{"id":"bicalutamide","rwe":[{"pmid":"41900824","year":"2026","title":"Improved Anticancer Properties of Silver Nanoparticles by Albumin Coating in Prostate Cancer Cell Lines: An In Vitro Study.","finding":"","journal":"Pharmaceutics","studyType":"Clinical Study"},{"pmid":"41899391","year":"2026","title":"Correction: Chen et al. Bicalutamide Exhibits Potential to Damage Kidney via Destroying Complex I and Affecting Mitochondrial Dynamics. J. Clin. Med. 2022, 11, 135.","finding":"","journal":"Journal of clinical medicine","studyType":"Clinical Study"},{"pmid":"41884527","year":"2026","title":"Cervical Lymphadenopathy as Initial Presentation of Foamy Gland Adenocarcinoma of the Prostate: A Case Report.","finding":"","journal":"OncoTargets and therapy","studyType":"Clinical Study"},{"pmid":"41864472","year":"2026","title":"Androgen receptor-NOX4-necroptosis axis drives male-biased susceptibility in aristolochic acid-induced acute kidney injury.","finding":"","journal":"Chemico-biological interactions","studyType":"Clinical Study"},{"pmid":"41815147","year":"2026","title":"Neoadjuvant androgen deprivation therapy with bicalutamide compared to hormonal agents in treating high-risk prostate cancer: a real-world cohort study.","finding":"","journal":"Translational cancer research","studyType":"Clinical Study"}],"_fda":{"id":"10e21544-f181-4cf8-9824-df0f49d19511","set_id":"10e21544-f181-4cf8-9824-df0f49d19511","openfda":{"nui":["N0000000243","N0000175560"],"upc":["0382804082902"],"unii":["A0Z3NAU9DP"],"route":["ORAL"],"rxcui":["199123"],"spl_id":["10e21544-f181-4cf8-9824-df0f49d19511"],"brand_name":["bicalutamide"],"spl_set_id":["10e21544-f181-4cf8-9824-df0f49d19511"],"package_ndc":["82804-082-90"],"product_ndc":["82804-082"],"generic_name":["BICALUTAMIDE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["BICALUTAMIDE"],"pharm_class_epc":["Androgen Receptor Inhibitor [EPC]"],"pharm_class_moa":["Androgen Receptor Antagonists [MoA]"],"manufacturer_name":["Proficient Rx LP"],"application_number":["ANDA079110"],"original_packager_product_ndc":["47335-485"]},"version":"1","pregnancy":["8.1 Pregnancy Risk Summary Bicalutamide is contraindicated for use in pregnant women because it can cause fetal harm. Bicalutamide is not indicated for use in females. There are no human data on the use of bicalutamide in pregnant women. In animal reproduction studies, oral administration of bicalutamide to pregnant rats during organogenesis caused abnormal development of reproductive organs in male fetuses at exposures approximately 0.7 to 2 times the human exposure at the recommended dose (see Data). Data Animal Data In an embryo-fetal development study in pregnant rats dosed during the period of organogenesis from gestation days 6-15, male fetuses had reduced anogenital distance at doses of 10 mg/kg/day and above (approximately 0.7 to 2 times the human exposure at the recommended dose). In a pre- and post-natal development study, female rats were dosed from gestation day 7-16 and allowed to litter and rear their offspring to weaning. Male offspring of rats receiving doses of 10 mg/kg/day (approximately 0.7 times the human exposure at the recommended dose) and above, were observed to have reduced anogenital distance. In a peri- and post-natal development study, female rats were dosed from gestation day 16 to lactation day 22 and allowed to litter and rear their offspring to weaning. Survival and weights of offspring during lactation were reduced for litters from maternal rats receiving doses of 250 mg/kg/day (approximately 2 times the human exposure at the recommended dose). Male offspring of rats receiving doses of 10 mg/kg/day (approximately 0.7 times the human exposure at the recommended dose) and above, were observed to have reduced anogenital distance, smaller secondary sex organs, cryptorchidism and hypospadias resulting in an inability to mate and impregnate their female partners. Female offspring of rats receiving doses of 10 mg/kg/day (approximately 0.7 times the human exposure at the recommended dose) and above had reduced pregnancy rates."],"overdosage":["10 OVERDOSAGE Long-term clinical trials have been conducted with dosages up to 200 mg of bicalutamide daily and these dosages have been well tolerated. A single dose of bicalutamide that results in symptoms of an overdose considered to be life threatening has not been established. There is no specific antidote; treatment of an overdose should be symptomatic. In the management of an overdose with bicalutamide, vomiting may be induced if the patient is alert. It should be remembered that, in this patient population, multiple drugs may have been taken. Dialysis is not likely to be helpful since bicalutamide is highly protein bound and is extensively metabolized. General supportive care, including frequent monitoring of vital signs and close observation of the patient, is indicated."],"description":["11 DESCRIPTION Bicalutamide tablets contain 50 mg of bicalutamide USP, a non-steroidal androgen receptor inhibitor with no other known endocrine activity. The chemical name is propanamide, N [4 cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)sulfonyl]-2-hydroxy-2-methyl-,(+-). The structural and molecular formulas are: Bicalutamide has a molecular weight of 430.37. The pKa is approximately 12. Bicalutamide is a fine white to off-white powder which is practically insoluble in water at 37°C (5 mg per 1000 mL), slightly soluble in chloroform and absolute ethanol, sparingly soluble in methanol, and soluble in acetone and tetrahydrofuran. Bicalutamide tablet is a racemate with its antiandrogenic activity being almost exclusively exhibited by the R-enantiomer of bicalutamide; the S-enantiomer is essentially inactive. The inactive ingredients of bicalutamide tablets are lactose monohydrate, sodium starch glycolate type A, povidone, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide. bicalutamide-structure"],"how_supplied":["16 HOW SUPPLIED/STORAGE AND HANDLING White to off white, circular, biconvex, film-coated tablets debossed with “485” on one side and plain on other side. Bottles of 90…..…….…..…….…..…….…..…….…..…….NDC 82804-082-90 16.1 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]."],"geriatric_use":["8.5 Geriatric Use In two studies in patients given 50 mg or 150 mg daily, no significant relationship between age and steady-state levels of total bicalutamide or the active R-enantiomer has been shown."],"pediatric_use":["8.4 Pediatric Use The safety and effectiveness of bicalutamide in pediatric patients have not been established. Bicalutamide orodispersible tablet was studied in combination with Arimidex # (anastrozole) orodispersible tablet in an open-label, non-comparative, multi-center study that assessed the efficacy and safety of this combination regimen over 12 months in the treatment of gonadotropin-independent precocious puberty in boys with familial male-limited precocious puberty, also known as testotoxicosis. Patients were enrolled in the study if they had a baseline age ≥2 years and a diagnosis of testotoxicosis based on clinical features of progressive precocious puberty, symmetrical testicular enlargement, advanced bone age, pubertal levels of serum testosterone, prepubertal pattern of gonadotropin secretion following a GnRH stimulation test, and absence of other clinical and biochemical causes of testosterone excess. Thirteen out of the 14 patients enrolled completed 12 months of combination treatment (one patient was lost to follow-up). If central precocious puberty (CPP) developed, an LHRH analog was to be added. Four patients were diagnosed with CPP during the 12-month study and received LHRH analog treatment and 2 additional patients were diagnosed at the end of the 12 months and received treatment subsequently. Mean ± SD characteristics at baseline were as follows: chronological age: 3.9±1.9 years; bone age 8.8±2.5; bone age/chronological age ratio: 2.06±0.51; growth rate (cm/yr): 10.81±4.22; growth rate standard deviation score (SDS): 0.41±1.36. The starting bicalutamide dose was 12.5 mg. Bicalutamide was titrated in each patient until steady-state R-bicalutamide (the active isomer of bicalutamide) trough plasma concentration reached 5 mcg/mL to 15 mcg/mL, which is the range of therapeutic concentrations achieved in adults with prostate cancer following the administration of the currently approved bicalutamide dose of 50 mg. The starting daily dose of anastrozole was 0.5 mg. Anastrozole was independently titrated in each patient until it reached at steady-state a serum estradiol concentration of <10 pmol/L (2.7 pg/mL). The following ascending doses were used for bicalutamide: 12.5 mg, 25 mg, 50 mg, and 100 mg. For anastrozole there were two ascending doses: 0.5 mg and 1 mg. At the end of the titration phase, 1 patient was on 12.5 mg bicalutamide, 8 patients were on 50 mg bicalutamide, and 4 patients were on 100 mg bicalutamide; 10 patients were on 0.5 mg anastrozole and 3 patients were on 1 mg anastrozole. In the majority of patients, steady-state trough concentrations of R-bicalutamide appeared to be attained by Day 21 with once daily dosing. Steady-state trough plasma anastrozole concentrations appeared to be attained by Day 8. The primary efficacy analysis of the study was to assess the change in growth rate after 12 months of treatment, relative to the growth rate during the ≥6 months prior to entering the study. Pre-study growth rates were obtained retrospectively. There was no statistical evidence that the growth rate was reduced during treatment. During bicalutamide / Arimidex # treatment the mean growth rate (cm/yr) decreased by 1.6 cm/year, 95% CI (-4.7 to 1.5) p=0.28; the mean growth rate SDS decreased by 0.1 SD, 95% CI (–1.2 to 1.0) p=0.88. Table 2 shows descriptive data for growth rates for the overall population and for subgroups defined by history of previous treatment for testotoxicosis with ketoconazole, spironolactone, anastrozole or other aromatase inhibitors. Table 2. Growth Rates Endpoint Analysis Population Pre-study Mean Change from pre-study to 12 months % patients with growth reduction Change compared to pre-study growth rate. Mean Median (Min, Max) Growth rate (cm/yr) All treated (n=13) 10.8 -1.6 -2.8 (-7.4, 8.4) 9/13 (69%) PT PT = Previous treatment for testotoxicosis with ketoconazole, spironolactone, anastrozole or other aromatase inhibitors. (n=6) 10.3 -0.2 -2.6 Median calculated as midpoint of 3rd and 4th ranked observations. (-7.2, 8.4) 4/6 (67%) NPT NPT = no previous treatment for testotoxicosis with ketoconazole, spironolactone, anastrozole, or other aromatase inhibitors. (n=7) 11.2 -2.8 -2.8 (-7.4, 1.1) 5/7 (71%) Growth rate (SD units) All treated (n=13) 0.4 -0.1 -0.4 (-2.7, 3.5) 9/13 (69%) PT (n=6) -0.1 +0.7 -0.2 (-1.6, 3.5) 4/6 (67%) NPT (n=7) 0.8 -0.7 -0.4 (-2.7, 0.5) 5/7 (71%) Total testosterone concentrations increased by a mean of 5 mmol/L over the 12 months of treatment from a baseline mean of 10 mmol/L. Estradiol concentrations were at or below the level of quantification (9.81 pmol/L) for 11 of 12 patients after 12 months of treatment. Six of the 12 patients started treatment at an estradiol concentration below the level of quantification. There were no deaths, serious adverse events, or discontinuations due to adverse events during the study. Of the 14 patients exposed to study treatment, 13 (92.9%) experienced at least one adverse event. The most frequently reported (>3 patients) adverse events were gynecomastia (7/14, 50%), central precocious puberty (6/14, 43%), vomiting (5/14, 36%), headache (3/14, 21%), pyrexia (3/14, 21%), and upper respiratory tract infection (3/14, 21%). Adverse reactions considered possibly related to bicalutamide by investigators included gynecomastia (6/14, 43%), central precocious puberty (2/14, 14%), breast tenderness (2/14, 14%), breast pain (1/14, 7%), asthenia (1/14, 7%), increased alanine aminotransferase [ALT] (1/14, 7%), increased aspartate aminotransferase [AST] (1/14, 7%), and musculoskeletal chest pain (1/14, 7%). Headache was the only adverse reaction considered possibly related to anastrozole by investigators. For the patient who developed elevated ALT and AST, the elevation was <3X ULN, and returned to normal without stopping treatment; there was no concomitant elevation in total bilirubin."],"effective_time":"20240301","nursing_mothers":["8.3 Females and Males of Reproductive Potential Contraception Males Antiandrogen therapy may cause morphological changes in spermatozoa [see Nonclinical Toxicology (13.1)]. Based on findings in animal reproduction studies and its mechanism of action, advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 130 days after the final dose of bicalutamide [see Use in Specific Populations (8.1) and Clinical Pharmacology (12.1)]. Infertility Males Based on animal studies, bicalutamide can lead to inhibition of spermatogenesis and may impair fertility in males of reproductive potential. The long-term effects of bicalutamide on male fertility have not been studied [see Nonclinical Toxicology (13.1)] ."],"clinical_studies":["14 CLINICAL STUDIES 14.1 Bicalutamide 50 mg Daily in Combination with an LHRH-A In a multi-center, double-blind, controlled clinical trial, 813 patients with previously untreated advanced prostate cancer were randomized to receive bicalutamide 50 mg once daily (404 patients) or flutamide 250 mg (409 patients) three times a day, each in combination with LHRH analogs (either goserelin acetate implant or leuprolide acetate depot). In an analysis conducted after a median follow-up of 160 weeks was reached, 213 (52.7%) patients treated with bicalutamide-LHRH analog therapy and 235 (57.5%) patients treated with flutamide-LHRH analog therapy had died. There was no significant difference in survival between treatment groups (see Figure 1). The hazard ratio for time to death (survival) was 0.87 (95% confidence interval 0.72 to 1.05). There was no significant difference in time to objective tumor progression between treatment groups (see Figure 2). Objective tumor progression was defined as the appearance of any bone metastases or the worsening of any existing bone metastases on bone scan attributable to metastatic disease, or an increase by 25% or more of any existing measurable extraskeletal metastases. The hazard ratio for time to progression of bicalutamide plus LHRH analog to that of flutamide plus LHRH analog was 0.93 (95% confidence interval, 0.79 to 1.10). Quality of life was assessed with self-administered patient questionnaires on pain, social functioning, emotional well being, vitality, activity limitation, bed disability, overall health, physical capacity, general symptoms, and treatment related symptoms. Assessment of the Quality of Life questionnaires did not indicate consistent significant differences between the two treatment groups. bicalutamide-figure-1 bicalutamide-figure-2 14.2 Safety Data from Clinical Studies using Bicalutamide 150 mg Bicalutamide 150 mg is not approved for use either alone or with other treatments. Two identical multi-center, randomized, open-label trials comparing bicalutamide 150 mg daily monotherapy to castration were conducted in patients that had locally advanced (T3-4, NX, M0) or metastatic (M1) prostate cancer. Monotherapy — M1 Group Bicalutamide 150 mg daily is not approved for use in patients with M1 cancer of the prostate. Based on an interim analysis of the two trials for survival, the Data Safety Monitoring Board recommended that bicalutamide treatment be discontinued in the M1 patients because the risk of death was 25% (HR 1.25, 95% CI 0.87 to 1.81) and 31% (HR 1.31, 95% CI 0.97 to 1.77) higher in the bicalutamide treated group compared to that in the castrated group, respectively. Locally Advanced (T3-4, NX, M0) Group Bicalutamide 150 mg daily is not approved for use in patients with locally advanced (T3-4, NX, M0) cancer of the prostate. Following discontinuation of all M1 patients, the trials continued with the T3-4, NX, M0 patients until study completion. In the larger trial (N=352), the risk of death was 25% (HR 1.25, 95% CI 0.92 to 1.71) higher in the bicalutamide group and in the smaller trial (N=140), the risk of death was 36% (HR 0.64, 95% CI, 0.39 to 1.03) lower in the bicalutamide group. In addition to the above two studies, there are three other ongoing clinical studies that provide additional safety information for bicalutamide 150 mg, a dose that is not approved for use. These are three multi-center, randomized, double-blind, parallel group trials comparing bicalutamide 150 mg daily monotherapy (adjuvant to previous therapy or under watchful waiting) with placebo, for death or time to disease progression, in a population of 8113 patients with localized or locally advanced prostate cancer. Bicalutamide 150 mg daily is not approved for use as therapy for patients with localized prostate cancer who are candidates for watchful waiting. Data from a planned subgroup analysis of two of these trials in 1627 patients with localized prostate cancer who were under watchful waiting, revealed a trend toward decreased survival in the bicalutamide arm after a median follow-up of 7.4 years. There were 294 (37.7%) deaths in the bicalutamidetreated patients versus 279 (32.9%) deaths in the placebo-treated patients (localized watchful waiting group) for a hazard ratio of 1.16 (95% CI 0.99 to 1.37)."],"pharmacokinetics":["12.3 Pharmacokinetics Absorption Bicalutamide is well-absorbed following oral administration, although the absolute bioavailability is unknown. Coadministration of bicalutamide with food has no clinically significant effect on rate or extent of absorption. Distribution Bicalutamide is highly protein-bound (96%) [see Drug Interactions (7)]. Metabolism/Elimination Bicalutamide undergoes stereospecific metabolism. The S (inactive) isomer is metabolized primarily by glucuronidation. The R (active) isomer also undergoes glucuronidation but is predominantly oxidized to an inactive metabolite followed by glucuronidation. Both the parent and metabolite glucuronides are eliminated in the urine and feces. The S-enantiomer is rapidly cleared relative to the R-enantiomer, with the R-enantiomer accounting for about 99% of total steady-state plasma levels. Pharmacokinetics of the active enantiomer of bicalutamide in normal males and patients with prostate cancer are presented in Table 3. Table 3. Pharmacokinetics of Bicalutamide Active Enantiomer Parameter Mean Standard Deviation Normal Males (n=30) Apparent Oral Clearance (L/hr) 0.320 0.103 Single Dose Peak Concentration (mcg/mL) 0.768 0.178 Single Dose Time to Peak Concentration (hours) 31.3 14.6 Half-life (days) 5.8 2.29 Patients with Prostate Cancer (n=40) C ss (mcg/mL) 8.939 3.504"],"adverse_reactions":["6 ADVERSE REACTIONS 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. Adverse reactions that occurred in more than 10% of patients receiving bicalutamide plus an LHRH-A were: hot flashes, pain (including general, back, pelvic and abdominal), asthenia, constipation, infection, nausea, peripheral edema, dyspnea, diarrhea, hematuria, nocturia, and anemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience In patients with advanced prostate cancer treated with bicalutamide in combination with an LHRH analog, the most frequent adverse reaction was hot flashes (53%). In the multi-center, double-blind, controlled clinical trial comparing bicalutamide 50 mg once daily with flutamide 250 mg three times a day, each in combination with an LHRH analog, the following adverse reactions with an incidence of 5% or greater, regardless of causality, have been reported. Table 1 Incidence of Adverse Reactions (≥ 5% in Either Treatment Group) Regardless of Causality Body System Adverse Reaction Treatment Group Number of Patients (%) Bicalutamide Plus LHRH Analog (n=401) Flutamide Plus LHRH Analog (n=407) Body as a Whole Pain (General) 142 (35) 127 (31) Back Pain 102 (25) 105 (26) Asthenia 89 (22) 87 (21) Pelvic Pain 85 (21) 70 (17) Infection 71 (18) 57 (14) Abdominal Pain 46 (11) 46 (11) Chest Pain 34 (8) 34 (8) Headache 29 (7) 27 (7) Flu Syndrome 28 (7) 30 (7) Cardiovascular Hot Flashes 211 (53) 217 (53) Hypertension 34 (8) 29 (7) Digestive Constipation 87 (22) 69 (17) Nausea 62 (15) 58 (14) Diarrhea 49 (12) 107 (26) Increased Liver Enzyme Test 30 (7) 46 (11) Dyspepsia 30 (7) 23 (6) Flatulence 26 (6) 22 (5) Anorexia 25 (6) 29 (7) Vomiting 24 (6) 32 (8) Hemic and Lymphatic Anemia 45 (11) 53 (13) Metabolic and Nutritional Peripheral Edema 53 (13) 42 (10) Weight Loss 30 (7) 39 (10) Hyperglycemia 26 (6) 27 (7) Alkaline Phosphatase Increased 22 (5) 24 (6) Weight Gain 22 (5) 18 (4) Musculoskeletal Bone Pain 37 (9) 43 (11) Myasthenia 27 (7) 19 (5) Arthritis 21 (5) 29 (7) Pathological Fracture 17 (4) 32 (8) Nervous System Dizziness 41 (10) 35 (9) Paresthesia 31 (8) 40 (10) Insomnia 27 (7) 39 (10) Anxiety 20 (5) 9 (2) Depression 16 (4) 33 (8) Respiratory System Dyspnea 51 (13) 32 (8) Cough Increased 33 (8) 24 (6) Pharyngitis 32 (8) 23 (6) Bronchitis 24 (6) 22 (3) Pneumonia 18 (4) 19 (5) Rhinitis 15 (4) 22 (5) Skin and Appendages Rash 35 (9) 30 (7) Sweating 25 (6) 20 (5) Urogenital Nocturia 49 (12) 55 (14) Hematuria 48 (12) 26 (6) Urinary Tract Infection 35 (9) 36 (9) Gynecomastia 36 (9) 30 (7) Impotence 27 (7) 35 (9) Breast Pain 23 (6) 15 (4) Urinary Frequency 23 (6) 29 (7) Urinary Retention 20 (5) 14 (3) Urinary Impaired 19 (5) 15 (4) Urinary Incontinence 15 (4) 32 (8) Other adverse reactions (greater than or equal to 2%, but less than 5%) reported in the bicalutamide-LHRH analog treatment group are listed below by body system and are in order of decreasing frequency within each body system regardless of causality. Body as a Whole: Neoplasm; Neck Pain; Fever; Chills; Sepsis; Hernia; Cyst Cardiovascular: Angina Pectoris; Congestive Heart Failure; Myocardial Infarct; Heart Arrest; Coronary Artery Disorder; Syncope Digestive: Melena; Rectal Hemorrhage; Dry Mouth; Dysphagia; Gastrointestinal Disorder; Periodontal Abscess; Gastrointestinal Carcinoma Metabolic and Nutritional: Edema; BUN Increased; Creatinine Increased; Dehydration; Gout; Hypercholesteremia Musculoskeletal: Myalgia; Leg Cramps Nervous: Hypertonia; Confusion; Somnolence; Libido Decreased; Neuropathy; Nervousness Respiratory: Lung Disorder; Asthma; Epistaxis; Sinusitis Skin and Appendages: Dry Skin; Alopecia; Pruritus; Herpes Zoster; Skin Carcinoma; Skin Disorder Special Senses: Cataract Specified Urogenital: Dysuria; Urinary Urgency; Hydronephrosis; Urinary Tract Disorder Abnormal Laboratory Test Values: Laboratory abnormalities including: elevated AST, ALT, bilirubin, BUN, and creatinine; and decreased hemoglobin and white cell count, have been reported in both bicalutamide-LHRH analog treated and flutamide-LHRH analog treated patients. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of bicalutamide. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Respiratory disorders: Interstitial lung disease (some fatal) including interstitial pneumonitis and pulmonary fibrosis, most often at doses greater than 50 mg. Hemorrhage: Increased PT/INR due to interaction between coumarin anticoagulants and bicalutamide. Serious bleeding reported. [see Warnings and Precautions (5.2)] Skin and subcutaneous tissue disorders: Photosensitivity"],"contraindications":["4 CONTRAINDICATIONS Bicalutamide is contraindicated in: • Hypersensitivity Bicalutamide is contraindicated in any patient who has shown a hypersensitivity reaction to the drug or any of the tablet’s components. Hypersensitivity reactions including angioneurotic edema and urticaria have been reported. • Women Bicalutamide has no indication for women, and should not be used in this population. • Pregnancy Bicalutamide can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)]. • Hypersensitivity ( 4 ) • Women ( 4 ) • Pregnancy ( 4, 8.1 )"],"drug_interactions":["7 DRUG INTERACTIONS Clinical studies have not shown any drug interactions between bicalutamide and LHRH analogs (goserelin or leuprolide). There is no evidence that bicalutamide induces hepatic enzymes. In vitro studies have shown that R-bicalutamide is an inhibitor of CYP 3A4 with lesser inhibitory effects on CYP 2C9, 2C19 and 2D6 activity. Clinical studies have shown that with coadministration of bicalutamide, mean midazolam (a CYP 3A4 substrate) levels may be increased 1.5-fold (for C max ) and 1.9-fold (for AUC). Hence, caution should be exercised when bicalutamide is coadministered with CYP 3A4 substrates. In vitro protein-binding studies have shown that bicalutamide can displace coumarin anticoagulants from binding sites. PT/INR should be closely monitored in patients concomitantly receiving coumarin anticoagulants and bicalutamide. Adjustment of the anticoagulant dose may be necessary [see Warnings and Precautions (5.2) and Adverse Reactions (6.2)]. • R-bicalutamide is an inhibitor of CYP 3A4; therefore, caution should be used when bicalutamide is coadministered with CYP 3A4 substrates. (7) • PT/INR should be closely monitored in patients already receiving coumarin anticoagulants who are started on bicalutamide. (7)"],"labor_and_delivery":["8.2 Lactation Risk Summary Bicalutamide is not indicated for use in pregnant women. There is no information available on the presence of bicalutamide in human milk, or on the effects on the breastfed infant or on milk production. Bicalutamide has been detected in rat milk."],"mechanism_of_action":["12.1 Mechanism of Action Bicalutamide is a non-steroidal androgen receptor inhibitor. It competitively inhibits the action of androgens by binding to cytosol androgen receptors in the target tissue. Prostatic carcinoma is known to be androgen sensitive and responds to treatment that counteracts the effect of androgen and/or removes the source of androgen. When bicalutamide is combined with LHRH analog therapy, the suppression of serum testosterone induced by the LHRH analog is not affected. However, in clinical trials with bicalutamide as a single agent for prostate cancer, rises in serum testosterone and estradiol have been noted. In a subset of patients who have been treated with bicalutamide and an LHRH agonist, and who discontinue bicalutamide therapy due to progressive advanced prostate cancer, a reduction in Prostate Specific Antigen (PSA) and/or clinical improvement (antiandrogen withdrawal phenomenon) may be observed."],"pediatric_use_table":["
Table 2. Growth Rates
Endpoint Analysis PopulationPre-study Mean Change from pre-study to 12 months% patients with growth reductionChange compared to pre-study growth rate.
Mean Median (Min, Max)
Growth rate (cm/yr) All treated (n=13) 10.8 -1.6 -2.8 (-7.4, 8.4) 9/13 (69%)
PTPT = Previous treatment for testotoxicosis with ketoconazole, spironolactone, anastrozole or other aromatase inhibitors. (n=6) 10.3 -0.2 -2.6Median calculated as midpoint of 3rd and 4th ranked observations. (-7.2, 8.4) 4/6 (67%)
NPTNPT = no previous treatment for testotoxicosis with ketoconazole, spironolactone, anastrozole, or other aromatase inhibitors. (n=7) 11.2 -2.8 -2.8 (-7.4, 1.1) 5/7 (71%)
Growth rate (SD units) All treated (n=13) 0.4 -0.1 -0.4 (-2.7, 3.5) 9/13 (69%)
PT (n=6) -0.1 +0.7 -0.2 (-1.6, 3.5) 4/6 (67%)
NPT (n=7) 0.8 -0.7 -0.4 (-2.7, 0.5) 5/7 (71%)
"],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Bicalutamide is a non-steroidal androgen receptor inhibitor. It competitively inhibits the action of androgens by binding to cytosol androgen receptors in the target tissue. Prostatic carcinoma is known to be androgen sensitive and responds to treatment that counteracts the effect of androgen and/or removes the source of androgen. When bicalutamide is combined with LHRH analog therapy, the suppression of serum testosterone induced by the LHRH analog is not affected. However, in clinical trials with bicalutamide as a single agent for prostate cancer, rises in serum testosterone and estradiol have been noted. In a subset of patients who have been treated with bicalutamide and an LHRH agonist, and who discontinue bicalutamide therapy due to progressive advanced prostate cancer, a reduction in Prostate Specific Antigen (PSA) and/or clinical improvement (antiandrogen withdrawal phenomenon) may be observed. 12.3 Pharmacokinetics Absorption Bicalutamide is well-absorbed following oral administration, although the absolute bioavailability is unknown. Coadministration of bicalutamide with food has no clinically significant effect on rate or extent of absorption. Distribution Bicalutamide is highly protein-bound (96%) [see Drug Interactions (7)]. Metabolism/Elimination Bicalutamide undergoes stereospecific metabolism. The S (inactive) isomer is metabolized primarily by glucuronidation. The R (active) isomer also undergoes glucuronidation but is predominantly oxidized to an inactive metabolite followed by glucuronidation. Both the parent and metabolite glucuronides are eliminated in the urine and feces. The S-enantiomer is rapidly cleared relative to the R-enantiomer, with the R-enantiomer accounting for about 99% of total steady-state plasma levels. Pharmacokinetics of the active enantiomer of bicalutamide in normal males and patients with prostate cancer are presented in Table 3. Table 3. Pharmacokinetics of Bicalutamide Active Enantiomer Parameter Mean Standard Deviation Normal Males (n=30) Apparent Oral Clearance (L/hr) 0.320 0.103 Single Dose Peak Concentration (mcg/mL) 0.768 0.178 Single Dose Time to Peak Concentration (hours) 31.3 14.6 Half-life (days) 5.8 2.29 Patients with Prostate Cancer (n=40) C ss (mcg/mL) 8.939 3.504"],"indications_and_usage":["1 INDICATIONS AND USAGE Bicalutamide tablets, USP 50 mg daily are indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate. Bicalutamide tablets, USP 150 mg daily are not approved for use alone or with other treatments [see Clinical Studies (14.2)]. • Bicalutamide tablet 50 mg is an androgen receptor inhibitor indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate. (1) • Bicalutamide tablet 150 mg daily is not approved for use alone or with other treatments. (1)"],"warnings_and_cautions":["5 WARNINGS AND PRECAUTIONS • Severe hepatic injury and fatal hepatic failure have been observed. Monitor serum transaminase levels prior to starting treatment with bicalutamide, at regular intervals for the first four months of treatment and periodically thereafter, and for symptoms or signs suggestive of hepatic dysfunction. Use bicalutamide with caution in patients with hepatic impairment. ( 5.1 ) • Hemorrhage with Concomitant Use of Coumarin Anticoagulant. Closely monitor the Prothrombin Time (PT) and International Normalized Ratio (INR), and adjust the anticoagulant dose as needed. ( 5.2 ) • Gynecomastia and breast pain have been reported during treatment with bicalutamide 150 mg when used as a single agent. ( 5.3 ) • Bicalutamide is used in combination with an LHRH agonist. LHRH agonists have been shown to cause a reduction in glucose tolerance in males. Consideration should be given to monitoring blood glucose in patients receiving bicalutamide in combination with LHRH agonists. ( 5.4 ) • Monitoring Prostate Specific Antigen (PSA) is recommended. Evaluate for clinical progression if PSA increases. ( 5.5 ) 5.1 Hepatitis Cases of death or hospitalization due to severe liver injury (hepatic failure) have been reported postmarketing in association with the use of bicalutamide. Hepatotoxicity in these reports generally occurred within the first three to four months of treatment. Hepatitis or marked increases in liver enzymes leading to drug discontinuation occurred in approximately 1% of bicalutamide patients in controlled clinical trials. Serum transaminase levels should be measured prior to starting treatment with bicalutamide, at regular intervals for the first four months of treatment, and periodically thereafter. If clinical symptoms or signs suggestive of liver dysfunction occur (e.g., nausea, vomiting, abdominal pain, fatigue, anorexia, “flu-like” symptoms, dark urine, jaundice, or right upper quadrant tenderness), the serum transaminases, in particular the serum ALT, should be measured immediately. If at any time a patient has jaundice, or their ALT rises above two times the upper limit of normal, bicalutamide should be immediately discontinued with close follow-up of liver function. 