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U.S. FDA Approves Expanded ZYTIGA® Indication For Treatment Of Metastatic Castration-Resistant Prostate Cancer

About ZYTIGASince its first approval in the U.S. in 2011, ZYTIGA has been approved in more than 65 countries.  More than 40,000 men worldwide have received treatment with it, and it is quickly becoming one of the cornerstones of treatments.

ZYTIGA in combination with prednisone was approved by the U.S. Food and Drug Administration (FDA) in April 2011 for the treatment of men with mCRPC who have received prior chemotherapy containing docetaxel. 

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

About ZYTIGAOne SupportZytigaOne™ Support provides simplified access to ZYTIGA ®.  ZytigaOne™ Support handles rapid investigation and assessment of patient eligibility and coverage, assistance with the prior authorization process, the coordination with specialty pharmacies to arrange efficient handling and convenient shipment of ZYTIGA ®, immediate and direct access to the ZytigaOne™ Instant Savings Program, referrals to a patient assistance program and identification of alternate sources of funding for eligible patients. ZytigaOne™ Support also offers educational materials and personalized prescription reminders. A personally assigned Care Coordinator provides assistance with insurance coverage questions and navigation. 

The ZytigaOne™ Instant Savings Program provides eligible, commercially insured ZYTIGA ® patients with assistance for out-of-pocket costs.

IndicationZYTIGA ® (abiraterone acetate) in combination with prednisone is indicated 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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