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Important Information About CASODEX (bicalutamide) Tablets

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.

Important Safety Information About CASODEX

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 click here for full Prescribing Information for CASODEX.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

Important Information About ZOLADEX (goserelin acetate implant)

ZOLADEX is a prescription medication approved for use in combination with flutamide (an antiandrogen) plus radiotherapy for locally advanced prostate cancer. Treatment with the combination should start 8 weeks prior to starting and continue during radiation therapy.

ZOLADEX is also approved to use alone for patients with advanced prostate cancer. ZOLADEX may help reduce the size of your cancer and reduce your symptoms (palliative treatment).

Important Safety Information About ZOLADEX

ZOLADEX, like other luteinizing hormone-releasing hormone analogs (LHRH-As), may cause an initial rise in testosterone. When used alone, there may be a temporary worsening of prostate cancer symptoms at the start of therapy.

Common side effects that occurred during treatment with ZOLADEX plus flutamide and radiation therapy or ZOLADEX alone included hot flashes, decrease in sexual desire and/or ability to have erections, diarrhea, pain (general, pelvic, and bone), lower urinary tract symptoms, fatigue, nausea, breast growth, swelling, rash, upper respiratory infection, and sweating.

Please click here for full Prescribing Information for ZOLADEX 3.6 mg 1-month Depot.
Please click here for full Prescribing Information for ZOLADEX 10.8 mg 3-month Depot.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.