5.2 Hemorrhage with Concomitant Use of Coumarin Anticoagulant In the postmarketing setting, there have been reports of excessive prolongation of the prothrombin time (PT) and International Normalized Ratio (INR) days to weeks after the introduction of bicalutamide in patients who were previously stable on coumarin anticoagulants. Some patients had serious bleeding including intracranial, retroperitoneal, and gastrointestinal requiring blood transfusion and/or administration of vitamin K. Closely monitor the PT/INR, and adjust the anticoagulant dose as needed [see Drug Interactions (7) and Adverse Reactions (6.2)]. 5.3 Gynecomastia and Breast Pain In clinical trials with bicalutamide 150 mg as a single agent for prostate cancer, gynecomastia and breast pain have been reported in up to 38% and 39% of patients, respectively. 5.4 Glucose Tolerance A reduction in glucose tolerance has been observed in males receiving LHRH agonists. This may manifest as diabetes or loss of glycemic control in those with preexisting diabetes. Consideration should therefore be given to monitoring blood glucose in patients receiving bicalutamide in combination with LHRH agonists. 5.5 Laboratory Tests Regular assessments of serum Prostate Specific Antigen (PSA) may be helpful in monitoring the patient’s response. If PSA levels rise during bicalutamide therapy, the patient should be evaluated for clinical progression. For patients who have objective progression of disease together with an elevated PSA, a treatment-free period of antiandrogen, while continuing the LHRH analog, may be considered."],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Two-year oral carcinogenicity studies were conducted in both male and female rats and mice at doses of 5, 15, or 75 mg/kg/day of bicalutamide. A variety of tumor target organ effects were identified and were attributed to the antiandrogenicity of bicalutamide, namely, testicular benign interstitial (Leydig) cell tumors in male rats at all dose levels (the steady-state plasma concentration with the 5 mg/kg/day dose is approximately 0.7 times the human exposure at the recommended dose) and uterine adenocarcinoma in female rats at 75 mg/kg/day (approximately 1.5 times the human exposure at the recommended dose). There is no evidence of Leydig cell hyperplasia in patients; uterine tumors are not relevant to the indicated patient population. A small increase in the incidence of hepatocellular carcinoma in male mice given 75 mg/kg/day of bicalutamide (approximately 4 times the human exposure at the recommended dose) and an increased incidence of benign thyroid follicular cell adenomas in rats given 5 mg/kg/day (approximately 0.7 times the human exposure at the recommended dose) and above were recorded. These neoplastic changes were progressions of non-neoplastic changes related to hepatic enzyme induction observed in animal toxicity studies. Enzyme induction has not been observed following bicalutamide administration in man. There were no tumorigenic effects suggestive of genotoxic carcinogenesis. A comprehensive battery of both in vitro and in vivo genotoxicity tests (yeast gene conversion, Ames, E. coli , CHO/HGPRT, human lymphocyte cytogenetic, mouse micronucleus, and rat bone marrow cytogenetic tests) has demonstrated that bicalutamide does not have genotoxic activity. In repeat-dose toxicology studies, atrophy of seminiferous tubules of the testes has been observed for all species examined, which is a predicted class effect with antiandrogens. In the 6- and 12-month rat study, testicular atrophy was seen at approximately 2 times the human exposure at the recommended dose. In the 12-month dog study, the incidence of testicular atrophy was seen at approximately 7 times the human exposure at the recommended dose. In male rats administered 250 mg/kg/day (approximately 2 times human exposure at the recommended dose), the precoital interval and time to successful mating were increased in the first pairing, but no effects on fertility following successful mating were seen. These effects were reversed by 7 weeks after the end of an 11-week period of dosing. Female rats dosed at 1, 10 and 250 mg/kg/day (less than to 2 times the human exposure at the recommended dose) had increased estrous cycle irregularity but there was no effect on fertility. In a peri- and post-natal development study, female offspring of rats receiving doses of 10 mg/kg/day (approximately 0.7 times the human exposure at the recommended clinical dose) and above had reduced pregnancy rates. Administration of bicalutamide to pregnant females resulted in feminization of the male offspring leading to hypospadias at doses of 10 mg/kg/day (approximately 0.7 times the human exposure at the recommended dose) and above. Affected male offspring were also impotent."],"pharmacokinetics_table":["
Table 3. Pharmacokinetics of Bicalutamide Active Enantiomer
Parameter Mean Standard Deviation
Normal Males (n=30)
Apparent Oral Clearance (L/hr) 0.3200.103
Single Dose Peak Concentration (mcg/mL) 0.768 0.178
Single Dose Time to Peak Concentration (hours) 31.3 14.6
Half-life (days) 5.8 2.29
Patients with Prostate Cancer (n=40)
Css (mcg/mL) 8.939 3.504
"],"adverse_reactions_table":["
Table 1 Incidence of Adverse Reactions (≥ 5% in Either Treatment Group) Regardless of Causality
Body System Adverse Reaction Treatment Group Number of Patients (%)
Bicalutamide Plus LHRH Analog (n=401) Flutamide Plus LHRH Analog (n=407)
Body as a Whole
Pain (General) 142 (35) 127 (31)
Back Pain 102 (25) 105 (26)
Asthenia 89 (22) 87 (21)
Pelvic Pain 85 (21) 70 (17)
Infection 71 (18) 57 (14)
Abdominal Pain 46 (11) 46 (11)
Chest Pain 34 (8) 34 (8)
Headache 29 (7) 27 (7)
Flu Syndrome 28 (7) 30 (7)
Cardiovascular
Hot Flashes 211 (53) 217 (53)
Hypertension 34 (8) 29 (7)
Digestive
Constipation 87 (22) 69 (17)
Nausea 62 (15) 58 (14)
Diarrhea 49 (12) 107 (26)
Increased Liver Enzyme Test 30 (7) 46 (11)
Dyspepsia 30 (7) 23 (6)
Flatulence 26 (6) 22 (5)
Anorexia 25 (6) 29 (7)
Vomiting 24 (6) 32 (8)
Hemic and Lymphatic
Anemia 45 (11) 53 (13)
Metabolic and Nutritional
Peripheral Edema 53 (13) 42 (10)
Weight Loss 30 (7) 39 (10)
Hyperglycemia 26 (6) 27 (7)
Alkaline Phosphatase Increased 22 (5) 24 (6)
Weight Gain 22 (5) 18 (4)
Musculoskeletal
Bone Pain 37 (9) 43 (11)
Myasthenia 27 (7) 19 (5)
Arthritis 21 (5) 29 (7)
Pathological Fracture 17 (4) 32 (8)
Nervous System
Dizziness 41 (10) 35 (9)
Paresthesia 31 (8) 40 (10)
Insomnia 27 (7) 39 (10)
Anxiety 20 (5) 9 (2)
Depression 16 (4) 33 (8)
Respiratory System
Dyspnea 51 (13) 32 (8)
Cough Increased 33 (8) 24 (6)
Pharyngitis 32 (8) 23 (6)
Bronchitis 24 (6) 22 (3)
Pneumonia 18 (4) 19 (5)
Rhinitis 15 (4) 22 (5)
Skin and Appendages
Rash 35 (9) 30 (7)
Sweating 25 (6) 20 (5)
Urogenital
Nocturia 49 (12) 55 (14)
Hematuria 48 (12) 26 (6)
Urinary Tract Infection 35 (9) 36 (9)
Gynecomastia 36 (9) 30 (7)
Impotence 27 (7) 35 (9)
Breast Pain 23 (6) 15 (4)
Urinary Frequency 23 (6) 29 (7)
Urinary Retention 20 (5) 14 (3)
Urinary Impaired 19 (5) 15 (4)
Urinary Incontinence 15 (4) 32 (8)
"],"information_for_patients":["17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Dose and Schedule: Inform patients that therapy with bicalutamide and the LHRH analog should be started at the same time and that they should not interrupt or stop taking these medications without consulting their healthcare provider [see Dosage and Administration (2.1)]. Hepatitis: Inform patients that bicalutamide can cause hepatitis, which may result in hepatic failure and death. Advise patients that liver function tests should be monitored regularly during treatment and to report signs and symptoms of hepatitis [see Warnings and Precautions (5.1)]. Hemorrhage with Concomitant Use of Coumarin Anticoagulant: Inform patients that serious bleeding has occurred with reported increased anticoagulant effects while taking bicalutamide. Advise patients to notify their healthcare provider of any bleeding or spontaneous bruising while on bicalutamide and taking anticoagulants [see Warnings and Precautions (5.2) and Adverse Reactions (6.2)]. Glucose Tolerance: Inform patients that diabetes or loss of glycemic control in patients with preexisting diabetes has been reported during treatment with LHRH agonists. Consideration should therefore be given to monitoring blood glucose in patients receiving bicalutamide in combination with LHRH agonists [see Warnings and Precautions (5.4)]. Somnolence: During treatment with bicalutamide, somnolence has been reported. Advise patients who experience this symptom to observe caution when driving or operating machines [see Adverse Reactions (6.1)]. Photosensitivity: Inform patients that cases of photosensitivity have been reported during treatment with bicalutamide and that they should avoid direct exposure to excessive sunlight or UV-light exposure. Consideration should be given to the use of sunscreen [see Adverse Reactions (6.2)]. Contraception and fertility: Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 130 days after the last dose of bicalutamide therapy. Advise male patients that bicalutamide may impair fertility [see Use in Specific Populations (8.3)]. Dispense with Patient Information available at: https://www.sunpharma.com/usa/products"],"dosage_and_administration":["2 DOSAGE AND ADMINISTRATION The recommended dose for bicalutamide tablets therapy in combination with an LHRH analog is one 50 mg tablet once daily (morning or evening). (2) 2.1 Recommended Dose and Schedule The recommended dose for bicalutamide tablets therapy in combination with an LHRH analog is one 50 mg tablet once daily (morning or evening), with or without food. It is recommended that bicalutamide tablets be taken at the same time each day. Treatment with bicalutamide tablets should be started at the same time as treatment with an LHRH analog. If a dose of bicalutamide tablets is missed, take the next dose at the scheduled time. Do not take the missed dose and do not double the next dose. 2.2 Dosage Adjustment in Renal Impairment No dosage adjustment is necessary for patients with renal impairment [see Use in Specific Populations (8.7)]. 