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2009

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Prescribing Information

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Important Information About CASODEX (bicalutamide) Tablets

CASODEX 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone analog (LHRH-A) 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 in the full Prescribing Information for additional important safety information regarding CASODEX 150 mg.

Important Safety Information About CASODEX

Serum transaminase levels should be measured prior to starting treatment with CASODEX, at regular intervals for the first four months of treatment, and periodically thereafter.

The most commonly reported adverse events regardless of causality for CASODEX plus an LHRH-A were hot flashes (53%), pain (35%), back pain (25%), asthenia (22%), constipation (22%), pelvic pain (21%), infection (18%), nausea (15%), dyspnea (13%), peripheral edema (13%), diarrhea (12%), hematuria (12%), and nocturia (12%).

Please click here for full Prescribing Information for CASODEX.

Important Information About ZOLADEX (goserelin acetate implant)

ZOLADEX is indicated in the palliative treatment of advanced carcinoma of the prostate.

ZOLADEX is also indicated for use in combination with flutamide for the management of locally advanced Stage T2b-T4 (Stage B2-C) carcinoma of the prostate. Treatment with the combination should start 8 weeks prior to initiating radiation therapy and continue during radiation therapy.

Important Safety Information About ZOLADEX

ZOLADEX is indicated in the palliative treatment of advanced carcinoma of the prostate.

The most common adverse events (incidence > 5% in clinical trials) were: for ZOLADEX 3.6 mg depot — hot flashes (62%), sexual dysfunction (21%), decreased erections (18%), lower urinary tract symptoms (13%), lethargy (8%), pain (worsened in the first 30 days) (8%), edema (7%), upper respiratory infection (7%), rash (6%), and sweating (6%). For ZOLADEX 10.8 mg depot — hot flashes (64%), pain (general) (14%), gynecomastia (8%), pelvic pain (6%), and bone pain (6%).

Additional adverse event data were collected for the combination therapy with radiation group during both the hormonal treatment and hormonal treatment plus radiation phases of this study. Adverse experiences (incidence > 5%) in both phases of this study were hot flashes (46%), diarrhea (40%), nausea (9%), and skin rash (8%).

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.

CASODEX and ZOLADEX are registered trademarks of the AstraZeneca group of companies.

This information is intended for US health care professionals only.

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