosage for ERLEADA and are presented as the mean [standard deviation (SD)] unless otherwise specified. Apalutamide maximum concentration (C max ) is 6 mcg/mL (1.7) and total systemic exposure (AUC) is 100 mcg∙h/mL (32). Apalutamide C max and AUC increases in a dose proportional manner following repeated once-daily dosing of 30 to 480 mg (0.125 to 2 times the recommended dosage). Apalutamide steady-state is achieved after 4 weeks and the mean accumulation ratio is approximately 5-fold. The major active metabolite N-desmethyl apalutamide C max is 5.9 mcg/mL (1) and AUC is 124 mcg∙h/mL (23). Mean AUC metabolite/parent drug ratio for N-desmethyl apalutamide following repeat-dose administration is 1.3. Based on systemic exposure, relative potency, and pharmacokinetic properties, N-desmethyl apalutamide likely contributes to the clinical activity of apalutamide. Absorption Apalutamide absolute oral bioavailability is approximately 100%. Apalutamide median (min, max) time to maximum plasma concentration (t max ) is 2 hours (1, 5 hours). No clinically significant changes in C max and AUC were observed following oral administration of four 60 mg tablets dispersed in applesauce compared to administration of four intact 60 mg tablets under fasting condition. Effect of Food No clinically significant differences in apalutamide C max and AUC were observed following administration of a high-fat meal (approximately 500 to 600 fat calories, 250 carbohydrate calories, and 150 protein calories). Median time to reach t max was delayed approximately 2 hours with food. Distribution Apalutamide apparent volume of distribution is approximately 276 L. Apalutamide is 96% and N-desmethyl apalutamide is 95% bound to plasma proteins with no concentration dependency. Elimination Apalutamide half-life is approximately 3 days. The CL/F of apalutamide is 1.3 L/h after single dosing and increases to 2.0 L/h at steady-state after once-daily dosing likely due to CYP3A4 auto-induction. Metabolism Apalutamide is primarily metabolized by CYP2C8 and CYP3A4 to form active metabolite, N-desmethyl apalutamide. The contribution of CYP2C8 and CYP3A4 in the metabolism of apalutamide is estimated to be 58% and 13% following single dose but changes to 40% and 37%, respectively at steady-state. Apalutamide represented 45% and N-desmethyl apalutamide represented 44% of the total AUC following a single oral administration of radiolabeled apalutamide 240 mg. Excretion Up to 70 days following a single oral administration of radiolabeled apalutamide, 65% of the dose was recovered in urine (1.2% of dose as unchanged apalutamide and 2.7% as N-desmethyl apalutamide) and 24% was recovered in feces (1.5% of dose as unchanged apalutamide and 2% as N-desmethyl apalutamide). Specific Populations No clinically significant differences in the pharmacokinetics of apalutamide or N-desmethyl apalutamide were observed based on age (18-94 years), race (Black, non-Japanese Asian, Japanese), or eGFR 30-89 mL/min/1.73 m 2 (estimated by MDRD equation). The effect of eGFR ≤29 mL/min/1.73 m 2 on apalutamide pharmacokinetics is unknown. Patients with Hepatic Impairment In subjects with severe hepatic impairment (Child-Pugh C), AUC for the active moieties (sum of unbound apalutamide plus the potency-adjusted unbound N-desmethyl apalutamide) increased 2.1-fold compared to subjects with normal hepatic function. In subjects with mild to moderate hepatic impairment (Child-Pugh A to B), no clinically significant differences in the pharmacokinetics of apalutamide or N-desmethyl apalutamide were observed compared to subjects with normal hepatic function. Drug Interactions Clinical Studies and Model-Informed Approaches Strong CYP2C8 inhibitors : Apalutamide C max decreased by 21% while AUC increased by 68% following co-administration of ERLEADA as a 240 mg single dose with gemfibrozil (a strong CYP2C8 inhibitor). Gemfibrozil is predicted to increase the steady-state apalutamide C max by 32% and AUC by 44%. For the active moieties (sum of unbound apalutamide plus the potency-adjusted unbound N-desmethyl apalutamide), the predicted steady-state C max increased by 19% and AUC by 23%. Strong CYP3A4 inhibitors : Apalutamide C max decreased by 22% while AUC was similar following co-administration of ERLEADA 240 mg as a single dose with itraconazole (a strong CYP3A4 inhibitor). Ketoconazole (a strong CYP3A4 inhibitor) is predicted to increase the single-dose apalutamide AUC by 24% but have no impact on C max . Ketoconazole is predicted to increase the steady-state apalutamide C max by 38% and AUC by 51%. For the active moieties, the predicted steady-state C max increased by 23% and AUC by 28%. Strong CYP3A4 and moderate CYP2C8 inducers : Rifampin (a strong CYP3A4 and moderate CYP2C8 inducer) is predicted to decrease the steady-state apalutamide C max by 25% and AUC by 34%. For the active moieties, the predicted steady-state C max decreased by 15% and AUC by 19%. CYP3A4, CYP2C19, CYP2C9, and CYP2C8 substrates : Co-administration of ERLEADA with single oral doses of sensitive CYP substrates resulted in a 92% decrease in the AUC of midazolam (a CYP3A4 substrate), 85% decrease in the AUC of omeprazole (a CYP2C19 substrate), and 46% decrease in the AUC of S-warfarin (a CYP2C9 substrate). ERLEADA did not cause clinically significant changes in exposure to a CYP2C8 substrate. P-gp, BCRP and OATP1B1 substrates : Co-administration of ERLEADA with single oral doses of transporter substrates resulted in a 30% decrease in the AUC of fexofenadine (a P-gp substrate) and 41% decrease in the AUC of rosuvastatin (a BCRP/OATP1B1 substrate) but had no impact on C max . In Vitro Studies CYP450 Enzymes : Apalutamide and N-desmethyl apalutamide induce and inhibit CYP2B6. Apalutamide does not inhibit or induce CYP1A2 and CYP2D6. Transporter systems : Apalutamide and N-desmethyl apalutamide are substrates for P-gp but not BCRP, OAT1B1, and OATP1B3. Apalutamide and N-desmethyl apalutamide inhibit OCT2, OAT3, and MATEs, but do not inhibit OAT1."],"adverse_reactions":["6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: Cerebrovascular and Ischemic Cardiovascular Events [see Warnings and Precautions (5.1) ] . Fractures [see Warnings and Precautions (5.2) ] . Falls [see Warnings and Precautions (5.3) ] . Seizure [see Warnings and Precautions (5.4) ] . Severe Cutaneous Adverse Reactions (SCARs) [see Warnings and Precautions (5.5) ] . Interstitial Lung Disease (ILD) [see Warnings and Precautions (5.6) ] . The most common adverse reactions (≥10%) are fatigue, arthralgia, rash, decreased appetite, fall, weight decreased, hypertension, hot flush, diarrhea, and fracture. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Products, LP at 1-800-526-7736 (1-800-JANSSEN) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reactions (≥ 10%) that occurred more frequently in the ERLEADA-treated patients (≥ 2% over placebo) from the randomized placebo-controlled clinical trials (TITAN and SPARTAN) were fatigue, arthralgia, rash, decreased appetite, fall, weight decreased, hypertension, hot flush, diarrhea, and fracture. Metastatic Castration-sensitive Prostate Cancer (mCSPC) TITAN, a randomized (1:1), double-blind, placebo-controlled, multi-center clinical study, enrolled patients who had mCSPC. In this study, patients received either ERLEADA at a dose of 240 mg daily or placebo. All patients in the TITAN study received a concomitant gonadotropin-releasing hormone (GnRH) analog or had prior bilateral orchiectomy. The median duration of exposure was 20 months (range: 0 to 34 months) in patients who received ERLEADA and 18 months (range: 0.1 to 34 months) in patients who received placebo. Ten patients (1.9%) who were treated with ERLEADA died from adverse reactions. The reasons for death were ischemic cardiovascular events (n=3), acute kidney injury (n=2), cardio-respiratory arrest (n=1), sudden cardiac death (n=1), respiratory failure (n=1), cerebrovascular accident (n=1), and large intestinal ulcer perforation (n=1). ERLEADA was discontinued due to adverse reactions in 8% of patients, most commonly from rash (2.3%). Adverse reactions leading to dose interruption or reduction of ERLEADA occurred in 23% of patients; the most frequent (>1%) were rash, fatigue, and hypertension. Serious adverse reactions occurred in 20% of ERLEADA-treated patients and 20% in patients receiving placebo. Table 1 shows adverse reactions occurring in ≥10% on the ERLEADA arm in TITAN that occurred with a ≥2% absolute increase in frequency compared to placebo. Table 2 shows laboratory abnormalities that occurred in ≥15% of patients, and more frequently (>5%) in the ERLEADA arm compared to placebo. Table 1: Adverse Reactions in TITAN (mCSPC) ERLEADA N=524 Placebo N=527 System/Organ Class Adverse reaction All Grades % Grade 3–4 % All Grades % Grade 3–4 % Musculoskeletal and connective tissue disorders Arthralgia Per the Common Terminology Criteria for Adverse Reactions (CTCAE), the highest severity for these events is Grade 3 17 0.4 15 0.9 Skin and subcutaneous tissue disorders Rash Includes rash, rash maculo-papular, rash generalized, urticaria, rash pruritic, rash macular, conjunctivitis, erythema multiforme, rash papular, skin exfoliation, genital rash, rash erythematous, stomatitis, drug eruption, lichenoid eruption, mouth ulceration, rash pustular, blister, papule, pemphigoid, skin erosion, dermatitis, and rash vesicular 28 6 9 0.6 Pruritus 11 0.2 4.6 0.2 Vascular disorders Hot flush 23 0 16 0 Hypertension 18 8 16 9 Additional adverse reactions of interest occurring in less than 10% of patients treated with ERLEADA included diarrhea (9% versus 6% on placebo), muscle spasm (3.1% versus 1.9% on placebo), dysgeusia (3.2% versus 0.6% on placebo), hypothyroidism (3.6% versus 0.6% on placebo), and ILD/pneumonitis (1.1% versus 0.4% on placebo). Table 2: Laboratory Abnormalities Occurring in ≥ 15% of ERLEADA-Treated Patients and at a Higher Incidence than Placebo (Between Arm Difference > 5% All Grades) in TITAN (mCSPC) ERLEADA N=524 Placebo N=527 Laboratory Abnormality All Grades % Grade 3–4 % All Grades % Grade 3–4 % Hematology White blood cell decreased 27 0.4 19 0.6 Chemistry Hypertriglyceridemia Does not reflect fasting values 17 2.5 12 2.3 Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) SPARTAN, a