2.3 Dosage Adjustment in Hepatic Impairment No dosage adjustment is necessary for patients with mild to moderate hepatic impairment. In patients with severe liver impairment (n=4), although there was a 76% increase in the half-life (5.9 and 10.4 days for normal and impaired patients, respectively) of the active enantiomer of bicalutamide, no dosage adjustment is necessary [see Use in Specific Populations (8.6)]."],"spl_product_data_elements":["bicalutamide bicalutamide BICALUTAMIDE BICALUTAMIDE LACTOSE MONOHYDRATE SODIUM STARCH GLYCOLATE TYPE A POTATO POVIDONE, UNSPECIFIED MAGNESIUM STEARATE HYPROMELLOSE, UNSPECIFIED POLYETHYLENE GLYCOL, UNSPECIFIED TITANIUM DIOXIDE wite to off white 485"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS Bicalutamide 50 mg tablets for oral administration. 50 mg tablets (3)"],"spl_patient_package_insert":["Patient Information Bicalutamide (BYE-ka-LOO-ta-mide) Tablets, USP What are bicalutamide tablets? Bicalutamide tablets are prescription medicines called androgen receptor inhibitors, used in combination with luteinizing hormone-releasing hormone (LHRH) medicines to treat Stage D 2 metastatic prostate cancer. Bicalutamide tablet 150 mg daily is not approved for use alone or with other treatments. It is not known if bicalutamidetablets are safe and effective in children. Do not take bicalutamide tablets if you are: • allergic to bicalutamide or any of the ingredients in bicalutamide tablets. See the end of this Patient Information leaflet for a complete list of ingredients in bicalutamide tablets. Get medical help right away if you develop any of the following symptoms of an allergic reaction: o itching o hives (raised bumps) o swelling of the face, lips or tongue o trouble breathing or swallowing • female. Bicalutamide tablets are not for use by women. • pregnant or may become pregnant. Bicalutamide may harm your unborn baby. Before taking bicalutamide tablets, tell your healthcare provider about all your medical conditions, including if you: • have liver problems. • take a medicine to thin your blood. Ask your healthcare provider or pharmacist if you are not sure if your medicine is a blood thinner. • have diabetes. • have a female partner who can become pregnant. Males who have a female partner who can become pregnant should use effective birth control during treatment with bicalutamide tablets and for 130 days after the final dose. Talk to your healthcare provider if you have any questions about birth control. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Bicalutamide tablets may affect the way other medicines work and other medicines may affect how bicalutamide tablets work, causing side effects. Know the medicines you take. Keep a list of your medicines with you to show your healthcare providers when you get a new medicine. How should I take bicalutamide tablets? • Take bicalutamide tablets exactly as your healthcare provider tells you to take it. • Do not stop taking bicalutamide tablets unless your healthcare provider tells you to. • Bicalutamide tablets can be taken either in the morning or in the evening, but you should take it at the same time every day. • Your treatment with bicalutamide tablets should start at the same time as your treatment with the LHRH medicine. • If you miss a bicalutamide tablets dose do not take the missed dose, take the next dose at your next scheduled time. Do not take 2 doses at the same time. • Bicalutamide tablets can be taken with or without food. • If you take too much bicalutamide tablets, call your healthcare provider or go to the nearest hospital emergency room right away. What should I avoid during treatment with bicalutamide tablets? • Do not drive, operate machinery, or do other dangerous activities until you know how bicalutamide tablets affect you. Bicalutamide tablets can make you sleepy. • Avoid sunlight, sunlamps, and tanning beds, and consider using sunscreen during treatment with bicalutamide tablets. Some people have had skin sensitivity to sunlight during treatment with bicalutamide tablets. What are the possible side effects of bicalutamide tablets? Bicalutamide tablets may cause serious side effects, including: • Liver problems. Severe liver problems, including liver failure that may need to be treated in a hospital or that may lead to death have happened in people who take bicalutamide tablets. Your healthcare provider should do blood tests to check your liver function before and during treatment with bicalutamide tablets. Tell your healthcare provider right away if you develop any of these symptoms of liver problems during treatment: o yellowing of the skin and eyes (jaundice) o dark urine o right upper stomach pain o nausea o vomiting o tiredness o loss of appetite o chills o fever • Bleeding problems. Serious bleeding problems have happened in people who take bicalutamide tablets in combination with a blood thinner medicine (coumarin anticoagulants). Bleeding problems have happened days to weeks after starting bicalutamide tablets treatment. If you take a blood thinner medicine during treatment with bicalutamide tablets, tell your healthcare provider if you develop any bleeding or unexplained bruising. • Breast enlargement (gynecomastia) and breast pain . • Blood sugar problems . Poor blood sugar control can happen in people who take bicalutamide tablets in combination with LHRH medicines. Your healthcare provider may do blood tests during treatment with bicalutamide tablets to check for side effects. Your prostate cancer may get worse during treatment with bicalutamide tablets in combination with LHRH medicines. Regular monitoring of your prostate cancer with your healthcare provider is important to determine if your disease is worse. Tell your healthcare provider if you have trouble breathing with or without a cough or fever. Some people taking bicalutamide tablets get an inflammation in the lungs called interstitial lung disease. The most common side effects of bicalutamide tablets include: • hot flashes (short periods of feeling warm and sweating) • body pain (including back, pelvis, stomach) • feeling weak • constipation • infection • nausea • swelling in your arms, ankles, legs or feet • shortness of breath (dyspnea) • dizziness • diarrhea • blood in your urine • frequent urination at night • a decrease in red blood cells (anemia) Bicalutamide tablets may have an effect on male fertility which could be reversible. Talk to your healthcare provider if this is a concern for you. 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 bicalutamide tablets. For more information, ask your healthcare provider or pharmacist. 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 bicalutamide tablets? • Store bicalutamide tablets at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). • Bicalutamide tablets come in a child-resistant package. Keep bicalutamide tablets and all medicines out of the reach of children. General information about the safe and effective use of bicalutamide tablets. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use bicalutamide tablets for a condition for which it was not prescribed. Do not give bicalutamide tablets to other people, even if they have the same symptoms that you have. It may harm them. This Patient Information leaflet summarizes the most important information about bicalutamide tablets. If you would like more information about bicalutamide tablets, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about bicalutamide tablets that is written for health professionals. What are the ingredients in bicalutamide tablets? Active ingredient : bicalutamide Inactive ingredients : lactose monohydrate, sodium starch glycolate type A, povidone, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide For more information, call 1-800-818-4555. This Patient Information has been approved by the U.S. Food and Drug Administration. # All trademark names are the property of their respective owners. Dispense with Patient Information available at: https://www.sunpharma.com/usa/products Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 1012, Dadra-396 193, U.T. of D & NH and Daman & Diu, India. Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 ISS. 10/2023 5246064"],"clinical_pharmacology_table":["
Table 3. Pharmacokinetics of Bicalutamide Active Enantiomer
Parameter Mean Standard Deviation
Normal Males (n=30)
Apparent Oral Clearance (L/hr) 0.3200.103
Single Dose Peak Concentration (mcg/mL) 0.768 0.178
Single Dose Time to Peak Concentration (hours) 31.3 14.6
Half-life (days) 5.8 2.29
Patients with Prostate Cancer (n=40)
Css (mcg/mL) 8.939 3.504
