CASODEX 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analogue 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 PHARMACOLOGY-Clinical Studies- Safety Data from Clinical Studies using CASODEX 150 mg section for additional important safety information regarding CASODEX 150 mg.

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

No dosage adjustment is necessary for patients with renal impairment (see CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency).

No dosage adjustment is necessary for patients with mild to moderate hepatic impairment. Although there is a 76% (5.9 and 10.4 days for normal and impaired patients, respectively) increase in the half-life of the active enantiomer of bicalutamide in patients with severe liver impairment (n=4), no dosage adjustment is necessary (see CLINICAL PHARMACOLOGY, Special Populations, Hepatic Impairment, PRECAUTIONS and WARNINGS sections).

50 mg Tablets:

(NDC 0310-0705) White, film-coated tablets (identified on one side with "CDX50" and on the reverse with the "CASODEX 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). Store at controlled room temperature, 20° -25° C (68° -77° F).

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