randomized (2:1), double-blind, placebo-controlled, multi-center clinical study, enrolled patients who had nmCRPC. In this study, patients received either ERLEADA at a dose of 240 mg daily or a placebo. All patients in the SPARTAN study received a concomitant gonadotropin-releasing hormone (GnRH) analog or had a bilateral orchiectomy. The median duration of exposure was 33 months (range: 0.1 to 75 months) in patients who received ERLEADA and 11 months (range: 0.1 to 37 months) in patients who received placebo. Twenty-four patients (3%) who were treated with ERLEADA died from adverse reactions. The reasons for death with ≥ 2 patients included infection (n=7), myocardial infarction (n=3), cerebrovascular event (n=2), and unknown reason (n=3). ERLEADA was discontinued due to adverse reactions in 11% of patients, most commonly from rash (3.2%). Adverse reactions leading to dose interruption or reduction of ERLEADA occurred in 33% of patients; the most common (>1%) were rash, diarrhea, fatigue, nausea, vomiting, hypertension, and hematuria. Serious adverse reactions occurred in 25% of ERLEADA-treated patients and 23% in patients receiving placebo. The most frequent serious adverse reactions (>2%) were fracture (3.4%) in the ERLEADA arm and urinary retention (3.8%) in the placebo arm. Table 3 shows adverse reactions occurring in ≥10% on the ERLEADA arm in SPARTAN that occurred with a ≥2% absolute increase in frequency compared to placebo. Table 4 shows laboratory abnormalities that occurred in ≥15% of patients, and more frequently (>5%) in the ERLEADA arm compared to placebo. Table 3: Adverse Reactions in SPARTAN (nmCRPC) ERLEADA N=803 Placebo N=398 System/Organ Class Adverse reaction All Grades % Grade 3–4 % All Grades % Grade 3–4 % General disorders and administration site conditions Fatigue Includes fatigue and asthenia , Per the Common Terminology Criteria for Adverse Reactions (CTCAE), the highest severity for these events is Grade 3 39 1.4 28 0.3 Musculoskeletal and connective tissue disorders Arthralgia 16 0 8 0 Skin and subcutaneous tissue disorders Rash Includes rash, rash maculo-papular, rash generalized, urticaria, rash pruritic, rash macular, conjunctivitis, erythema multiforme, rash papular, skin exfoliation, genital rash, rash erythematous, stomatitis, drug eruption, lichenoid eruption, mouth ulceration, rash pustular, blister, papule, pemphigoid, skin erosion, dermatitis, and rash vesicular 25 5.2 6 0.3 Metabolism and nutrition disorders Decreased appetite Includes appetite disorder, decreased appetite, early satiety, and hypophagia 12 0.1 9 0 Peripheral edema Includes peripheral edema, generalized edema, edema, edema genital, penile edema, peripheral swelling, scrotal edema, lymphedema, swelling, and localized edema 11 0 9 0 Injury, poisoning and procedural complications Fall 16 1.7 9 0.8 Fracture Includes rib fracture, lumbar vertebral fracture, spinal compression fracture, spinal fracture, foot fracture, hip fracture, humerus fracture, thoracic vertebral fracture, upper limb fracture, fractured sacrum, hand fracture, pubis fracture, acetabulum fracture, ankle fracture, compression fracture, costal cartilage fracture, facial bones fracture, lower limb fracture, osteoporotic fracture, wrist fracture, avulsion fracture, fibula fracture, fractured coccyx, pelvic fracture, radius fracture, sternal fracture, stress fracture, traumatic fracture, cervical vertebral fracture, femoral neck fracture, and tibia fracture 12 2.7 7 0.8 Investigations Weight decreased 16 1.1 6 0.3 Vascular disorders Hypertension 25 14 20 12 Hot flush 14 0 9 0 Gastrointestinal disorders Diarrhea 20 1.1 15 0.5 Nausea 18 0 16 0 Additional clinically significant adverse reactions occurring in less than 10% of patients treated with ERLEADA included hypothyroidism (8% versus 2% on placebo), pruritus (6% versus 1.5% on placebo), heart failure (2.2% versus 1% on placebo), and ILD/pneumonitis (0.6% versus 0% on placebo). Table 4: Laboratory Abnormalities Occurring in ≥ 15% of ERLEADA-Treated Patients and at a Higher Incidence than Placebo (Between Arm Difference > 5% All Grades) in SPARTAN (nmCRPC) ERLEADA N=803 Placebo N=398 Laboratory Abnormality All Grades % Grade 3–4 % All Grades % Grade 3–4 % Hematology Anemia 70 0.4 64 0.5 Leukopenia 47 0.3 29 0 Lymphopenia 41 1.8 21 1.6 Chemistry Hypercholesterolemia Does not reflect fasting values 76 0.1 46 0 Hyperglycemia 70 2 59 1.0 Hypertriglyceridemia 67 1.6 49 0.8 Hyperkalemia 32 1.9 22 0.5 Rash In the combined data of two randomized, placebo-controlled clinical studies, SPARTAN and TITAN, rash associated with ERLEADA was most commonly described as macular or maculo-papular. Adverse reactions of rash were reported for 26% of patients treated with ERLEADA versus 8% of patients treated with placebo. Grade 3 rashes (defined as covering > 30% body surface area [BSA]) were reported with ERLEADA treatment (6%) versus placebo (0.5%). The onset of rash occurred at a median of 83 days of ERLEADA treatment. Rash resolved in 78% of patients within a median of 78 days from onset of rash. Rash was commonly managed with oral antihistamines, topical corticosteroids, and 19% of patients received systemic corticosteroids. Dose reduction or dose interruption occurred in 14% and 28% of patients, respectively. Of the patients who had dose interruption, 59% experienced recurrence of rash upon reintroduction of ERLEADA. Hypothyroidism In the combined data of two randomized, placebo-controlled clinical studies, SPARTAN and TITAN, hypothyroidism was reported for 8% of patients treated with ERLEADA and 1.5% of patients treated with placebo based on assessments of thyroid-stimulating hormone (TSH) every 4 months. Elevated TSH occurred in 25% of patients treated with ERLEADA and 7% of patients treated with placebo. The median onset was at the first scheduled assessment. There were no Grade 3 or 4 adverse reactions. Thyroid replacement therapy was initiated in 4.9% of patients treated with ERLEADA. Thyroid replacement therapy, when clinically indicated, should be initiated or dose-adjusted [see Drug Interactions (7.2) ] . 6.2 Post-Marketing Experience The following additional adverse reactions have been identified during post-approval use of ERLEADA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure. Respiratory, Thoracic and Mediastinal Disorders: interstitial lung disease/pneumonitis [see Warnings and Precautions (5.6) ] Skin and Subcutaneous Tissue Disorders: Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and lichenoid eruption."],"contraindications":["4 CONTRAINDICATIONS None. ( 4 ) None."],"drug_interactions":["7 DRUG INTERACTIONS Concomitant use with medications that are sensitive substrates of CYP3A4, CYP2C19, CYP2C9, UGT, P-gp, BCRP, or OATP1B1 may result in loss of activity of these medications. ( 7.2 ) 7.1 Effect of Other Drugs on ERLEADA Strong CYP2C8 or CYP3A4 Inhibitors Reduce the ERLEADA dose as recommended for adverse reactions [see Dosage and Administration (2.2) ] . Co-administration of a strong CYP2C8 or CYP3A4 inhibitor is predicted to increase the steady-state exposure of the active moieties (sum of unbound apalutamide plus the potency-adjusted unbound N-desmethyl-apalutamide). 7.2 Effect of ERLEADA on Other Drugs Substrates of CYP3A4, CYP2C9, CYP2C19, P-gp, BCRP, or OATP1B1 Refer to the Prescribing Information for these substrates. Consider alternative agents when possible or evaluate for loss of activity of the substrate if concomitant use cannot be avoided. Apalutamide is a strong inducer of CYP3A4 and CYP2C19, a weak inducer of CYP2C9, and an inducer of P-gp, BCRP, and OATP1B1. Apalutamide decreases exposure of substrates of CYP3A4, CYP2C19, CYP2C9, P-gp, BCRP, or OATP1B1 [see Clinical Pharmacology (12.3) ] , which may decrease the effectiveness of these substrates."],"mechanism_of_action":["12.1 Mechanism of Action Apalutamide is an Androgen Receptor (AR) inhibitor that binds directly to the ligand-binding domain of the AR. Apalutamide inhibits AR nuclear translocation, inhibits DNA binding, and impedes AR-mediated transcription. A major metabolite, N-desmethyl apalutamide, is a less potent inhibitor of AR, and exhibited one-third the activity of apalutamide in an in vitro transcriptional reporter assay. Apalutamide administration caused decreased tumor cell proliferation and increased apoptosis leading to decreased tumor volume in mouse xenograft models of prostate cancer."],"instructions_for_use":["This Instructions for Use has been approved by the U.S. Food and Drug Administration. Revised: 07/2024 INSTRUCTIONS FOR USE ERLEADA ® ( er lee'dah ) (apalutamide) tablets This Instructions for Use contains information on how to prepare and take or give a dose of ERLEADA tablets if you cannot swallow ERLEADA tablets whole or if you have a feeding tube. Read this Instructions for Use before you prepare and take or give the first dose of ERLEADA, and each time you get a refill. Ask your healthcare provider or pharmacist if you have any questions. Important information you need to know before preparing a dose of ERLEADA: ERLEADA comes in 2 different strengths, 60 mg tablets and 240 mg tablets. Please find the instructions below that refer to your prescribed ERLEADA strength for how to prepare and take or give ERLEADA tablets. Preparing and taking ERLEADA if you cannot swallow tablets whole: Preparing and taking ERLEADA 60 mg tablets by placing the tablets in non-carbonated water then mixing with orange juice, applesauce, or more non-carbonated water: Step 1. Place your entire prescribed dose of 60 mg tablets in a cup. Do not crush or split the tablets. Step 2. Add about 4 teaspoons (20 mL) of non-carbonated water to make sure that the tablets are completely covered in water. Step 3. Wait 2 minutes until the tablets are broken up and spread out, then stir the mixture. Step 4. Add 2 tablespoons (30 mL) of orange juice, applesauce, or non-carbonated water to the cup and stir the mixture. Step 5. Swallow the mixture right away. Step 6. Rinse the cup with enough non-carbonated water to make sure that you take your full dose of ERLEADA and drink it right away. Do not store ERLEADA that is mixed with non-carbonated water, orange juice, or applesauce for later use. Preparing and taking ERLEADA 240 mg