"],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATIONS • Females and Males of Reproductive Potential: Advise males with female partners of reproductive potential to use effective contraception. ( 8.3 ) • Pediatric patients: Efficacy has not been demonstrated for the treatment of familial male-limited precocious puberty (testotoxicosis). ( 8.4 ) 8.1 Pregnancy Risk Summary Bicalutamide is contraindicated for use in pregnant women because it can cause fetal harm. Bicalutamide is not indicated for use in females. There are no human data on the use of bicalutamide in pregnant women. In animal reproduction studies, oral administration of bicalutamide to pregnant rats during organogenesis caused abnormal development of reproductive organs in male fetuses at exposures approximately 0.7 to 2 times the human exposure at the recommended dose (see Data). Data Animal Data In an embryo-fetal development study in pregnant rats dosed during the period of organogenesis from gestation days 6-15, male fetuses had reduced anogenital distance at doses of 10 mg/kg/day and above (approximately 0.7 to 2 times the human exposure at the recommended dose). In a pre- and post-natal development study, female rats were dosed from gestation day 7-16 and allowed to litter and rear their offspring to weaning. Male offspring of rats receiving doses of 10 mg/kg/day (approximately 0.7 times the human exposure at the recommended dose) and above, were observed to have reduced anogenital distance. In a peri- and post-natal development study, female rats were dosed from gestation day 16 to lactation day 22 and allowed to litter and rear their offspring to weaning. Survival and weights of offspring during lactation were reduced for litters from maternal rats receiving doses of 250 mg/kg/day (approximately 2 times the human exposure at the recommended dose). Male offspring of rats receiving doses of 10 mg/kg/day (approximately 0.7 times the human exposure at the recommended dose) and above, were observed to have reduced anogenital distance, smaller secondary sex organs, cryptorchidism and hypospadias resulting in an inability to mate and impregnate their female partners. Female offspring of rats receiving doses of 10 mg/kg/day (approximately 0.7 times the human exposure at the recommended dose) and above had reduced pregnancy rates. 8.2 Lactation Risk Summary Bicalutamide is not indicated for use in pregnant women. There is no information available on the presence of bicalutamide in human milk, or on the effects on the breastfed infant or on milk production. Bicalutamide has been detected in rat milk. 8.3 Females and Males of Reproductive Potential Contraception Males Antiandrogen therapy may cause morphological changes in spermatozoa [see Nonclinical Toxicology (13.1)]. Based on findings in animal reproduction studies and its mechanism of action, advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 130 days after the final dose of bicalutamide [see Use in Specific Populations (8.1) and Clinical Pharmacology (12.1)]. Infertility Males Based on animal studies, bicalutamide can lead to inhibition of spermatogenesis and may impair fertility in males of reproductive potential. The long-term effects of bicalutamide on male fertility have not been studied [see Nonclinical Toxicology (13.1)] . 8.4 Pediatric Use The safety and effectiveness of bicalutamide in pediatric patients have not been established. Bicalutamide orodispersible tablet was studied in combination with Arimidex # (anastrozole) orodispersible tablet in an open-label, non-comparative, multi-center study that assessed the efficacy and safety of this combination regimen over 12 months in the treatment of gonadotropin-independent precocious puberty in boys with familial male-limited precocious puberty, also known as testotoxicosis. Patients were enrolled in the study if they had a baseline age ≥2 years and a diagnosis of testotoxicosis based on clinical features of progressive precocious puberty, symmetrical testicular enlargement, advanced bone age, pubertal levels of serum testosterone, prepubertal pattern of gonadotropin secretion following a GnRH stimulation test, and absence of other clinical and biochemical causes of testosterone excess. Thirteen out of the 14 patients enrolled completed 12 months of combination treatment (one patient was lost to follow-up). If central precocious puberty (CPP) developed, an LHRH analog was to be added. Four patients were diagnosed with CPP during the 12-month study and received LHRH analog treatment and 2 additional patients were diagnosed at the end of the 12 months and received treatment subsequently. Mean ± SD characteristics at baseline were as follows: chronological age: 3.9±1.9 years; bone age 8.8±2.5; bone age/chronological age ratio: 2.06±0.51; growth rate (cm/yr): 10.81±4.22; growth rate standard deviation score (SDS): 0.41±1.36. The starting bicalutamide dose was 12.5 mg. Bicalutamide was titrated in each patient until steady-state R-bicalutamide (the active isomer of bicalutamide) trough plasma concentration reached 5 mcg/mL to 15 mcg/mL, which is the range of therapeutic concentrations achieved in adults with prostate cancer following the administration of the currently approved bicalutamide dose of 50 mg. The starting daily dose of anastrozole was 0.5 mg. Anastrozole was independently titrated in each patient until it reached at steady-state a serum estradiol concentration of <10 pmol/L (2.7 pg/mL). The following ascending doses were used for bicalutamide: 12.5 mg, 25 mg, 50 mg, and 100 mg. For anastrozole there were two ascending doses: 0.5 mg and 1 mg. At the end of the titration phase, 1 patient was on 12.5 mg bicalutamide, 8 patients were on 50 mg bicalutamide, and 4 patients were on 100 mg bicalutamide; 10 patients were on 0.5 mg anastrozole and 3 patients were on 1 mg anastrozole. In the majority of patients, steady-state trough concentrations of R-bicalutamide appeared to be attained by Day 21 with once daily dosing. Steady-state trough plasma anastrozole concentrations appeared to be attained by Day 8. The primary efficacy analysis of the study was to assess the change in growth rate after 12 months of treatment, relative to the growth rate during the ≥6 months prior to entering the study. Pre-study growth rates were obtained retrospectively. There was no statistical evidence that the growth rate was reduced during treatment. During bicalutamide / Arimidex # treatment the mean growth rate (cm/yr) decreased by 1.6 cm/year, 95% CI (-4.7 to 1.5) p=0.28; the mean growth rate SDS decreased by 0.1 SD, 95% CI (–1.2 to 1.0) p=0.88. Table 2 shows descriptive data for growth rates for the overall population and for subgroups defined by history of previous treatment for testotoxicosis with ketoconazole, spironolactone, anastrozole or other aromatase inhibitors. Table 2. Growth Rates Endpoint Analysis Population Pre-study Mean Change from pre-study to 12 months % patients with growth reduction Change compared to pre-study growth rate. Mean Median (Min, Max) Growth rate (cm/yr) All treated (n=13) 10.8 -1.6 -2.8 (-7.4, 8.4) 9/13 (69%) PT PT = Previous treatment for testotoxicosis with ketoconazole, spironolactone, anastrozole or other aromatase inhibitors. (n=6) 10.3 -0.2 -2.6 Median calculated as midpoint of 3rd and 4th ranked observations. (-7.2, 8.4) 4/6 (67%) NPT NPT = no previous treatment for testotoxicosis with ketoconazole, spironolactone, anastrozole, or other aromatase inhibitors. (n=7) 11.2 -2.8 -2.8 (-7.4, 1.1) 5/7 (71%) Growth rate (SD units) All treated (n=13) 0.4 -0.1 -0.4 (-2.7, 3.5) 9/13 (69%) PT (n=6) -0.1 +0.7 -0.2 (-1.6, 3.5) 4/6 (67%) NPT (n=7) 0.8 -0.7 -0.4 (-2.7, 0.5) 5/7 (71%) Total testosterone concentrations increased by a mean of 5 mmol/L over the 12 months of treatment from a baseline mean of 10 mmol/L. Estradiol concentrations were at or below the level of quantification (9.81 pmol/L) for 11 of 12 patients after 12 months of treatment. Six of the 12 patients started treatment at an estradiol concentration below the level of quantification. There were no deaths, serious adverse events, or discontinuations due to adverse events during the study. Of the 14 patients exposed to study treatment, 13 (92.9%) experienced at least one adverse event. The most frequently reported (>3 patients) adverse events were gynecomastia (7/14, 50%), central precocious puberty (6/14, 43%), vomiting (5/14, 36%), headache (3/14, 21%), pyrexia (3/14, 21%), and upper respiratory tract infection (3/14, 21%). Adverse reactions considered possibly related to bicalutamide by investigators included gynecomastia (6/14, 43%), central precocious puberty (2/14, 14%), breast tenderness (2/14, 14%), breast pain (1/14, 7%), asthenia (1/14, 7%), increased alanine aminotransferase [ALT] (1/14, 7%), increased aspartate aminotransferase [AST] (1/14, 7%), and musculoskeletal chest pain (1/14, 7%). Headache was the only adverse reaction considered possibly related to anastrozole by investigators. For the patient who developed elevated ALT and AST, the elevation was <3X ULN, and returned to normal without stopping treatment; there was no concomitant elevation in total bilirubin. 8.5 Geriatric Use In two studies in patients given 50 mg or 150 mg daily, no significant relationship between age and steady-state levels of total bicalutamide or the active R-enantiomer has been shown. 8.6 Hepatic Impairment Bicalutamide should be used with caution in patients with moderate-to-severe hepatic impairment. Bicalutamide is extensively metabolized by the liver. Limited data in subjects with severe hepatic impairment suggest that excretion of bicalutamide may be delayed and could lead to further accumulation. Periodic liver function tests should be considered for hepatic-impaired patients on long-term therapy [see Warnings and Precautions (5.1)]. No clinically significant difference in the pharmacokinetics of either enantiomer of bicalutamide was noted in patients with mild-to-moderate hepatic disease as compared to healthy controls. However, the half-life of the R-enantiomer was increased approximately 76% (5.9 and 10.4 days for normal and impaired patients, respectively) in patients with severe liver disease (n=4). 8.7 Renal Impairment Renal impairment (as measured by creatinine clearance) had no significant effect on the elimination of total bicalutamide or the active R-enantiomer."],"use_in_specific_populations_table":["
Table 2. Growth Rates
Endpoint Analysis PopulationPre-study Mean Change from pre-study to 12 months% patients with growth reductionChange compared to pre-study growth rate.
