BICALUTAMIDE tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Major Pharmaceuticals

INN (International Name):

BICALUTAMIDE

Sammensætning:

BICALUTAMIDE 50 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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: 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. Bicalutamide has no indication for women, and should not be used in this population. 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 c

Produkt oversigt:

“Store at 20° to 25°C (68 to 77°F). [See USP Controlled Room Temperature]”

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

BICALUTAMIDE- BICALUTAMIDE TABLET
MAJOR PHARMACEUTICALS
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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
INDICATIONS AND USAGE
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
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WARNINGS AND PRECAUTIONS
•
•
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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), asthenia, constipation, infection,
nausea, peripheral edema, dyspnea, diarrhea, hematuria, nocturia and
anemia. ( 6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ACCORD HEALTHCARE INC.
AT 1-866-941-
7875 OR WWW.ACCORDHEALTHCARE.US OR FDA AT 1-800-FDA-1088 OR
WWW.FDA.GOV/MEDWATCH
DRUG INTERACTIONS
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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)
2
Bicalutamide tablets 150 mg daily is not approved for use alone or
with other treatments. ( 1)
Hypersensitivity ( 4)
Women ( 4)
Pregnancy ( 4, and 8.1)
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),