BICALUTAMIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Apotex Corp.

INN (International Name):

BICALUTAMIDE

Composition:

BICALUTAMIDE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Bicalutamide tablets 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 tablets 150 mg daily is not approved for use alone or with other treatments [see Clinical Studies (14.2)] . 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 [see Adverse Reactions (6.2)] . Bicalutamide has no indication for women, and should not be used in this population. Bicalutamide may cause fetal harm when administered to a pregnant woman. Bicalutamide is contraindicated in women, including those who are or may become pregnant. There are no studies in pregnant women using bicalutamide. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be appraise

Product summary:

Bicalutamide tablets 50 mg are white to off-white, round, biconvex, film coated tablets, debossed ‘B 50’ on one side and plain on other side and supplied in bottles of 30 tablets (NDC 60505-2642-3) and bottles of 100 tablets (NDC 60505-2642-1). “Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature]”

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BICALUTAMIDE- BICALUTAMIDE TABLET
APOTEX CORP.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BICALUTAMIDE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR BICALUTAMIDE.
BICALUTAMIDE TABLETS USP FOR ORAL USE
INITIAL U.S. APPROVAL : 1995
INDICATIONS AND USAGE
Bicalutamide tablets 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.
Bicalutamide tablets 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 (4.1)
Women (4.2)
Pregnancy (4.3 and 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)
Gynecomastia and breast pain have been reported during treatment with
bicalutamide 150 mg when used as a single
agent. (5.2)
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. (5.3)
Monitoring Prostate Specific Antigen (PSA) is recommended. Evaluate
for clinical progression if PSA increases. (5.4)
ADVERSE REACTIONS
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)