CASODEX (bicalutamide) 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 (bicalutamide) 150 mg daily is not approved for use alone or with other treatments [see Clinical Studies].

The recommended dose for CASODEX (bicalutamide) therapy in combination with an LHRH analog is one 50 mg tablet once daily (morning or evening), with or without food. It is recommended that CASODEX (bicalutamide) be taken at the same time each day. Treatment with CASODEX (bicalutamide) should be started at the same time as treatment with an LHRH analog.

Dosage Adjustment in Renal Impairment

No dosage adjustment is necessary for patients with renal impairment [see Use in Specific Populations].

Dosage Adjustment in Hepatic Impairment

No dosage adjustment is necessary for patients with mild to moderate hepatic impairment. In patients with severe liver impairment (n=4), although there was a 76% increase in the half-life (5.9 and 10.4 days for normal and impaired patients, respectively) of the active enantiomer of bicalutamide no dosage adjustment is necessary [see Use in Specific Populations].

Dosage Forms And Strengths

CASODEX® (bicalutamide) 50 mg Tablets for oral administration.

White, film-coated tablets (identified on one side with "CDX50" and on the reverse with the "CASODEX (bicalutamide) logo") are supplied in unit dose blisters of 30 tablets per carton (0310-0705-39), bottles of 30 tablets (0310-0705-30) and bottles of 100 tablets (0310-0705-10).

Storage and Handling

Store at controlled room temperature, 20°-25°C (68°-77°F).

AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850.

Last reviewed on RxList: 3/13/2009
This monograph has been modified to include the generic and brand name in many instances.