BICALUTAMIDE- bicalutamide tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BICALUTAMIDE (UNII: A0Z3NAU9DP) (BICALUTAMIDE - UNII:A0Z3NAU9DP)

Available from:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

BICALUTAMIDE

Composition:

BICALUTAMIDE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BICALUTAMIDE- BICALUTAMIDE TABLET, FILM COATED
TEVA PHARMACEUTICALS USA, INC.
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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