Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
BICALUTAMIDE (UNII: A0Z3NAU9DP) (BICALUTAMIDE - UNII:A0Z3NAU9DP)
Northstar RxLLC
BICALUTAMIDE
BICALUTAMIDE 50 mg
ORAL
PRESCRIPTION DRUG
Bicalutamide 50 mg daily is 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 150 mg daily is not approved for use alone or with other treatments [see Clinical Studies (14.2)] . 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)] . 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
Bicalutamide tablets, USP are available as follows: 50 mg – White, round, film-coated, biconvex tablets marked with “B 50” on one side with “” on the other side are supplied in bottles of 30 tablets (NDC 16714-571-01), 100 tablets (NDC 16714-571-02), and 500 tablets (NDC 16714-571-03). Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Dispense in a tight, light-resistant container as defined in the USP.
Abbreviated New Drug Application
BICALUTAMIDE- BICALUTAMIDE TABLET, FILM COATED NORTHSTAR RXLLC ---------- 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 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 metastatic carcinoma of the prostate. (1) Bicalutamide 150 mg daily is 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 Prostate Specific Antigen (PSA) i Citiți documentul complet