BICALUTAMIDE tablet

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Bryant Ranch Prepack

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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 D 2 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: - 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 contraindica

Резиме производа:

Product: 63629-8308 NDC: 63629-8308-1 30 TABLET in a BOTTLE NDC: 63629-8308-2 100 TABLET in a BOTTLE

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

BICALUTAMIDE- BICALUTAMIDE TABLET
BRYANT RANCH PREPACK
----------
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
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. ( 1)
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)
Women ( 4)
Pregnancy ( 4, 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)
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) is recommended. Evaluate
for clinical