tablet by placing the tablet in non-carbonated water then mixing with orange juice, applesauce, or more non-carbonated water: Step 1. Place the whole 240 mg tablet in a cup. Do not crush or split the tablet. Step 2. Add about 2 teaspoons (10 mL) of non-carbonated water to make sure that the tablet is completely covered in water. Step 3. Wait 2 minutes until the tablet is broken up and spread out, then stir the mixture. Step 4. Add 2 tablespoons (30 mL) of orange juice, applesauce, or non-carbonated water to the cup and stir the mixture. Step 5. Swallow the mixture right away. Step 6. Rinse the cup with enough non-carbonated water to make sure that you take your full dose of ERLEADA and drink it right away. Do not store ERLEADA that is mixed with non-carbonated water, orange juice, or applesauce for later use. Preparing and giving ERLEADA through a feeding tube: Preparing and giving ERLEADA 60 mg tablets through a feeding tube 8 French or larger: Step 1. Remove the plunger out of the syringe (use at least a 50 mL syringe). Step 2. Add your entire prescribed dose of 60 mg tablets into the syringe body (barrel) and place the plunger back in the syringe. Do not crush or split the tablets. Step 3. Withdraw 20 mL of non-carbonated water into the syringe. Step 4. Wait 10 minutes and then shake the syringe very well (vigorously) to break the tablets apart completely. Step 5. Attach the syringe to the feeding tube and give the mixture right away. Step 6. Withdraw non-carbonated water into the same syringe and flush through the feeding tube. Repeat Step 6 until no pieces of tablets are left in the syringe or feeding tube. Preparing and giving ERLEADA 240 mg tablet through a feeding tube 8 French or larger: Step 1. Remove the plunger out of the syringe (use at least a 20 mL syringe). Step 2. Add one 240 mg tablet into the syringe body (barrel) and place the plunger back in the syringe. Do not crush or split the tablet. Step 3. Withdraw 10 mL of non-carbonated water into the syringe. Step 4. Wait 10 minutes and then shake the syringe very well (vigorously) to break the tablet apart completely. Step 5. Attach the syringe to the feeding tube and give the mixture right away. Step 6. Withdraw non-carbonated water into the same syringe and flush through the feeding tube. Repeat Step 6 until no pieces of tablet are left in the syringe or feeding tube. How should I store ERLEADA? Store ERLEADA at room temperature between 68 °F to 77 °F (20 °C to 25 °C). ERLEADA comes in a child-resistant bottle. Store ERLEADA in the original package to protect from light and moisture. The bottle of ERLEADA contains a desiccant packet to help keep your medicine dry (protect it from moisture). Do not throw away (discard) the desiccant. Keep ERLEADA and all medicines out of the reach of children. Manufactured for: Janssen Products, LP, Horsham, PA 19044, USA For patent information: www.janssenpatents.com © 2019, 2023 Janssen Pharmaceutical Companies For more information, call Janssen Products, LP at 1-800-526-7736 (1-800-JANSSEN) or go to www.erleada.com."],"recent_major_changes":["Dosage and Administration, Recommended Dosage ( 2.1 , 2.2 , 2.3 ) 03/2026"],"storage_and_handling":["Storage and Handling Store at 20 °C to 25 °C (68 °F to 77 °F); excursions permitted to 15 °C to 30 °C (59 °F to 86 °F) [see USP Controlled Room Temperature] . Store in original package to protect from light and moisture. Do not discard desiccant."],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Apalutamide is an Androgen Receptor (AR) inhibitor that binds directly to the ligand-binding domain of the AR. Apalutamide inhibits AR nuclear translocation, inhibits DNA binding, and impedes AR-mediated transcription. A major metabolite, N-desmethyl apalutamide, is a less potent inhibitor of AR, and exhibited one-third the activity of apalutamide in an in vitro transcriptional reporter assay. Apalutamide administration caused decreased tumor cell proliferation and increased apoptosis leading to decreased tumor volume in mouse xenograft models of prostate cancer. 12.2 Pharmacodynamics ERLEADA 240 mg daily in addition to ADT in patients with mCSPC (TITAN) reduced PSA to undetectable levels (<0.2 ng/mL) in 68% of patients compared to 32% of patients taking ADT alone. ERLEADA 240 mg daily in addition to ADT in patients with nmCRPC (SPARTAN) reduced PSA to undetectable levels (<0.2 ng/mL) in 38% of patients compared to no patients (0%) taking ADT alone. The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of apalutamide have not been fully characterized. Cardiac Electrophysiology At the approved recommended dosage, the maximum mean QTcF change from baseline was 12.4 ms (2-sided 90% upper CI: 16.0 ms). An exposure-QT analysis suggested a concentration-dependent increase in QTcF for apalutamide and its active metabolite. 12.3 Pharmacokinetics Apalutamide and N-desmethyl apalutamide pharmacokinetic parameters were observed at steady state following the approved recommended dosage for ERLEADA and are presented as the mean [standard deviation (SD)] unless otherwise specified. Apalutamide maximum concentration (C max ) is 6 mcg/mL (1.7) and total systemic exposure (AUC) is 100 mcg∙h/mL (32). Apalutamide C max and AUC increases in a dose proportional manner following repeated once-daily dosing of 30 to 480 mg (0.125 to 2 times the recommended dosage). Apalutamide steady-state is achieved after 4 weeks and the mean accumulation ratio is approximately 5-fold. The major active metabolite N-desmethyl apalutamide C max is 5.9 mcg/mL (1) and AUC is 124 mcg∙h/mL (23). Mean AUC metabolite/parent drug ratio for N-desmethyl apalutamide following repeat-dose administration is 1.3. Based on systemic exposure, relative potency, and pharmacokinetic properties, N-desmethyl apalutamide likely contributes to the clinical activity of apalutamide. Absorption Apalutamide absolute oral bioavailability is approximately 100%. Apalutamide median (min, max) time to maximum plasma concentration (t max ) is 2 hours (1, 5 hours). No clinically significant changes in C max and AUC were observed following oral administration of four 60 mg tablets dispersed in applesauce compared to administration of four intact 60 mg tablets under fasting condition. Effect of Food No clinically significant differences in apalutamide C max and AUC were observed following administration of a high-fat meal (approximately 500 to 600 fat calories, 250 carbohydrate calories, and 150 protein calories). Median time to reach t max was delayed approximately 2 hours with food. Distribution Apalutamide apparent volume of distribution is approximately 276 L. Apalutamide is 96% and N-desmethyl apalutamide is 95% bound to plasma proteins with no concentration dependency. Elimination Apalutamide half-life is approximately 3 days. The CL/F of apalutamide is 1.3 L/h after single dosing and increases to 2.0 L/h at steady-state after once-daily dosing likely due to CYP3A4 auto-induction. Metabolism Apalutamide is primarily metabolized by CYP2C8 and CYP3A4 to form active metabolite, N-desmethyl apalutamide. The contribution of CYP2C8 and CYP3A4 in the metabolism of apalutamide is estimated to be 58% and 13% following single dose but changes to 40% and 37%, respectively at steady-state. Apalutamide represented 45% and N-desmethyl apalutamide represented 44% of the total AUC following a single oral administration of radiolabeled apalutamide 240 mg. Excretion Up to 70 days following a single oral administration of radiolabeled apalutamide, 65% of the dose was recovered in urine (1.2% of dose as unchanged apalutamide and 2.7% as N-desmethyl apalutamide) and 24% was recovered in feces (1.5% of dose as unchanged apalutamide and 2% as N-desmethyl apalutamide). Specific Populations No clinically significant differences in the pharmacokinetics of apalutamide or N-desmethyl apalutamide were observed based on age (18-94 years), race (Black, non-Japanese Asian, Japanese), or eGFR 30-89 mL/min/1.73 m 2 (estimated by MDRD equation). The effect of eGFR ≤29 mL/min/1.73 m 2 on apalutamide pharmacokinetics is unknown. Patients with Hepatic Impairment In subjects with severe hepatic impairment (Child-Pugh C), AUC for the active moieties (sum of unbound apalutamide plus the potency-adjusted unbound N-desmethyl apalutamide) increased 2.1-fold compared to subjects with normal hepatic function. In subjects with mild to moderate hepatic impairment (Child-Pugh A to B), no clinically significant differences in the pharmacokinetics of apalutamide or N-desmethyl apalutamide were observed compared to subjects with normal hepatic function. Drug Interactions Clinical Studies and Model-Informed Approaches Strong CYP2C8 inhibitors : Apalutamide C max decreased by 21% while AUC increased by 68% following co-administration of ERLEADA as a 240 mg single dose with gemfibrozil (a strong CYP2C8 inhibitor). Gemfibrozil is predicted to increase the steady-state apalutamide C max by 32% and AUC by 44%. For the active moieties (sum of unbound apalutamide plus the potency-adjusted unbound N-desmethyl apalutamide), the predicted steady-state C max increased by 19% and AUC by 23%. Strong CYP3A4 inhibitors : Apalutamide C max decreased by 22% while AUC was similar following co-administration of ERLEADA 240 mg as a single dose with itraconazole (a strong CYP3A4 inhibitor). Ketoconazole (a strong CYP3A4 inhibitor) is predicted to increase the single-dose apalutamide AUC by 24% but have no impact on C max . Ketoconazole is predicted to increase the steady-state apalutamide C max by 38% and AUC by 51%. For the active moieties, the predicted steady-state C max increased by 23% and AUC by 28%. Strong CYP3A4 and moderate CYP2C8 inducers : Rifampin (a strong CYP3A4 and moderate CYP2C8 inducer) is predicted to decrease the steady-state apalutamide C max by 25% and AUC by 34%. For the active moieties, the predicted steady-state C max decreased by 15% and AUC by 19%. CYP3A4, CYP2C19, CYP2C9, and CYP2C8 substrates : Co-administration of ERLEADA with single oral doses of sensitive CYP substrates resulted in a 92% decrease in the AUC of midazolam (a CYP3A4 substrate), 85% decrease in the AUC of omeprazole (a CYP2C19 substrate), and 46% decrease in the AUC of S-warfarin (a CYP2C9 substrate). ERLEADA did not cause clinically