Mean Median (Min, Max)
Growth rate (cm/yr) All treated (n=13) 10.8 -1.6 -2.8 (-7.4, 8.4) 9/13 (69%)
PTPT = Previous treatment for testotoxicosis with ketoconazole, spironolactone, anastrozole or other aromatase inhibitors. (n=6) 10.3 -0.2 -2.6Median calculated as midpoint of 3rd and 4th ranked observations. (-7.2, 8.4) 4/6 (67%)
NPTNPT = no previous treatment for testotoxicosis with ketoconazole, spironolactone, anastrozole, or other aromatase inhibitors. (n=7) 11.2 -2.8 -2.8 (-7.4, 1.1) 5/7 (71%)
Growth rate (SD units) All treated (n=13) 0.4 -0.1 -0.4 (-2.7, 3.5) 9/13 (69%)
PT (n=6) -0.1 +0.7 -0.2 (-1.6, 3.5) 4/6 (67%)
NPT (n=7) 0.8 -0.7 -0.4 (-2.7, 0.5) 5/7 (71%)
"],"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 82804-082-90 Bicalutamide Tablets, USP 50 mg Pharmacist: Dispense with Patient Information Leaflet Rx only 90 Tablets 82804-082-90"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Two-year oral carcinogenicity studies were conducted in both male and female rats and mice at doses of 5, 15, or 75 mg/kg/day of bicalutamide. A variety of tumor target organ effects were identified and were attributed to the antiandrogenicity of bicalutamide, namely, testicular benign interstitial (Leydig) cell tumors in male rats at all dose levels (the steady-state plasma concentration with the 5 mg/kg/day dose is approximately 0.7 times the human exposure at the recommended dose) and uterine adenocarcinoma in female rats at 75 mg/kg/day (approximately 1.5 times the human exposure at the recommended dose). There is no evidence of Leydig cell hyperplasia in patients; uterine tumors are not relevant to the indicated patient population. A small increase in the incidence of hepatocellular carcinoma in male mice given 75 mg/kg/day of bicalutamide (approximately 4 times the human exposure at the recommended dose) and an increased incidence of benign thyroid follicular cell adenomas in rats given 5 mg/kg/day (approximately 0.7 times the human exposure at the recommended dose) and above were recorded. These neoplastic changes were progressions of non-neoplastic changes related to hepatic enzyme induction observed in animal toxicity studies. Enzyme induction has not been observed following bicalutamide administration in man. There were no tumorigenic effects suggestive of genotoxic carcinogenesis. A comprehensive battery of both in vitro and in vivo genotoxicity tests (yeast gene conversion, Ames, E. coli , CHO/HGPRT, human lymphocyte cytogenetic, mouse micronucleus, and rat bone marrow cytogenetic tests) has demonstrated that bicalutamide does not have genotoxic activity. In repeat-dose toxicology studies, atrophy of seminiferous tubules of the testes has been observed for all species examined, which is a predicted class effect with antiandrogens. In the 6- and 12-month rat study, testicular atrophy was seen at approximately 2 times the human exposure at the recommended dose. In the 12-month dog study, the incidence of testicular atrophy was seen at approximately 7 times the human exposure at the recommended dose. In male rats administered 250 mg/kg/day (approximately 2 times human exposure at the recommended dose), the precoital interval and time to successful mating were increased in the first pairing, but no effects on fertility following successful mating were seen. These effects were reversed by 7 weeks after the end of an 11-week period of dosing. Female rats dosed at 1, 10 and 250 mg/kg/day (less than to 2 times the human exposure at the recommended dose) had increased estrous cycle irregularity but there was no effect on fertility. In a peri- and post-natal development study, female offspring of rats receiving doses of 10 mg/kg/day (approximately 0.7 times the human exposure at the recommended clinical dose) and above had reduced pregnancy rates. Administration of bicalutamide to pregnant females resulted in feminization of the male offspring leading to hypospadias at doses of 10 mg/kg/day (approximately 0.7 times the human exposure at the recommended dose) and above. Affected male offspring were also impotent."]},"tags":[{"label":"Androgen Receptor Inhibitor","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Androgen receptor","category":"target"},{"label":"AR","category":"gene"},{"label":"CYP2C19","category":"gene"},{"label":"L02AE51","category":"atc"},{"label":"Oral","category":"route"},{"label":"Tablet","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Metastatic Prostate Carcinoma","category":"indication"},{"label":"Ani Pharms","category":"company"},{"label":"Approved 1990s","category":"decade"},{"label":"Androgen Antagonists","category":"pharmacology"},{"label":"Antineoplastic Agents","category":"pharmacology"},{"label":"Hormone Antagonists","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"1301 reports"},{"date":"","signal":"DEATH","source":"FDA FAERS","actionTaken":"972 reports"},{"date":"","signal":"PROSTATIC SPECIFIC ANTIGEN INCREASED","source":"FDA FAERS","actionTaken":"923 reports"},{"date":"","signal":"ASTHENIA","source":"FDA FAERS","actionTaken":"794 reports"},{"date":"","signal":"HOT FLUSH","source":"FDA FAERS","actionTaken":"776 reports"},{"date":"","signal":"PROSTATE CANCER","source":"FDA FAERS","actionTaken":"742 reports"},{"date":"","signal":"MALIGNANT NEOPLASM PROGRESSION","source":"FDA FAERS","actionTaken":"706 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"598 reports"},{"date":"","signal":"DIZZINESS","source":"FDA FAERS","actionTaken":"574 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"556 reports"}],"commonSideEffects":[{"effect":"Pain (General)","drugRate":"35%","severity":"serious","_validated":true},{"effect":"Back Pain","drugRate":"25%","severity":"serious","_validated":true},{"effect":"Asthenia","drugRate":"22%","severity":"serious","_validated":true},{"effect":"Pelvic Pain","drugRate":"21%","severity":"serious","_validated":true},{"effect":"Infection","drugRate":"18%","severity":"serious","_validated":true},{"effect":"Abdominal Pain","drugRate":"11%","severity":"common","_validated":true},{"effect":"Chest Pain","drugRate":"8%","severity":"common","_validated":true},{"effect":"Headache","drugRate":"7%","severity":"common","_validated":true},{"effect":"Flu Syndrome","drugRate":"7%","severity":"common","_validated":true},{"effect":"Hot Flashes","drugRate":"53%","severity":"serious","_validated":true},{"effect":"Hypertension","drugRate":"8%","severity":"common","_validated":true},{"effect":"Constipation","drugRate":"22%","severity":"serious","_validated":true},{"effect":"Nausea","drugRate":"15%","severity":"common","_validated":true},{"effect":"Diarrhea","drugRate":"26%","severity":"serious","_validated":true},{"effect":"Increased Liver Enzyme Test","drugRate":"7%","severity":"common","_validated":true},{"effect":"Dyspepsia","drugRate":"7%","severity":"common","_validated":true},{"effect":"Flatulence","drugRate":"6%","severity":"mild","_validated":true},{"effect":"Anorexia","drugRate":"6%","severity":"mild","_validated":true},{"effect":"Vomiting","drugRate":"6%","severity":"mild","_validated":true},{"effect":"Anemia","drugRate":"11%","severity":"serious","_validated":true},{"effect":"Peripheral Edema","drugRate":"13%","severity":"serious","_validated":true},{"effect":"Weight Loss","drugRate":"7%","severity":"common","_validated":true},{"effect":"Hyperglycemia","drugRate":"6%","severity":"mild","_validated":true},{"effect":"Bone Pain","drugRate":"9%","severity":"common","_validated":true},{"effect":"Dizziness","drugRate":"10%","severity":"serious","_validated":true},{"effect":"Paresthesia","drugRate":"8%","severity":"common","_validated":true},{"effect":"Insomnia","drugRate":"10%","severity":"serious","_validated":true},{"effect":"Dyspnea","drugRate":"13%","severity":"serious","_validated":true},{"effect":"Cough Increased","drugRate":"8%","severity":"common","_validated":true},{"effect":"Rash","drugRate":"9%","severity":"common","_validated":true}],"contraindications":["Anemia","Diabetes mellitus","Disease of liver","Drug-induced hepatitis","Hyperglycemia","Interstitial pneumonia","Liver function tests abnormal","Pregnancy, function"],"specialPopulations":{"Pregnancy":"CASODEX is contraindicated for use in pregnant women because it can cause fetal harm. CASODEX is not indicated for use in females. There are no human data on the use of CASODEX in pregnant women. In animal reproduction studies, oral administration of bicalutamide to pregnant rats during organogenesis caused abnormal development of reproductive organs in male fetuses at exposures approximately 0.7 to times the human exposure at the recommended dose (see Data).","Geriatric use":"In two studies in patients given 50 or 150 mg daily, no significant relationship between age and steady-state levels of total bicalutamide or the active R-enantiomer has been shown.","Paediatric use":"The safety and effectiveness of bicalutamide tablets in pediatric patients have not been established.Bicalutamide orodispersible tablet was studied in combination with anastrozole orodispersible tablet in an open-label, non-comparative, multi-center study that assessed the efficacy and safety of this combination regimen over 12 months in the treatment of gonadotropin-independent precocious puberty in boys with familial male-limited precocious puberty, also known as testotoxicosis."}},"trials":[],"aliases":[],"company":"ANI Pharmaceuticals","patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$0.3533/EA","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$129","description":"BICALUTAMIDE 50 MG TABLET","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=bicalutamide","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:46:05.827916+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Bicalutamide","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-19T23:46:18.598366+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:46:17.200010+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-19T23:46:04.940180+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=bicalutamide","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:46:17.543225+00:00"},"mechanism.drugClass":{"url":"https://api.fda.gov/drug/label.json","method":"deterministic","source":"FDA Label (EPC)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:46:01.885624+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:46:01.885657+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:46:01.885662+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-19T23:46:19.057837+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Androgen Receptor antagonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:46:18.598297+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL409/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:46:18.248129+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA079110","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:46:01.885665+00:00"}},"allNames":"casodex","offLabel":[],"synonyms":["ICI 176334","ICI-176334","bicalutamide","casodex"],"timeline":[{"date":"1995-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from ASTRAZENECA to Ani Pharms"},{"date":"1995-10-04","type":"positive","source":"DrugCentral","milestone":"FDA approval (Astrazeneca)"},{"date":"2009-08-28","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 9 manufacturers approved"}],"aiSummary":"Casodex (bicalutamide) is a small molecule androgen receptor inhibitor originally developed by AstraZeneca and currently owned by Ani Pharms. It was FDA-approved