Important safety information about CASODEX® (bicalutamide).

CASODEX at a dose of 50 mg daily is a prescription medication approved for use in combination with an injection of a luteinizing hormone-releasing hormone analog (LHRH-A) for treatment of advanced prostate cancer (metastatic Stage D2).

CASODEX at a dose of 150 mg daily is not approved for use alone or with other treatments. See full Prescribing Information under the section on "CLINICAL PHARMACOLOGY–Clinical Studies–Safety Data from Clinical Studies using CASODEX 150 mg" for additional important safety information regarding CASODEX 150 mg.

There have been reports of liver function problems during treatment with CASODEX. Therefore, your doctor will monitor your liver function with a blood test before you start treatment with CASODEX, at regular intervals during the first 4 months of treatment, and at regular times after that.

The most common side effects that occurred during treatment with CASODEX plus an injection of an LHRH-A were hot flashes (53%), pain (21% to 35%, including pelvic, back, and general), weakness (22%), and constipation (22%). Other side effects (reported in 12% to 18% of patients) were urination at night, blood in urine, diarrhea, swelling, shortness of breath, nausea, and infection.

Please see accompanying full Prescribing Information.

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