significant changes in exposure to a CYP2C8 substrate. P-gp, BCRP and OATP1B1 substrates : Co-administration of ERLEADA with single oral doses of transporter substrates resulted in a 30% decrease in the AUC of fexofenadine (a P-gp substrate) and 41% decrease in the AUC of rosuvastatin (a BCRP/OATP1B1 substrate) but had no impact on C max . In Vitro Studies CYP450 Enzymes : Apalutamide and N-desmethyl apalutamide induce and inhibit CYP2B6. Apalutamide does not inhibit or induce CYP1A2 and CYP2D6. Transporter systems : Apalutamide and N-desmethyl apalutamide are substrates for P-gp but not BCRP, OAT1B1, and OATP1B3. Apalutamide and N-desmethyl apalutamide inhibit OCT2, OAT3, and MATEs, but do not inhibit OAT1."],"indications_and_usage":["1 INDICATIONS AND USAGE ERLEADA is indicated for the treatment of patients with Metastatic castration-sensitive prostate cancer (mCSPC) Non-metastatic castration-resistant prostate cancer (nmCRPC) ERLEADA is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer. ( 1 ) non-metastatic castration-resistant prostate cancer. ( 1 )"],"warnings_and_cautions":["5 WARNINGS AND PRECAUTIONS Cerebrovascular and ischemic cardiovascular events occurred in patients receiving ERLEADA. Monitor for signs and symptoms of cerebrovascular disorders and ischemic heart disease. Optimize management of cardiovascular risk factors. ( 5.1 ). Fractures occurred in patients receiving ERLEADA. Evaluate patients for fracture risk and treat patients with bone-targeted agents according to established guidelines. ( 5.2 ) Falls occurred in patients receiving ERLEADA with increased incidence in the elderly. Evaluate patients for fall risk. ( 5.3 ) Seizure occurred in 0.4% of patients receiving ERLEADA. Permanently discontinue ERLEADA in patients who develop a seizure during treatment. ( 5.4 ) Severe Cutaneous Adverse Reactions (SCARs), including Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS), occurred in patients treated with ERLEADA. Interrupt ERLEADA if signs or symptoms of SCARs develop. Permanently discontinue if SCARs are confirmed. ( 5.5 ) Interstitial Lung Disease (ILD)/pneumonitis occurred in patients treated with ERLEADA. Withhold ERLEADA for suspected ILD/pneumonitis. Permanently discontinue ERLEADA in patients with severe ILD/pneumonitis or if no other potential causes of ILD/pneumonitis are identified. ( 2.2 , 5.6 ) Embryo-Fetal Toxicity: ERLEADA can cause fetal harm. Advise males with female partners of reproductive potential to use effective contraception. ( 5.7 , 8.1 , 8.3 ) 5.1 Cerebrovascular and Ischemic Cardiovascular Events Cerebrovascular and ischemic cardiovascular events, including events leading to death, occurred in patients receiving ERLEADA. Monitor for signs and symptoms of ischemic heart disease and cerebrovascular disorders. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Consider discontinuation of ERLEADA for Grade 3 and 4 events. In a randomized study (SPARTAN) of patients with nmCRPC, ischemic cardiovascular events occurred in 3.7% of patients treated with ERLEADA and 2% of patients treated with placebo. In a randomized study (TITAN) in patients with mCSPC, ischemic cardiovascular events occurred in 4.4% of patients treated with ERLEADA and 1.5% of patients treated with placebo. Across the SPARTAN and TITAN studies, 4 patients (0.3%) treated with ERLEADA, and 2 patients (0.2%) treated with placebo died from an ischemic cardiovascular event. In the SPARTAN study, cerebrovascular events occurred in 2.5% of patients treated with ERLEADA and 1% of patients treated with placebo [see Adverse Reactions (6.1) ] . In the TITAN study, cerebrovascular events occurred in 1.9% of patients treated with ERLEADA and 2.1% of patients treated with placebo. Across the SPARTAN and TITAN studies, 3 patients (0.2%) treated with ERLEADA, and 2 patients (0.2%) treated with placebo died from a cerebrovascular event. Patients with history of unstable angina, myocardial infarction, congestive heart failure, stroke, or transient ischemic attack within six months of randomization were excluded from the SPARTAN and TITAN studies. 5.2 Fractures Fractures occurred in patients receiving ERLEADA. Evaluate patients for fracture risk. Monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone-targeted agents. In a randomized study (SPARTAN) of patients with non-metastatic castration-resistant prostate cancer, fractures occurred in 12% of patients treated with ERLEADA and in 7% of patients treated with placebo. Grade 3–4 fractures occurred in 2.7% of patients treated with ERLEADA and in 0.8% of patients treated with placebo. The median time to onset of fracture was 314 days (range: 20 to 953 days) for patients treated with ERLEADA. Routine bone density assessment and treatment of osteoporosis with bone-targeted agents were not performed in the SPARTAN study. In a randomized study (TITAN) of patients with metastatic castration-sensitive prostate cancer, fractures occurred in 9% of patients treated with ERLEADA and in 6% of patients treated with placebo. Grade 3–4 fractures were similar in both arms at 1.5%. The median time to onset of fracture was 56 days (range: 2 to 111 days) for patients treated with ERLEADA. Routine bone density assessment and treatment of osteoporosis with bone-targeted agents were not performed in the TITAN study. 5.3 Falls Falls occurred in patients receiving ERLEADA with increased frequency in the elderly [see Use in Specific Populations (8.5) ] . Evaluate patients for fall risk. In a randomized study (SPARTAN), falls occurred in 16% of patients treated with ERLEADA compared to 9% of patients treated with placebo. Falls were not associated with loss of consciousness or seizure. 5.4 Seizure Seizure occurred in patients receiving ERLEADA. Permanently discontinue ERLEADA in patients who develop a seizure during treatment. It is unknown whether anti-epileptic medications will prevent seizures with ERLEADA. Advise patients of the risk of developing a seizure while receiving ERLEADA and of engaging in any activity where sudden loss of consciousness could cause harm to themselves or others. In two randomized studies (SPARTAN and TITAN), five patients (0.4%) treated with ERLEADA and one patient treated with placebo (0.1%) experienced a seizure. Seizure occurred from 159 to 650 days after initiation of ERLEADA. Patients with a history of seizure, predisposing factors for seizure, or receiving drugs known to decrease the seizure threshold or to induce seizure were excluded. There is no clinical experience in re-administering ERLEADA to patients who experienced a seizure. 5.5 Severe Cutaneous Adverse Reactions Fatal and life-threatening cases of severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), occurred in patients receiving ERLEADA [see Adverse Reactions (6.2) ] . Monitor patients for the development of SCARs. Advise patients of the signs and symptoms of SCARs (e.g., a prodrome of fever, flu-like symptoms, mucosal lesions, progressive skin rash, or lymphadenopathy). If a SCAR is suspected, interrupt ERLEADA until the etiology of the reaction has been determined. Consultation with a dermatologist is recommended. If a SCAR is confirmed, or for other grade 4 skin reactions, permanently discontinue ERLEADA [see Dosage and Administration (2.2) and Adverse Reactions (6.1) ] . 5.6 Interstitial Lung Disease (ILD)/Pneumonitis Fatal and life-threatening interstitial lung disease (ILD) or pneumonitis can occur in patients treated with ERLEADA. Post-marketing cases of ILD/pneumonitis, including fatal cases, occurred in patients treated with ERLEADA. Across clinical trials (TITAN and SPARTAN, n=1327), 0.8% of patients treated with ERLEADA experienced ILD/pneumonitis, including 0.2% who experienced Grade 3 events [see Adverse Reactions (6.1 , 6.2) ]. Monitor patients for new or worsening symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold ERLEADA if ILD/pneumonitis is suspected. Permanently discontinue ERLEADA in patients with severe ILD/pneumonitis or if no other potential causes of ILD/pneumonitis are identified [see Dosage and Administration (2.2) ] . 5.7 Embryo-Fetal Toxicity The safety and efficacy of ERLEADA have not been established in females. Based on findings from animals and its mechanism of action, ERLEADA can cause fetal harm and loss of pregnancy when administered to a pregnant female. In an animal reproduction study, oral administration of apalutamide to pregnant rats during and after organogenesis resulted in fetal abnormalities and embryo-fetal lethality at maternal exposures ≥ 2 times the human clinical exposure (AUC) at the recommended dose. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of ERLEADA [see Use in Specific Populations (8.1 , 8.3) and Clinical Pharmacology (12.1) ] ."],"clinical_studies_table":["
Table 5: Efficacy Results from the TITAN Study
EndpointERLEADA (N=525)Placebo (N=527)
Primary Overall SurvivalInterim analysis is based on 50% of the number of events planned for the final analysis. Allocated alpha = 0.01.
Deaths (%)83 (16%)117 (22%)
Median, months (95% CI)NE=Not EstimableNE (NE, NE)NE (NE, NE)
Hazard Ratio (95% CI)Hazard ratio is from stratified proportional hazards model. Hazard ratio <1 favors ERLEADA.0.67 (0.51, 0.89)
p-valuep-value is from the log-rank test stratified by Gleason score at diagnosis (≤7 vs. >7), Region (NA/EU vs. Other Countries) and Prior docetaxel use (Yes vs. No).0.0053
Updated Overall Survival
Deaths (%)170 (32%)235 (45%)
Median, months (95% CI)NE (NE, NE)52 (42, NE)
Hazard Ratio (95% CI)0.65 (0.53, 0.79)
Radiographic Progression-free Survival
Disease progression or death (%)134 (26%)231 (44%)
Median, months (95% CI)NE (NE, NE)22.1 (18, 33)
Hazard Ratio (95% CI)0.48 (0.39, 0.60)
p-value<0.0001
","
Figure 1: Kaplan-Meier Plot of Updated Overall Survival (OS); Intent-to-treat mCSPC Population (TITAN)
","
Figure 2: Kaplan-Meier Plot of Radiographic Progression-Free Survival (rPFS); Intent-to-treat mCSPC Population (TITAN)
","
Table 6: Efficacy Results from the SPARTAN Study
EndpointERLEADA (N=806)Placebo (N=401)
Metastasis Free SurvivalAll analyses stratified by PSA doubling time, bone-sparing agent use, and locoregional disease status.,Confirmed responses assessed by BICR.,Locoregional-only progression is observed in 2.4% of patients overall.
