CASODEX- bicalutamide tablet

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Physicians Total Care, Inc.

INN (Међународно име):

BICALUTAMIDE

Састав:

BICALUTAMIDE 50 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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

Резиме производа:

White, film-coated tablets (identified on one side with "CDX50" and on the reverse with the "CASODEX logo") are supplied in bottles of 30 tablets (NDC 54868-4503-0). Store at controlled room temperature, 20°-25°C (68°-77°F).

Статус ауторизације:

New Drug Application

Карактеристике производа

CASODEX - BICALUTAMIDE TABLET
PHYSICIANS TOTAL CARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CASODEX® SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR CASODEX.
CASODEX® (BICALUTAMIDE) TABLET FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
CASODEX 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)
CASODEX 150 mg daily is not approved for use alone or with other
treatments. (1) (1)
(1)
DOSAGE AND ADMINISTRATION
The recommended dose for CASODEX therapy in combination with an LHRH
analog is one 50 mg tablet once daily
(morning or evening). (2) (2)
DOSAGE FORMS AND STRENGTHS
50 mg tablets (3) (3)
CONTRAINDICATIONS
• Hypersensitivity (4.1) (4)
• Women (4.2) (4)
• Pregnancy (4.3 and 8.1) (4)
WARNINGS AND PRECAUTIONS
• Severe hepatic injury and fatal hepatic failure have been
observed. Monitor serum transaminase levels prior to starting
treatment with CASODEX, at regular intervals for the first four months
of treatment and periodically thereafter, and for
symptoms or signs suggestive of hepatic dysfunction. Use CASODEX with
caution in patients with hepatic impairment.
(5.1) (5)
• Gynecomastia and breast pain have been reported during treatment
with CASODEX 150 mg when used as a single agent.
(5.2) (5)
• CASODEX is used in combination with a 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 CASODEX in
combination with LHRH agonists. (5.3) (5)
(5)
• Monitoring Prostate Specific Antigen (PSA) is recommended.
Evaluate for clinical progression if PSA increases. (5.4) (5)
ADVERSE REACTIONS
Adverse reactions that occurred in more than 10% of patients receiving
CASODEX plus an LHRH-A were: hot flashes, pain
(including general,