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Pivotal Phase 3 Study Published in The New England Journal of Medicine (NEJM) Finds Overall Survival of Patients with Metastatic Castration-Resistant Prostate Cancer is Significantly Improved with ZYTIGA™ (abiraterone acetate)
Date:5/25/2011

ho have received prior chemotherapy containing docetaxel.

Important Safety Information

Contraindications

ZYTIGA may cause fetal harm (Pregnancy Category X) and is contraindicated in women who are or may become pregnant.

Warnings and Precautions

Hypertension, Hypokalemia and Fluid Retention Due to Mineralocorticoid Excess
Use with caution in patients with a history of cardiovascular disease or with medical conditions that might be compromised by increases in hypertension, hypokalemia and fluid retention.  Safety has not been established in patients with LVEF < 50% or NYHA Class III or IV heart failure.  Control hypertension and correct hypokalemia before and during treatment.  Monitor blood pressure, serum potassium, and symptoms of fluid retention at least monthly.

Adrenocortical Insufficiency (AI) has been reported in clinical trials after an interruption of daily steroids and/or with concurrent infection or stress.  Use caution and monitor for symptoms and signs of AI if prednisone is stopped or withdrawn or if the patient experiences unusual stress.  Perform appropriate tests, if indicated, to confirm AI.  Increased dosages of corticosteroids may be used before, during and after stressful situations.

Hepatotoxicity - Increases in liver enzymes have led to drug interruption, dose modification and/or discontinuation.  Monitor liver function and modify, withhold or discontinue ZYTIGA™ dosing as recommended (See Prescribing Information for more information).

Food Effect - ZYTIGA™ must be taken on an empty stomach.  Exposure of abiraterone increases up to 10-fold when abiraterone acetate is taken with meals.  No food should be eaten for at least two hours before the dose of ZYTIGA™ is taken and for at least one hour after the dose of ZYTIGA™ is taken.

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SOURCE Centocor Ortho Biotech Inc.
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