Number of Events (%)184 (23%)194 (48%)
Median, months (95% CI)NE=Not Estimable40.5 (NE, NE)16.2 (15, 18)
Hazard Ratio (95% CI)0.28 (0.23, 0.35)
p-value<0.0001
Time to Metastasis,
Number of Events (%)175 (22%)191 (48%)
Median, months (95% CI)40.5 (NE, NE)16.6 (15, 18)
Hazard Ratio (95% CI)0.27 (0.22, 0.34)
p-value<0.0001
Progression-Free Survival,
Number of Events (%)200 (25%)204 (51%)
Median, months (95% CI)40.5 (NE, NE)14.7 (14, 18)
Hazard Ratio (95% CI)0.29 (0.24, 0.36)
p-value<0.0001
Overall Survival
Number of Events (%)274 (34%)154 (38%)
Median, months (95% CI)73.9 (61, NE)59.9 (53, NE)
Hazard Ratio (95% CI)0.78 (0.64, 0.96)
p-value0.0161
","
Figure 3: Kaplan-Meier Metastasis-Free Survival (MFS) Curve in SPARTAN (nmCRPC)
","
Figure 4: Kaplan-Meier Overall Survival (OS) Curve in SPARTAN (nmCRPC)
"],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility In a 2-year carcinogenicity study in male rats, apalutamide was administered by oral gavage at doses of 5, 15 and 50 mg/kg/day. Apalutamide increased the incidence of Leydig interstitial cell adenoma in the testes at doses ≥ 5 mg/kg/day (0.2 times the human exposure based on AUC). The findings in the testes are considered to be related to the pharmacological activity of apalutamide. Rats are regarded as more sensitive than humans to developing interstitial cell tumors in the testes. Oral administration of apalutamide to male rasH2 transgenic mice for 6 months did not result in increased incidence of neoplasms at doses up to 30 mg/kg/day. Apalutamide did not induce mutations in the bacterial reverse mutation (Ames) assay and was not genotoxic in either in vitro chromosome aberration assay or the in vivo rat bone marrow micronucleus assay or the in vivo rat Comet assay. In repeat-dose toxicity studies in male rats (up to 26 weeks) and dogs (up to 39 weeks), atrophy of the prostate gland and seminal vesicles, aspermia/hypospermia, tubular degeneration and/or hyperplasia or hypertrophy of the interstitial cells in the reproductive system were observed at ≥ 25 mg/kg/day in rats (1.4 times the human exposure based on AUC) and ≥ 2.5 mg/kg/day in dogs (0.9 times the human exposure based on AUC). In a fertility study in male rats, a decrease in sperm concentration and motility, increased abnormal sperm morphology, lower copulation and fertility rates (upon pairing with untreated females) along with reduced weights of the secondary sex glands and epididymis were observed following 4 weeks of dosing at ≥ 25 mg/kg/day (0.8 times the human exposure based on AUC). A reduced number of live fetuses due to increased pre- and/or post-implantation loss was observed following 4 weeks of 150 mg/kg/day administration (5.7 times the human exposure based on AUC). Effects on male rats were reversible after 8 weeks from the last apalutamide administration."],"adverse_reactions_table":["
Table 1: Adverse Reactions in TITAN (mCSPC)
ERLEADA N=524Placebo N=527
System/Organ Class Adverse reactionAll Grades %Grade 3–4 %All Grades %Grade 3–4 %
Musculoskeletal and connective tissue disorders
ArthralgiaPer the Common Terminology Criteria for Adverse Reactions (CTCAE), the highest severity for these events is Grade 3170.4150.9
Skin and subcutaneous tissue disorders
RashIncludes rash, rash maculo-papular, rash generalized, urticaria, rash pruritic, rash macular, conjunctivitis, erythema multiforme, rash papular, skin exfoliation, genital rash, rash erythematous, stomatitis, drug eruption, lichenoid eruption, mouth ulceration, rash pustular, blister, papule, pemphigoid, skin erosion, dermatitis, and rash vesicular28690.6
Pruritus110.24.60.2
Vascular disorders
Hot flush230160
Hypertension188169
","
Table 2: Laboratory Abnormalities Occurring in ≥ 15% of ERLEADA-Treated Patients and at a Higher Incidence than Placebo (Between Arm Difference > 5% All Grades) in TITAN (mCSPC)
ERLEADA N=524Placebo N=527
Laboratory AbnormalityAll Grades %Grade 3–4 %All Grades %Grade 3–4 %
Hematology
White blood cell decreased270.4190.6
Chemistry
HypertriglyceridemiaDoes not reflect fasting values172.5122.3
","
Table 3: Adverse Reactions in SPARTAN (nmCRPC)
ERLEADA N=803Placebo N=398
System/Organ Class Adverse reactionAll Grades %Grade 3–4 %All Grades %Grade 3–4 %
General disorders and administration site conditions
FatigueIncludes fatigue and asthenia,Per the Common Terminology Criteria for Adverse Reactions (CTCAE), the highest severity for these events is Grade 3391.4280.3
Musculoskeletal and connective tissue disorders
Arthralgia16080
Skin and subcutaneous tissue disorders
RashIncludes rash, rash maculo-papular, rash generalized, urticaria, rash pruritic, rash macular, conjunctivitis, erythema multiforme, rash papular, skin exfoliation, genital rash, rash erythematous, stomatitis, drug eruption, lichenoid eruption, mouth ulceration, rash pustular, blister, papule, pemphigoid, skin erosion, dermatitis, and rash vesicular255.260.3
Metabolism and nutrition disorders
Decreased appetiteIncludes appetite disorder, decreased appetite, early satiety, and hypophagia120.190
Peripheral edemaIncludes peripheral edema, generalized edema, edema, edema genital, penile edema, peripheral swelling, scrotal edema, lymphedema, swelling, and localized edema11090
Injury, poisoning and procedural complications
Fall161.790.8
FractureIncludes rib fracture, lumbar vertebral fracture, spinal compression fracture, spinal fracture, foot fracture, hip fracture, humerus fracture, thoracic vertebral fracture, upper limb fracture, fractured sacrum, hand fracture, pubis fracture, acetabulum fracture, ankle fracture, compression fracture, costal cartilage fracture, facial bones fracture, lower limb fracture, osteoporotic fracture, wrist fracture, avulsion fracture, fibula fracture, fractured coccyx, pelvic fracture, radius fracture, sternal fracture, stress fracture, traumatic fracture, cervical vertebral fracture, femoral neck fracture, and tibia fracture122.770.8
Investigations
Weight decreased161.160.3
Vascular disorders
Hypertension25142012
Hot flush14090
Gastrointestinal disorders
Diarrhea201.1150.5
Nausea180160
","
Table 4: Laboratory Abnormalities Occurring in ≥ 15% of ERLEADA-Treated Patients and at a Higher Incidence than Placebo (Between Arm Difference > 5% All Grades) in SPARTAN (nmCRPC)
ERLEADA N=803Placebo N=398
Laboratory AbnormalityAll Grades %Grade 3–4 %All Grades %Grade 3–4 %
Hematology
Anemia700.4640.5
Leukopenia470.3290
Lymphopenia411.8211.6
Chemistry
HypercholesterolemiaDoes not reflect fasting values760.1460
Hyperglycemia702591.0
Hypertriglyceridemia671.6490.8
Hyperkalemia321.9220.5
"],"information_for_patients":["17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Cerebrovascular and Ischemic Cardiovascular Events Inform patients that ERLEADA has been associated with cerebrovascular and ischemic cardiovascular events. Advise patients to seek immediate medical attention if any symptoms suggestive of a cardiovascular or a cerebrovascular event occur [see Warnings and Precautions (5.1) ] . Falls and Fractures Inform patients that ERLEADA is associated with an increased incidence of falls and fractures [see Warnings and Precautions (5.2 , 5.3) ] . Seizures Inform patients that ERLEADA has been associated with an increased risk of seizure. Discuss conditions that may predispose to seizures and medications that may lower the seizure threshold. Advise patients of the risk of engaging in any activity where sudden loss of consciousness could cause serious harm to themselves or others. Inform patients to contact their healthcare provider right away if they experience a seizure [see Warnings and Precautions (5.4) ] . Severe Cutaneous Adverse Reactions (SCARs) Inform patients that ERLEADA has been associated with SCARs (including SJS/TEN and DRESS), which can be fatal or life-threatening. Advise patients to stop taking ERLEADA and contact their healthcare provider or seek medical attention right away if they experience signs or symptoms of SCARs [see Warnings and Precautions (5.5) ] . Interstitial Lung Disease (ILD)/Pneumonitis Inform patients of the risks of fatal or life-threatening ILD/pneumonitis. Advise patients to stop taking ERLEADA and contact their healthcare provider or seek medical attention immediately if they develop new or worsening respiratory symptoms [see Warnings and Precautions (5.6) ] . Rash Inform patients that ERLEADA is associated with rashes and to inform their healthcare provider if they develop a rash [see Adverse Reactions (6.1 , 6.2) ] . Dosage and Administration Inform patients receiving concomitant gonadotropin-releasing hormone (GnRH) analog therapy that they need to maintain this treatment during the course of treatment with ERLEADA. Instruct patients to take their dose at the same time each day (once daily). ERLEADA can be taken with or without food. Each tablet should be swallowed whole. Do not crush or split tablets [see Dosage and Administration (2.1) ] . Instruct patients who cannot swallow tablets whole to follow the instructions for the prescribed strength of ERLEADA tablets for alternate methods of administration, including administration through a feeding tube [see Dosage and Administration (2.4) ] . Inform patients that in the event of a missed daily dose of ERLEADA, they should take their normal dose as soon as possible on the same day with a return to the normal schedule on the following day. The patient should not take extra tablets to make up the missed dose [see Dosage and Administration (2.1) ] . Embryo-Fetal Toxicity Inform patients that ERLEADA can be harmful to a developing fetus. Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of ERLEADA. Advise male patients to use a condom if having sex with a pregnant woman [see Warnings and Precautions (5.7) ] . Infertility Advise male patients that ERLEADA may impair fertility and not to donate sperm during therapy and for 3 months following the last dose of ERLEADA [see Use in Specific Populations (8.3) ] ."],"spl_unclassified_section":["Manufactured for: Janssen Products, LP Horsham, PA 19044, USA For patent information: www.janssenpatents.com © 2019, 2023 Janssen Pharmaceutical Companies"],"dosage_and_administration":["2 DOSAGE AND ADMINISTRATION ERLEADA 240 mg orally once daily. Swallow tablets whole. ERLEADA can be taken with or without food. ( 2.1 ) The recommended ERLEADA dosage in patients with severe hepatic impairment is 120 mg orally once daily. ( 2.3 ) Patients should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. ( 2.1 ) 2.1 Recommended Dosage The recommended dosage of ERLEADA is 240 mg orally once daily. ERLEADA can be taken with or without food [see Clinical Pharmacology (12.3) ] . Swallow the tablet(s) whole. Do not crush or split tablet(s). Patients should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had a bilateral orchiectomy. 2.2 Dosage Modifications for Adverse Reactions If Grade 3 or 4 adverse reactions, or other intolerable adverse reactions occur, withhold ERLEADA. Consider permanent discontinuation of ERLEADA for Grade 3 or 4 cerebrovascular and ischemic cardiovascular events [see Warnings and Precautions (5.1) ] . Permanently discontinue ERLEADA for severe ILD/pneumonitis or if no other potential causes of ILD/pneumonitis are identified, or confirmed SCARs, or for other Grade 4 skin reactions [see Warnings and Precautions (5.5 , 5.6) and Adverse Reactions (6.1) ] . For other adverse reactions, including those that may be related to increased exposure to ERLEADA due to drug interactions [see Drug Interactions (7.1) ] , resume ERLEADA at the same dose or at a reduced dose (180 mg or 120 mg) when symptoms improve to less than or equal to Grade 1 or original grade, if warranted. If the ERLEADA dose was reduced for an adverse reaction while receiving a drug that increases exposure to ERLEADA, consider resuming the previously tolerated dose after the drug has been discontinued for at least 3 half-lives. 2.3 Recommended Dosage in Patients with Severe Hepatic Impairment The recommended dosage of ERLEADA for patients with severe hepatic impairment (Child-Pugh Class C) is 120 mg orally once daily [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ] . 2.4 Alternate Methods of Administration Disperse Tablet(s) in Water and Administer with Orange Juice, Applesauce, or Additional Water For patients who cannot swallow tablets whole, the recommended dose of ERLEADA tablet(s) can be dispersed in non-carbonated water and then administered with either orange juice, applesauce, or additional water as follows: Place the entire prescribed dose of ERLEADA tablet(s) in a cup. Do not crush or split the tablet(s). For one 240 mg tablet: Add about 2 teaspoons (10 mL) of non-carbonated water to make sure that the tablet is completely immersed in water. For 60 mg tablets (prescribed dose of 240 mg, 180 mg, or 120 mg): Add about 4 teaspoons (20 mL) of non-carbonated water to make sure that the tablets are completely immersed in water. Wait 2 minutes until the tablet(s) are broken up and spread out, then stir the mixture. Add 2 tablespoons (30 mL) of either orange juice, applesauce, or additional water and stir the mixture. Swallow the mixture immediately. Rinse the cup with enough water to make sure the whole dose is taken and drink it immediately. Do not store ERLEADA that is mixed with non-carbonated water, orange juice, or applesauce for later use. Administer Tablet(s) Through a Feeding Tube ERLEADA tablet(s) can be administered through a feeding tube 8 French or greater as follows: For one 240 mg tablet: Place the tablet in the barrel of the syringe (use at least a 20 mL syringe) and draw up 10 mL of non-carbonated water into the syringe. For 60 mg tablets (prescribed dose of 240 mg, 180 mg, or 120 mg): Place the entire prescribed dose of ERLEADA tablets in the barrel of the syringe (use at least a 50 mL syringe) and draw up 20 mL of non-carbonated water into the syringe. Wait 10 minutes and then shake vigorously to disperse contents completely. Administer immediately through the feeding tube. Refill the syringe with non-carbonated water and administer. Repeat until no tablet residue is left in the syringe or feeding tube."],"spl_product_data_elements":["ERLEADA Apalutamide CROSCARMELLOSE SODIUM HYPROMELLOSE ACETATE SUCCINATE 16070722 (3 MPA.S) MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE FERROSOFERRIC OXIDE FERRIC OXIDE YELLOW POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED TALC TITANIUM DIOXIDE APALUTAMIDE APALUTAMIDE SILICON DIOXIDE slightly yellowish to greyish green Oblong AR;60 ERLEADA Apalutamide SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSE ACETATE SUCCINATE 16070722 (3 MPA.S) MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE GLYCERYL MONOCAPRYLOCAPRATE FERROSOFERRIC OXIDE POLYVINYL ALCOHOL GRAFT POLYETHYLENE GLYCOL COPOLYMER (3:1; 45000 MW) POLYVINYL ALCOHOL, UNSPECIFIED TALC TITANIUM DIOXIDE APALUTAMIDE APALUTAMIDE Bluish grey to grey E240"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS Tablets: 240 mg: bluish grey to grey, oval, film-coated and debossed with \"E240\" on one side. 60 mg: slightly yellowish to greyish green, oblong, film-coated and debossed with \"AR 60\" on one side. Tablets: 240 mg ( 3 ) Tablets: 60 mg ( 3 )"],"instructions_for_use_table":["
This Instructions for Use has been approved by the U.S. Food and Drug Administration.Revised: 07/2024
INSTRUCTIONS FOR USE ERLEADA® (er lee'dah) (apalutamide) tablets
This Instructions for Use contains information on how to prepare and take or give a dose of ERLEADA tablets if you cannot swallow ERLEADA tablets whole or if you have a feeding tube. Read this Instructions for Use before you prepare and take or give the first dose of ERLEADA, and each time you get a refill. Ask your healthcare provider or pharmacist if you have any questions. Important information you need to know before preparing a dose of ERLEADA:ERLEADA comes in 2 different strengths, 60 mg tablets and 240 mg tablets. Please find the instructions below that refer to your prescribed ERLEADA strength for how to prepare and take or give ERLEADA tablets.