in 1995 for the treatment of metastatic prostate carcinoma. As an off-patent medication, Casodex is available as a generic from multiple manufacturers. This medication works by blocking the androgen receptor, which is a protein that helps prostate cancer cells grow. It is a key treatment option for patients with advanced prostate cancer.","brandName":"Casodex","ecosystem":[{"indication":"Metastatic Prostate Carcinoma","otherDrugs":[{"name":"cabazitaxel","slug":"cabazitaxel","company":"Sanofi Aventis Us"},{"name":"estradiol","slug":"estradiol","company":"Bristol Myers Squibb"},{"name":"estradiol cypionate","slug":"estradiol-cypionate","company":"Pharmacia And Upjohn"},{"name":"estradiol valerate","slug":"estradiol-valerate","company":"Par Sterile Products"}],"globalPrevalence":null}],"mechanism":{"target":"Androgen receptor","novelty":"Follow-on","targets":[{"gene":"AR","source":"DrugCentral","target":"Androgen receptor","protein":"Androgen receptor"},{"gene":"CYP2C19","source":"DrugCentral","target":"Cytochrome P450 2C19","protein":"Cytochrome P450 2C19"}],"moaClass":"Androgen Receptor Antagonists","modality":"Small Molecule","drugClass":"Androgen Receptor Inhibitor [EPC]","explanation":". Mechanism of Action. CASODEX is non-steroidal androgen receptor inhibitor. It competitively inhibits the action of androgens by binding to cytosol androgen receptors in the target tissue. Prostatic carcinoma is known to be androgen sensitive and responds to treatment that counteracts the effect of androgen and/or removes the source of androgen.When CASODEX is combined with luteinizing hormone releasing hormone (LHRH) analog therapy, the suppression of serum testosterone induced by the LHRH analog is not affected. However, in clinical trials with CASODEX as single agent for prostate cancer, rises in serum testosterone and estradiol have been noted.In subset of patients who have been treated with CASODEX and an LHRH agonist, and who discontinue CASODEX therapy due to progressive advanced prostate cancer, reduction in Prostate Specific Antigen (PSA) and/or clinical improvement (antiandrogen withdrawal phenomenon) may be observed.","oneSentence":"Casodex works by blocking the androgen receptor, a protein that helps prostate cancer cells grow.","technicalDetail":"Casodex (bicalutamide) is a non-steroidal anti-androgen that competitively binds to the androgen receptor, preventing the binding of androgens (such as testosterone and dihydrotestosterone) and thereby inhibiting the growth and proliferation of prostate cancer cells."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Bicalutamide","title":"Bicalutamide","extract":"Bicalutamide, sold under the brand name Casodex among others, is an antiandrogen medication that is primarily used to treat prostate cancer. It is typically used together with a gonadotropin-releasing hormone (GnRH) analogue or surgical removal of the testicles to treat metastatic prostate cancer (mPC). To a lesser extent, it is used at high doses for locally advanced prostate cancer (LAPC) as a monotherapy without castration. Bicalutamide was also previously used as monotherapy to treat localized prostate cancer (LPC), but authorization for this use was withdrawn following unfavorable trial findings. Besides prostate cancer, bicalutamide is limitedly used in the treatment of excessive hair growth and scalp hair loss in women, as a puberty blocker and component of feminizing hormone therapy for transgender girls and women, to treat gonadotropin-independent early puberty in boys, and to prevent overly long-lasting erections in men. It is taken by mouth.","wiki_history":"==History==\nBicalutamide as well as all of the other currently marketed were derived from structural modification of flutamide, which itself was originally synthesized as a bacteriostatic agent in 1967 at Schering Plough Corporation and was subsequently and serendipitously found to possess antiandrogenic activity. Bicalutamide was discovered by Tucker and colleagues at Imperial Chemical Industries (ICI) in the 1980s and was selected for development from a group of over 2,000 synthesized compounds. It was first patented in 1982 and was first reported in the scientific literature in June 1987.\n\nBicalutamide was first studied in a phase I clinical trial in 1987 The pharmaceutical division of was split out into an independent company called Zeneca in 1993, and in April and May 1995, Zeneca (now AstraZeneca, after merging with Astra AB in 1999) began pre-approval marketing of bicalutamide for the treatment of prostate cancer in the . It was first launched in the in May 1995, and was subsequently approved by the on 4 October 1995, for the treatment of prostate cancer at a dosage of 50 mg/day in combination with a analogue.\n\nFollowing its introduction for use in combination with a analogue, bicalutamide was developed as a monotherapy at a dosage of 150 mg/day for the treatment of prostate cancer, and was approved for this indication in Europe, Canada, and a number of other countries in the late 1990s and early 2000s. This application of bicalutamide was also under review by the in the in 2002, but ultimately was not approved in this country.\n\nSubsequent to negative findings of bicalutamide monotherapy for in the clinical programme, approval of bicalutamide for use specifically in the treatment of was withdrawn in a number of countries including the (in October or November 2003) and several other European countries and Canada (in August 2003). In addition, the and Canada explicitly recommended against the use of 150 mg/day bicalutamide for ","wiki_society_and_culture":"==Society and culture==\n\n===Generic names===\nBicalutamide is the generic name of the drug in English and French and its , , , , , , It is also referred to as bicalutamidum in Latin, bicalutamida in Spanish and Portuguese, bicalutamid in German, and bikalutamid in Russian and other Slavic languages. Bicalutamide is also known by its former developmental code name -176,334. It is also marketed under the brand names Bicadex, Bical, Bicalox, Bicamide, Bicatlon, Bicusan, Binabic, Bypro, Calutol, and Ormandyl among others in various countries.\n\nThe patent protection of all three of the first-generation has expired and flutamide and bicalutamide are both available as low-cost generics. Nilutamide, on the other hand, has always been a poor third competitor to flutamide and bicalutamide and, in relation to this fact, has not been developed as a generic and is only available as brand name Nilandron, at least in the \n\n===Sales and usage===\nSales of bicalutamide (as Casodex) worldwide peaked at US$1.3 billion in 2007, In 2014, despite the introduction of abiraterone acetate in 2011 and enzalutamide in 2012, bicalutamide was still the most commonly prescribed drug in the treatment of metastatic castration-resistant prostate cancer (mCRPC). Total sales as of end 2018 were $13.4 billion. Sources:\n|}\n\nBetween January 2007 and December 2009 (a period of three years), 1,232,143 prescriptions of bicalutamide were dispensed in the , or about 400,000 prescriptions per year."},"commercial":{"launchDate":"1995","_launchSource":"DrugCentral (FDA 1995-10-04, ASTRAZENECA)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/367","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=bicalutamide","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=bicalutamide","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Bicalutamide","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T02:35:09.730813","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-19T23:46:22.272641+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"competitors":[{"drugName":"leuprorelin","drugSlug":"leuprorelin","fdaApproval":"1985-04-09","relationship":"same-class"},{"drugName":"goserelin","drugSlug":"goserelin","fdaApproval":"1989-12-29","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"triptorelin","drugSlug":"triptorelin","fdaApproval":"2000-06-15","patentExpiry":"Jun 30, 2029","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"histrelin","drugSlug":"histrelin","fdaApproval":"1991-12-24","patentExpiry":"Jun 16, 2026","patentStatus":"Patent protected","relationship":"same-class"}],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"}],"genericName":"bicalutamide","indications":{"approved":[{"name":"Metastatic Prostate Carcinoma","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"Stage D2 metastatic carcinoma of the prostate"}],"offLabel":[{"name":"Advanced Prostatic Carcinoma","source":"DrugCentral","drugName":"bicalutamide","evidenceCount":61,"evidenceLevel":"strong"}],"pipeline":[]},"currentOwner":"Ani Pharms","drugCategory":"established","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"leuprorelin","brandName":"leuprorelin","genericName":"leuprorelin","approvalYear":"1985","relationship":"same-class"},{"drugId":"goserelin","brandName":"goserelin","genericName":"goserelin","approvalYear":"1989","relationship":"same-class"},{"drugId":"triptorelin","brandName":"triptorelin","genericName":"triptorelin","approvalYear":"2000","relationship":"same-class"},{"drugId":"histrelin","brandName":"histrelin","genericName":"histrelin","approvalYear":"1991","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT01251861","phase":"PHASE2","title":"Bicalutamide With or Without Akt Inhibitor MK2206 in Treating Patients With Previously Treated Prostate Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2010-12-23","conditions":["Recurrent Prostate Carcinoma","Stage I Prostate Cancer AJCC v7","Stage IIA Prostate Cancer AJCC v7","Stage IIB Prostate Cancer AJCC v7","Stage III Prostate Cancer AJCC v7"],"enrollment":108,"completionDate":"2026-03-18"},{"nctId":"NCT02531516","phase":"PHASE3","title":"An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS","status":"ACTIVE_NOT_RECRUITING","sponsor":"Aragon Pharmaceuticals, Inc.","startDate":"2015-11-19","conditions":["Prostatic Neoplasms"],"enrollment":1503,"completionDate":"2028-12-29"},{"nctId":"NCT07182279","phase":"PHASE1,PHASE2","title":"Neoadjuvant High Dose Rate Brachytherapy Prior to Radical Prostatectomy in Patients With Prostate Cancer","status":"RECRUITING","sponsor":"The Methodist Hospital Research Institute","startDate":"2025-08-01","conditions":["Prostate Cancer (Adenocarcinoma)"],"enrollment":29,"completionDate":"2026-11-14"},{"nctId":"NCT00936390","phase":"PHASE3","title":"Radiation Therapy With or Without Androgen-Deprivation Therapy in Treating Patients With Prostate Cancer","status":"COMPLETED","sponsor":"Radiation Therapy Oncology Group","startDate":"2009-09","conditions":["Prostate Cancer"],"enrollment":1538,"completionDate":"2025-09-04"},{"nctId":"NCT01546987","phase":"PHASE3","title":"Hormone Therapy, Radiation Therapy, and Steroid 17alpha-monooxygenase TAK-700 in Treating Patients With High-Risk Prostate Cancer","status":"COMPLETED","sponsor":"Radiation Therapy Oncology Group","startDate":"2012-05","conditions":["Prostate Cancer"],"enrollment":239,"completionDate":"2025-09-04"},{"nctId":"NCT07455903","phase":"PHASE2","title":"Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT","status":"NOT_YET_RECRUITING","sponsor":"Baptist Health South Florida","startDate":"2026-04","conditions":["Prostate Cancer","Localized Prostate Carcinoma"],"enrollment":50,"completionDate":"2030-10"},{"nctId":"NCT05700903","phase":"PHASE4","title":"Contributions to Hypertension With Androgen Deprivation 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