Country: United States
Language: English
Source: NLM (National Library of Medicine)
BICALUTAMIDE (UNII: A0Z3NAU9DP) (BICALUTAMIDE - UNII:A0Z3NAU9DP)
Teva Pharmaceuticals USA, Inc.
BICALUTAMIDE
BICALUTAMIDE 50 mg
ORAL
PRESCRIPTION DRUG
Bicalutamide tablets 50 mg daily are indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of the prostate. Bicalutamide tablets 150 mg daily are not approved for use alone or with other treatments [see Clinical Studies (14.2) ]. Bicalutamide tablets are contraindicated in: - Hypersensitivity Bicalutamide tablets are 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 tablets have no indication for women, and should not be used in this population. - Pregnancy Bicalutamide tablets can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ]. Risk Summary Bicalutamide is contraindicated for use in pregnant women because it can cause fetal harm. Bicalutamide is not indicated for use in f
Bicalutamide tablets USP are available as follows: 50 mg - white, film-coated, round tablets, debossed with “93” on one side and “220” on the other side, in bottles of 30 (NDC 0093-0220-56) and 100 (NDC 0093-0220-01). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Abbreviated New Drug Application
BICALUTAMIDE- BICALUTAMIDE TABLET, FILM COATED TEVA PHARMACEUTICALS USA, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE BICALUTAMIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BICALUTAMIDE TABLETS. BICALUTAMIDE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1995 RECENT MAJOR CHANGES Warnings and Precautions (5.2) 10/2017 INDICATIONS AND USAGE Bicalutamide tablets 50 mg are an androgen receptor inhibitor indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D metastatic carcinoma of the prostate. (1) Bicalutamide tablets 150 mg daily are not approved for use alone or with other treatments. (1) DOSAGE AND ADMINISTRATION The recommended dose for bicalutamide therapy in combination with an LHRH analog is one 50 mg tablet once daily (morning or evening). (2) DOSAGE FORMS AND STRENGTHS 50 mg tablets (3) CONTRAINDICATIONS Hypersensitivity (4) Women (4) Pregnancy (4, 8.1) 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 Read the complete document