Preparing and taking ERLEADA if you cannot swallow tablets whole: Preparing and taking ERLEADA 60 mg tablets by placing the tablets in non-carbonated water then mixing with orange juice, applesauce, or more non-carbonated water:
Step 1.Place your entire prescribed dose of 60 mg tablets in a cup. Do not crush or split the tablets.
Step 2.Add about 4 teaspoons (20 mL) of non-carbonated water to make sure that the tablets are completely covered in water.
Step 3.Wait 2 minutes until the tablets are broken up and spread out, then stir the mixture.
Step 4.Add 2 tablespoons (30 mL) of orange juice, applesauce, or non-carbonated water to the cup and stir the mixture.
Step 5.Swallow the mixture right away.
Step 6.Rinse the cup with enough non-carbonated water to make sure that you take your full dose of ERLEADA and drink it right away.
Do not store ERLEADA that is mixed with non-carbonated water, orange juice, or applesauce for later use.
Preparing and taking ERLEADA 240 mg tablet by placing the tablet in non-carbonated water then mixing with orange juice, applesauce, or more non-carbonated water:
Step 1.Place the whole 240 mg tablet in a cup. Do not crush or split the tablet.
Step 2.Add about 2 teaspoons (10 mL) of non-carbonated water to make sure that the tablet is completely covered in water.
Step 3.Wait 2 minutes until the tablet is broken up and spread out, then stir the mixture.
Step 4.Add 2 tablespoons (30 mL) of orange juice, applesauce, or non-carbonated water to the cup and stir the mixture.
Step 5.Swallow the mixture right away.
Step 6.Rinse the cup with enough non-carbonated water to make sure that you take your full dose of ERLEADA and drink it right away.
Do not store ERLEADA that is mixed with non-carbonated water, orange juice, or applesauce for later use.
Preparing and giving ERLEADA through a feeding tube: Preparing and giving ERLEADA 60 mg tablets through a feeding tube 8 French or larger:
Step 1.Remove the plunger out of the syringe (use at least a 50 mL syringe).
Step 2.Add your entire prescribed dose of 60 mg tablets into the syringe body (barrel) and place the plunger back in the syringe. Do not crush or split the tablets.
Step 3.Withdraw 20 mL of non-carbonated water into the syringe.
Step 4.Wait 10 minutes and then shake the syringe very well (vigorously) to break the tablets apart completely.
Step 5.Attach the syringe to the feeding tube and give the mixture right away.
Step 6.Withdraw non-carbonated water into the same syringe and flush through the feeding tube. Repeat Step 6 until no pieces of tablets are left in the syringe or feeding tube.
Preparing and giving ERLEADA 240 mg tablet through a feeding tube 8 French or larger:
Step 1.Remove the plunger out of the syringe (use at least a 20 mL syringe).
Step 2.Add one 240 mg tablet into the syringe body (barrel) and place the plunger back in the syringe. Do not crush or split the tablet.
Step 3.Withdraw 10 mL of non-carbonated water into the syringe.
Step 4.Wait 10 minutes and then shake the syringe very well (vigorously) to break the tablet apart completely.
Step 5.Attach the syringe to the feeding tube and give the mixture right away.
Step 6.Withdraw non-carbonated water into the same syringe and flush through the feeding tube. Repeat Step 6 until no pieces of tablet are left in the syringe or feeding tube.
How should I store ERLEADA?Store ERLEADA at room temperature between 68 °F to 77 °F (20 °C to 25 °C).ERLEADA comes in a child-resistant bottle.Store ERLEADA in the original package to protect from light and moisture.The bottle of ERLEADA contains a desiccant packet to help keep your medicine dry (protect it from moisture). Do not throw away (discard) the desiccant.Keep ERLEADA and all medicines out of the reach of children. Manufactured for: Janssen Products, LP, Horsham, PA 19044, USA For patent information: www.janssenpatents.com © 2019, 2023 Janssen Pharmaceutical Companies For more information, call Janssen Products, LP at 1-800-526-7736 (1-800-JANSSEN) or go to www.erleada.com.
"],"recent_major_changes_table":["
Dosage and Administration, Recommended Dosage (2.1, 2.2, 2.3)03/2026
"],"spl_patient_package_insert":["This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 03/2026 PATIENT INFORMATION ERLEADA ® ( er lee'dah ) (apalutamide) tablets What is ERLEADA? ERLEADA is a prescription medicine used for the treatment of prostate cancer: that has spread to other parts of the body and still responds to a medical or surgical treatment that lowers testosterone, OR that has not spread to other parts of the body and no longer responds to a medical or surgical treatment that lowers testosterone. It is not known if ERLEADA is safe and effective in females. It is not known if ERLEADA is safe and effective in children. Before taking ERLEADA, tell your healthcare provider about all your medical conditions, including if you: have a history of heart disease have high blood pressure have diabetes have abnormal amounts of fat or cholesterol in your blood (dyslipidemia) have liver problems have a history of seizures, brain injury, stroke, or brain tumors are pregnant or plan to become pregnant. ERLEADA can cause harm to your unborn baby and loss of pregnancy (miscarriage). have a partner who is pregnant or may become pregnant. Males who have female partners who are able to become pregnant should use effective birth control (contraception) during treatment and for 3 months after the last dose of ERLEADA. Males should use a condom during sex with a pregnant female. Talk with your healthcare provider if you have questions about birth control. are breastfeeding or plan to breastfeed. It is not known if ERLEADA passes into breast milk. Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. ERLEADA can interact with many other medicines. You should not start or stop any medicine before you talk with the healthcare provider that prescribed ERLEADA. Know the medicines you take. Keep a list of them with you to show to your healthcare provider and pharmacist when you get a new medicine. How should I take ERLEADA? Take ERLEADA exactly as your healthcare provider tells you. Do not stop taking your prescribed dose of ERLEADA without talking with your healthcare provider first. Take your prescribed dose of ERLEADA 1 time a day, at the same time each day. Take ERLEADA with or without food. Swallow ERLEADA tablets whole. Do not crush or split the tablets. If you cannot swallow ERLEADA tablets whole or if you have a feeding tube, see the \" Instructions for Use \" for detailed instructions on how to prepare and take a dose of ERLEADA. ERLEADA comes in 2 different strengths (60 mg and 240 mg). Follow the instructions for your prescribed strength of ERLEADA. If you miss a dose of ERLEADA, take your normal dose as soon as possible on the same day. Return to your normal schedule on the following day. You should not take extra tablets to make up the missed dose. You should start or continue a gonadotropin-releasing hormone (GnRH) analog therapy during your treatment with ERLEADA unless you have had a surgery to lower the amount of testosterone in your body (surgical castration). If you take too much ERLEADA, call your healthcare provider or go to the nearest hospital emergency room. What are the possible side effects of ERLEADA? ERLEADA may cause serious side effects including: Heart disease, stroke, or mini-stroke. Bleeding in the brain or blockage of the arteries in the heart or in part of the brain have happened in some people during treatment with ERLEADA and can lead to death. Your healthcare provider will monitor you for signs and symptoms of heart or brain problems during your treatment with ERLEADA. Call your healthcare provider or get medical help right away if you get: chest pain or discomfort at rest or with activity shortness of breath numbness or weakness of the face, arm, or leg, especially on one side of the body trouble talking or understanding trouble seeing in one or both eyes dizziness, loss of balance or coordination, or trouble walking Fractures and falls. ERLEADA treatment can cause bones and muscles to weaken and may increase your risk for falls and fractures. Falls and fractures have happened in people during treatment with ERLEADA. Your healthcare provider will monitor your risks for falls and fractures during treatment with ERLEADA. Seizure. Treatment with ERLEADA may increase your risk of having a seizure. You should avoid activities where a sudden loss of consciousness could cause serious harm to yourself or others. Tell your healthcare provider right away if you have a loss of consciousness or seizure. Your healthcare provider will stop ERLEADA if you have a seizure during treatment. Severe skin reactions. Treatment with ERLEADA may cause severe skin reactions that can lead to death or be life-threatening. Stop taking ERLEADA and tell your healthcare provider or get medical help right away if you develop any of these signs or symptoms of a severe skin reaction: severe rash or rash that continues to get worse fever or flu-like symptoms swollen lymph nodes blisters or sores in the mouth, throat, nose, eyes, or genital area blistering or peeling of the skin Lung problems. Treatment with ERLEADA may cause inflammation of the lungs that can lead to death or be life-threatening. Stop taking ERLEADA and tell your healthcare provider or get medical help right away if you develop any new or worsening symptoms of lung problems, including: shortness of breath cough fever The most common side effects of ERLEADA include: feeling very tired joint pain rash. Tell your healthcare provider if you get a rash. decreased appetite fall weight loss high blood pressure hot flash diarrhea fracture Your healthcare provider may reduce your dose, temporarily stop, or permanently stop treatment with ERLEADA if you have certain side effects. ERLEADA may cause fertility problems in males, which may affect the ability to father children. Talk to your healthcare provider if you have concerns about fertility. Do not donate sperm during treatment with ERLEADA and for 3 months after the last dose of ERLEADA. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of ERLEADA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store ERLEADA? Store ERLEADA at room temperature between 68 °F to 77 °F (20 °C to 25 °C). ERLEADA comes in a child-resistant bottle. Store ERLEADA in the original package to protect from light and moisture. The bottle of ERLEADA contains a desiccant packet to help keep your medicine dry (protect it from moisture). Do not throw away (discard) the desiccant. Keep ERLEADA and all medicines out of the reach of children. General information about the safe and effective use of ERLEADA. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ERLEADA for a condition for which it was not prescribed. Do not give ERLEADA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about ERLEADA that is written for health professionals. What are the ingredients in ERLEADA? Active ingredient: apalutamide Inactive ingredients: 240 mg film-coated tablets: colloidal anhydrous silica, croscarmellose sodium, hydroxypropyl methylcellulose-acetate succinate, silicified microcrystalline cellulose, and magnesium stearate. The coating contains glyceryl monocaprylocaprate, iron oxide black, polyvinyl alcohol, talc, titanium dioxide, and vinyl alcohol grafted copolymer. 60 mg film-coated tablets: colloidal anhydrous silica, croscarmellose sodium, hydroxypropyl methylcellulose-acetate succinate, magnesium stearate, microcrystalline cellulose, and silicified microcrystalline cellulose. The coating contains iron oxide black, iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Manufactured for: Janssen Products, LP, Horsham, PA 19044, USA For patent information: www.janssenpatents.com © 2019, 2023 Janssen Pharmaceutical Companies For more information, call Janssen Products, LP at 1-800-526-7736 (1-800-JANSSEN) or go to www.erleada.com."],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary The safety and efficacy of ERLEADA have not been established in females. Based on findings from animals and its mechanism of action, ERLEADA can cause fetal harm and loss of pregnancy when administered to a pregnant female [see Clinical Pharmacology (12.1) ] . There are no available data on ERLEADA use in pregnant women to inform a drug-associated risk. In an animal reproduction study, oral administration of apalutamide to pregnant rats during and after organogenesis resulted in fetal abnormalities and embryo-fetal lethality at maternal exposures ≥ 2 times the human clinical exposure (AUC) at the recommended dose (see Data ) . Data Animal Data In a pilot embryo-fetal developmental toxicity study in rats, apalutamide caused developmental toxicity when administered at oral doses of 25, 50 or 100 mg/kg/day throughout and after the period of organogenesis (gestational days 6–20). Findings included embryo-fetal lethality (resorptions) at doses ≥50 mg/kg/day, decreased fetal anogenital distance, misshapen pituitary gland, and skeletal variations (unossified phalanges, supernumerary short thoracolumbar rib(s), and small, incomplete ossification, and/or misshapen hyoid bone) at ≥25 mg/kg/day. A dose of 100 mg/kg/day caused maternal toxicity. The doses tested in rats resulted in systemic exposures (AUC) approximately 2, 4 and 6 times, respectively, the AUC in patients. 8.2 Lactation Risk Summary The safety and efficacy of ERLEADA have not been established in females. There are no data on the presence of apalutamide or its metabolites in human milk, the effect on the breastfed child, or the effect on milk production. 8.3 Females and Males of Reproductive Potential Contraception Males Based on the mechanism of action and findings in an animal reproduction study, advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of ERLEADA [see Use in Specific Populations (8.1) ] . Infertility Males Based on animal studies, ERLEADA may impair fertility in males of reproductive potential [see Nonclinical Toxicology (13.1) ] . 8.4 Pediatric Use Safety and effectiveness of ERLEADA in pediatric patients have not been established. 8.5 Geriatric Use Of the 1327 patients who received ERLEADA in clinical studies, 19% of patients were less than 65 years, 41% of patients were 65 years to 74 years, and 40% were 75 years and over. No overall differences in effectiveness were observed between older and younger patients. Of patients treated with ERLEADA (n=1073), Grade 3–4 adverse reactions occurred in 39% of patients younger than 65 years, 41% of patients 65–74 years, and 49% of patients 75 years or older. Falls in patients receiving ERLEADA with androgen deprivation therapy was elevated in the elderly, occurring in 8% of patients younger than 65 years, 10% of patients 65–74 years, and 19% of patients 75 years or older. 8.6 Hepatic Impairment The recommended ERLEADA dosage in patients with severe hepatic impairment (Child-Pugh C) is lower than the recommended dosage in patients with normal hepatic function [see Dosage and Administration (2.3) ] . No dosage modification is recommended for patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment [see Clinical Pharmacology (12.3) ] ."],"spl_patient_package_insert_table":["
This Patient Information has been approved by the U.S. Food and Drug Administration.Revised: 03/2026
PATIENT INFORMATION ERLEADA® (er lee'dah) (apalutamide) tablets
What is ERLEADA? ERLEADA is a prescription medicine used for the treatment of prostate cancer:that has spread to other parts of the body and still responds to a medical or surgical treatment that lowers testosterone, OR that has not spread to other parts of the body and no longer responds to a medical or surgical treatment that lowers testosterone.It is not known if ERLEADA is safe and effective in females. It is not known if ERLEADA is safe and effective in children.
Before taking ERLEADA, tell your healthcare provider about all your medical conditions, including if you:have a history of heart diseasehave high blood pressurehave diabeteshave abnormal amounts of fat or cholesterol in your blood (dyslipidemia)have liver problemshave a history of seizures, brain injury, stroke, or brain tumorsare pregnant or plan to become pregnant. ERLEADA can cause harm to your unborn baby and loss of pregnancy (miscarriage).have a partner who is pregnant or may become pregnant.Males who have female partners who are able to become pregnant should use effective birth control (contraception) during treatment and for 3 months after the last dose of ERLEADA.Males should use a condom during sex with a pregnant female.Talk with your healthcare provider if you have questions about birth control.are breastfeeding or plan to breastfeed. It is not known if ERLEADA passes into breast milk.Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ERLEADA can interact with many other medicines. You should not start or stop any medicine before you talk with the healthcare provider that prescribed ERLEADA. Know the medicines you take. Keep a list of them with you to show to your healthcare provider and pharmacist when you get a new medicine.
How should I take ERLEADA?Take ERLEADA exactly as your healthcare provider tells you.Do not stop taking your prescribed dose of ERLEADA without talking with your healthcare provider first.Take your prescribed dose of ERLEADA 1 time a day, at the same time each day.Take ERLEADA with or without food.Swallow ERLEADA tablets whole. Do not crush or split the tablets.If you cannot swallow ERLEADA tablets whole or if you have a feeding tube, see the "Instructions for Use" for detailed instructions on how to prepare and take a dose of ERLEADA. ERLEADA comes in 2 different strengths (60 mg and 240 mg). Follow the instructions for your prescribed strength of ERLEADA.If you miss a dose of ERLEADA, take your normal dose as soon as possible on the same day. Return to your normal schedule on the following day. You should not take extra tablets to make up the missed dose.You should start or continue a gonadotropin-releasing hormone (GnRH) analog therapy during your treatment with ERLEADA unless you have had a surgery to lower the amount of testosterone in your body (surgical castration).If you take too much ERLEADA, call your healthcare provider or go to the nearest hospital emergency room.
What are the possible side effects of ERLEADA? ERLEADA may cause serious side effects including:Heart disease, stroke, or mini-stroke. Bleeding in the brain or blockage of the arteries in the heart or in part of the brain have happened in some people during treatment with ERLEADA and can lead to death. Your healthcare provider will monitor you for signs and symptoms of heart or brain problems during your treatment with ERLEADA. Call your healthcare provider or get medical help right away if you get:
chest pain or discomfort at rest or with activityshortness of breathnumbness or weakness of the face, arm, or leg, especially on one side of the bodytrouble talking or understandingtrouble seeing in one or both eyesdizziness, loss of balance or coordination, or trouble walking
Fractures and falls. ERLEADA treatment can cause bones and muscles to weaken and may increase your risk for falls and fractures. Falls and fractures have happened in people during treatment with ERLEADA. Your healthcare provider will monitor your risks for falls and fractures during treatment with ERLEADA.Seizure. Treatment with ERLEADA may increase your risk of having a seizure. You should avoid activities where a sudden loss of consciousness could cause serious harm to yourself or others. Tell your healthcare provider right away if you have a loss of consciousness or seizure. Your healthcare provider will stop ERLEADA if you have a seizure during treatment.Severe skin reactions. Treatment with ERLEADA may cause severe skin reactions that can lead to death or be life-threatening. Stop taking ERLEADA and tell your healthcare provider or get medical help right away if you develop any of these signs or symptoms of a severe skin reaction:
severe rash or rash that continues to get worsefever or flu-like symptomsswollen lymph nodesblisters or sores in the mouth, throat, nose, eyes, or genital areablistering or peeling of the skin
Lung problems. Treatment with ERLEADA may cause inflammation of the lungs that can lead to death or be life-threatening. Stop taking ERLEADA and tell your healthcare provider or get medical help right away if you develop any new or worsening symptoms of lung problems, including:
shortness of breathcoughfever
The most common side effects of ERLEADA include:
feeling very tiredjoint painrash. Tell your healthcare provider if you get a rash.decreased appetitefallweight losshigh blood pressurehot flashdiarrheafracture
Your healthcare provider may reduce your dose, temporarily stop, or permanently stop treatment with ERLEADA if you have certain side effects. ERLEADA may cause fertility problems in males, which may affect the ability to father children. Talk to your healthcare provider if you have concerns about fertility. Do not donate sperm during treatment with ERLEADA and for 3 months after the last dose of ERLEADA. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of ERLEADA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store ERLEADA?Store ERLEADA at room temperature between 68 °F to 77 °F (20 °C to 25 °C).ERLEADA comes in a child-resistant bottle.Store ERLEADA in the original package to protect from light and moisture.The bottle of ERLEADA contains a desiccant packet to help keep your medicine dry (protect it from moisture). Do not throw away (discard) the desiccant.Keep ERLEADA and all medicines out of the reach of children.
General information about the safe and effective use of ERLEADA. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ERLEADA for a condition for which it was not prescribed. Do not give ERLEADA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about ERLEADA that is written for health professionals.
