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Follow-up Data Show ZYTIGA® Plus Prednisone Continues To Delay Progression Of Metastatic Castration-Resistant Prostate Cancer In Patients Without Prior Chemotherapy

About ZYTIGA Since its first approval in the U.S. in 2011, ZYTIGA has been approved in more than 65 countries.  More than 50,000 men worldwide have received treatment with ZYTIGA, and it is quickly becoming one of the cornerstones of treatments with mCRPC.

More information about ZYTIGA can be found at www.zytiga.com.

IndicationZYTIGA ® (abiraterone acetate) is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).

IMPORTANT SAFETY INFORMATION

Contraindications - ZYTIGA ® (abiraterone acetate) is not indicated for use in women.  ZYTIGA ® can cause fetal harm (Pregnancy Category X) when administered to a pregnant woman and is contraindicated in women who are or may become pregnant.

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 blood pressure, hypokalemia, or fluid retention. ZYTIGA ® may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition.  Safety has not been established in patients with LVEF <50% or New York Heart Association (NYHA) Class III or IV heart failure (in study 1) or NYHA Class II to IV heart failure (in study 2) because these patients were excluded from these randomized clinical trials.  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) - AI was reported in patients receiving ZYTIGA ® in combination with prednisone, 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  Use caution and monitor for symptoms and signs of AI if prednisone is stopped or withdrawn, if prednisone dose is reduced, or if the patient experiences unusual stress.  Symptoms and signs of AI may be masked by adverse reactions associated with mineralocorticoid excess seen in patients treated with ZYTIGA ®.  Perform appropriate tests, if indicated, to confirm AI. Increased dosages of corticosteroids may be used before, during, and after stressful situations.

Hepatotoxicity - Monitor liver function and modify, withhold, or discontinue ZYTIGA ® dosing as recommended (see Prescribing Information for more information).  Measure serum transaminases [alanine aminotransferase (ALT) and aspartate aminotransferase (AST)] and bilirubin levels prior to starting treatment with ZYTIGA ®, every two weeks for the first three months of treatment, and monthly thereafter.  Promptly measure serum total bilirubin, AST, and ALT if clinical symptoms or signs suggestive of hepatotoxicity develop.  Elevations of AST, ALT, or bilirubin from the patient's baseline should prompt more frequent monitoring.  If at any time AST or ALT rise above five times the upper limit of normal (ULN) or the bilirubin rises above three times the ULN, interrupt ZYTIGA ® treatment and closely monitor liver function.

Increased ZYTIGA ® Exposures with Food - ZYTIGA ® must be taken on an empty stomach.  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.  Abiraterone C max and AUC 0-infinity (exposure) were increased up to 17- and 10-fold higher, respectively, when a single dose of abiraterone acetate was administered with a meal compared to a fasted state.

Adverse Reactions - The most common adverse reactions (greater than or equal to 10%) are fatigue, joint swelling or discomfort, edema, hot flush, diarrhea, vomiting, cough, hypertension, dyspnea, urinary tract infection and contusion.

The most common laboratory abnormalities (>20%) are anemia, elevated alkaline phosphatase, hypertriglyceridemia, lymphopenia, hypercholesterolemia, hyperglycemia, elevated AST, hypophosphatemia, elevated ALT and hypokalemia.

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