CASODEX- bicalutamide tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

AstraZeneca Pharmaceuticals LP

INN (International Name):

BICALUTAMIDE

Composition:

BICALUTAMIDE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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: 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. CASODEX has no indication for women, and should not be used in this population. CASODEX can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)] . Risk Summary CASODEX is contraindicated for use in pregnant women because it can cause fetal harm. CASODEX is not indicated for use in females. There are no human data on the use of CASODEX in pregnant women. In animal reproduction studies, oral administration of bicalutamide to p

Product summary:

White, film-coated tablets (identified on one side with "CDX50" and on the reverse with the "CASODEX logo") are supplied in unit dose bottles of 30 tablets (0310-0705-30). Store at controlled room temperature, 20°-25°C (68°-77°F).

Authorization status:

New Drug Application

Summary of Product characteristics

CASODEX- BICALUTAMIDE TABLET
ASTRAZENECA PHARMACEUTICALS LP
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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
RECENT MAJOR CHANGES
Warnings and Precautions (5.2) 5/2017
INDICATIONS AND USAGE
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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)
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
CASODEX 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 ASTRAZENECA
PHARMACEUTICALS LP AT 1-800-236-9933 OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
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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)
2
CASODEX 150 mg daily is not approved for use alone or with other
treatments. (1)
Hypersensitivity (4)
Women (4)
Pregnancy (4, 8.1)
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)
Hemorrhage with Concomitant Use of Coumarin Anticoagulant. Closely
monitor the Prothrombin Time (PT) and
International Normalized