What are the ingredients in ERLEADA? Active ingredient: apalutamide Inactive ingredients: 240 mg film-coated tablets: colloidal anhydrous silica, croscarmellose sodium, hydroxypropyl methylcellulose-acetate succinate, silicified microcrystalline cellulose, and magnesium stearate. The coating contains glyceryl monocaprylocaprate, iron oxide black, polyvinyl alcohol, talc, titanium dioxide, and vinyl alcohol grafted copolymer. 60 mg film-coated tablets: colloidal anhydrous silica, croscarmellose sodium, hydroxypropyl methylcellulose-acetate succinate, magnesium stearate, microcrystalline cellulose, and silicified microcrystalline cellulose. The coating contains iron oxide black, iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Manufactured for: Janssen Products, LP, Horsham, PA 19044, USA For patent information: www.janssenpatents.com © 2019, 2023 Janssen Pharmaceutical Companies For more information, call Janssen Products, LP at 1-800-526-7736 (1-800-JANSSEN) or go to www.erleada.com.
"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 60 mg Tablet Bottle Label NDC 59676-600-12 Erleada ® (apalutamide) tablets 60 mg Each film-coated tablet contains 60 mg of apalutamide. This package is child-resistant. Keep out of reach of children. Rx only 120 film-coated tablets 60 mg","PRINCIPAL DISPLAY PANEL - 240 mg Tablet Bottle Label NDC 59676-604-30 Erleada ® (apalutamide) tablets 240 mg Each film-coated tablet contains 240 mg of apalutamide. This package is child-resistant. Keep out of reach of children. Rx only 30 film-coated tablets 240 mg"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility In a 2-year carcinogenicity study in male rats, apalutamide was administered by oral gavage at doses of 5, 15 and 50 mg/kg/day. Apalutamide increased the incidence of Leydig interstitial cell adenoma in the testes at doses ≥ 5 mg/kg/day (0.2 times the human exposure based on AUC). The findings in the testes are considered to be related to the pharmacological activity of apalutamide. Rats are regarded as more sensitive than humans to developing interstitial cell tumors in the testes. Oral administration of apalutamide to male rasH2 transgenic mice for 6 months did not result in increased incidence of neoplasms at doses up to 30 mg/kg/day. Apalutamide did not induce mutations in the bacterial reverse mutation (Ames) assay and was not genotoxic in either in vitro chromosome aberration assay or the in vivo rat bone marrow micronucleus assay or the in vivo rat Comet assay. In repeat-dose toxicity studies in male rats (up to 26 weeks) and dogs (up to 39 weeks), atrophy of the prostate gland and seminal vesicles, aspermia/hypospermia, tubular degeneration and/or hyperplasia or hypertrophy of the interstitial cells in the reproductive system were observed at ≥ 25 mg/kg/day in rats (1.4 times the human exposure based on AUC) and ≥ 2.5 mg/kg/day in dogs (0.9 times the human exposure based on AUC). In a fertility study in male rats, a decrease in sperm concentration and motility, increased abnormal sperm morphology, lower copulation and fertility rates (upon pairing with untreated females) along with reduced weights of the secondary sex glands and epididymis were observed following 4 weeks of dosing at ≥ 25 mg/kg/day (0.8 times the human exposure based on AUC). A reduced number of live fetuses due to increased pre- and/or post-implantation loss was observed following 4 weeks of 150 mg/kg/day administration (5.7 times the human exposure based on AUC). Effects on male rats were reversible after 8 weeks from the last apalutamide administration."]},"tags":[{"label":"Small Molecule","category":"modality"},{"label":"Androgen receptor","category":"target"},{"label":"AR","category":"gene"},{"label":"L02BB05","category":"atc"},{"label":"Oral","category":"route"},{"label":"Tablet","category":"form"},{"label":"Generic Available","category":"availability"},{"label":"LOE Approaching","category":"status"},{"label":"Castration-resistant prostate cancer","category":"indication"},{"label":"Malignant tumor of prostate","category":"indication"},{"label":"Metastasis from malignant tumor of prostate","category":"indication"},{"label":"Janssen Biotech","category":"company"},{"label":"Approved 2010s","category":"decade"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"RASH","source":"FDA FAERS","actionTaken":"1185 reports"},{"date":"","signal":"DEATH","source":"FDA FAERS","actionTaken":"1145 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"1093 reports"},{"date":"","signal":"HOT FLUSH","source":"FDA FAERS","actionTaken":"821 reports"},{"date":"","signal":"PRODUCT DOSE OMISSION ISSUE","source":"FDA FAERS","actionTaken":"430 reports"},{"date":"","signal":"ASTHENIA","source":"FDA FAERS","actionTaken":"405 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"384 reports"},{"date":"","signal":"DIZZINESS","source":"FDA FAERS","actionTaken":"346 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"343 reports"},{"date":"","signal":"ARTHRALGIA","source":"FDA FAERS","actionTaken":"329 reports"}],"commonSideEffects":[{"effect":"Fatigue","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Rash","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Hypertension","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Hot flush","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Arthralgia","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Diarrhea","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Decreased appetite","drugRate":"reported","severity":"common"},{"effect":"Fall","drugRate":"reported","severity":"common"},{"effect":"Weight decreased","drugRate":"reported","severity":"common"},{"effect":"Fracture","drugRate":"3.4%","severity":"serious","_validated":true},{"effect":"Pruritus","drugRate":"1.0%","severity":"common","_validated":true},{"effect":"Vomiting","drugRate":"reported","severity":"common"},{"effect":"Nausea","drugRate":"reported","severity":"common"},{"effect":"Hematuria","drugRate":"reported","severity":"common"},{"effect":"Muscle spasm","drugRate":"3.1%","severity":"common","_validated":true},{"effect":"Dysgeusia","drugRate":"3.2%","severity":"common","_validated":true},{"effect":"Hypothyroidism","drugRate":"3.6%","severity":"common","_validated":true},{"effect":"Urinary retention","drugRate":"3.8%","severity":"serious","_validated":true},{"effect":"Cardio-respiratory arrest","drugRate":"reported","severity":"serious"},{"effect":"Sudden cardiac death","drugRate":"reported","severity":"serious"},{"effect":"Respiratory failure","drugRate":"reported","severity":"serious"},{"effect":"Cerebrovascular accident","drugRate":"reported","severity":"serious"},{"effect":"Large intestinal ulcer perforation","drugRate":"reported","severity":"serious"},{"effect":"Ischemic cardiovascular events","drugRate":"reported","severity":"serious"},{"effect":"Acute kidney injury","drugRate":"reported","severity":"serious"},{"effect":"Infection","drugRate":"reported","severity":"serious"},{"effect":"Myocardial infarction","drugRate":"reported","severity":"serious"}],"contraindications":["Pregnancy, function"],"specialPopulations":{"Pregnancy":"The safety and efficacy of ERLEADA have not been established in females. Based on findings from animals and its mechanism of action, ERLEADA can cause fetal harm and loss of pregnancy when administered to pregnant female. There are no available data on ERLEADA use in pregnant women to inform drug-associated risk. In an animal reproduction study, oral administration of apalutamide to pregnant rats during and after organogenesis resulted in fetal abnormalities and embryo-fetal lethality at maternal exposures >= times the human clinical exposure (AUC) at the recommended dose.","Geriatric use":"Of the 1327 patients who received ERLEADA in clinical studies, 19% of patients were less than 65 years, 41% of patients were 65 years to 74 years, and 40% were 75 years and over.No overall differences in effectiveness were observed between older and younger patients.Of patients treated with ERLEADA (n=1073), Grade 3-4 adverse reactions occurred in 39% of patients younger than 65 years, 41% of patients 65-74 years, and 49% of patients 75 years or older. Falls in patients receiving ERLEADA were more common in patients 75 years or older.","Paediatric use":"Safety and effectiveness of ERLEADA in pediatric patients have not been established."}},"trials":[],"aliases":[],"company":"Johnson & Johnson","patents":[{"applNo":"N210951","source":"FDA Orange Book","status":"Active","expires":"Mar 27, 2027","useCode":"U-2237","territory":"US","drugProduct":false,"patentNumber":"8802689","drugSubstance":false},{"applNo":"N210951","source":"FDA Orange Book","status":"Active","expires":"Sep 23, 2033","useCode":"U-2237","territory":"US","drugProduct":false,"patentNumber":"9884054","drugSubstance":false},{"applNo":"N210951","source":"FDA Orange Book","status":"Active","expires":"Sep 15, 2030","useCode":"U-2624","territory":"US","drugProduct":true,"patentNumber":"8445507","drugSubstance":true},{"applNo":"N210951","source":"FDA Orange Book","status":"Active","expires":"Jan 30, 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It is used to treat castration-resistant prostate cancer, including metastasis from malignant tumors of the prostate. Erleada was FDA-approved in 2018 and is currently patented. As a small molecule, it works by blocking the androgen receptor, which is a protein that helps cancer cells grow. Key safety considerations include potential side effects such as fatigue, diarrhea, and high blood pressure.","brandName":"Erleada","ecosystem":[{"indication":"Castration-resistant prostate cancer","otherDrugs":[],"globalPrevalence":null},{"indication":"Malignant tumor of prostate","otherDrugs":[{"name":"abiraterone acetate","slug":"abiraterone-acetate","company":"Janssen Biotech"},{"name":"docetaxel","slug":"docetaxel","company":"Sanofi Aventis Us"},{"name":"enzalutamide","slug":"enzalutamide","company":"Astellas"},{"name":"radium Ra 223 dichloride","slug":"radium-ra-223-dichloride","company":"Bayer Hlthcare"}],"globalPrevalence":null},{"indication":"Metastasis from malignant tumor of prostate","otherDrugs":[{"name":"enzalutamide","slug":"enzalutamide","company":"Astellas"}],"globalPrevalence":null}],"mechanism":{"target":"Androgen receptor","novelty":"Follow-on","targets":[{"gene":"AR","source":"DrugCentral","target":"Androgen receptor","protein":"Androgen receptor"}],"modality":"Small Molecule","explanation":"Apalutamide is an Androgen Receptor (AR) inhibitor that binds directly to the ligand-binding domain of the AR. Apalutamide inhibits AR nuclear translocation, inhibits DNA binding, and impedes AR-mediated transcription. major metabolite, N-desmethyl apalutamide, is less potent inhibitor of AR, and exhibited one-third the activity of apalutamide in an in vitro transcriptional reporter assay. Apalutamide administration caused decreased tumor cell proliferation and increased apoptosis leading to decreased tumor volume in mouse xenograft models of prostate cancer.","oneSentence":"Erleada blocks the androgen receptor, a protein that helps cancer cells grow.","technicalDetail":"Apalutamide is a non-steroidal androgen receptor inhibitor that selectively binds to the androgen receptor, preventing its activation and subsequent transcription of androgen-dependent genes."},"commercial":{"launchDate":"2018","revenueYear":2024,"_launchSource":"DrugCentral (FDA 2018-02-14, JANSSEN BIOTECH)","annualRevenue":2600,"revenueSource":"J&J AR 2024 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