Now More Men with Metastatic Castration-Resistant Prostate Cancer May Benefit from Treatment with ZYTIGA®

ZYTIGA® plus prednisone is used to treat men who have castration-resistant prostate cancer (defined as prostate cancer that is resistant to medical or surgical treatments that lower testosterone) that has spread to other parts of the body (mCRPC).

If you're living with metastatic castration-resistant prostate cancer, your treatment journey to this point has probably been a difficult one. Whether you're the patient or the caregiver, you may be wondering about where to go from here.

What Can ZYTIGA® Do for Me?

In a new study of men with metastatic castration-resistant prostate cancer who had not received chemotherapy:

  • Certain men treated with ZYTIGA® plus prednisone lived longer than men treated with placebo plus prednisone (median overall survival was 35.3 months for men treated with ZYTIGA® plus prednisone compared with 30.1 months for men treated with placebo [sugar pill] plus prednisone). However, the difference was not statistically significant.
  • ZYTIGA® plus prednisone increased the length of time certain men lived with the disease but did not get worse as measured by imaging studies1 (i.e., bone scans). One hundred fifty of 546 men (28%) treated with ZYTIGA® plus prednisone and 251 of 542 men (46%) treated with placebo (sugar pills) plus prednisone had disease progression.
  • ZYTIGA® plus prednisone significantly delayed the median time to starting chemotherapy (25.2 months for patients receiving ZYTIGA® plus prednisone and 16.8 months for patients receiving placebo [sugar pill] plus prednisone).

ZYTIGA® can also be used in men with mCRPC who have received chemotherapy with docetaxel

Results from a clinical trial showed that certain men with mCRPC* who had received chemotherapy with docetaxel and who were treated with ZYTIGA® plus prednisone lived longer than men who were treated with placebo (sugar pill) plus prednisone. In the clinical trial, the median survival for men treated with ZYTIGA® plus prednisone was 15.8 months versus 11.2 months for men treated with placebo plus prednisone.

Talk to your doctor about how you may be able to benefit from treatment with ZYTIGA®.

ZYTIGA® may cause serious side effects, including:

High blood pressure (hypertension), low blood potassium (hypokalemia), and fluid retention (edema).

Tell your healthcare provider if you get any of the following symptoms:

  • Dizziness
  • Fast heartbeats
  • Feel faint or lightheaded
  • Headache
  • Confusion
  • Muscle weakness
  • Pain in your legs
  • Swelling in your legs or feet

Adrenal problems may happen if you stop taking prednisone, get an infection, or are under stress.

Liver problems. You may develop changes in liver function blood test. Your healthcare provider will do blood tests to check your liver before treatment with ZYTIGA® and during treatment with ZYTIGA®.

The most common side effects of ZYTIGA® include:

  • Weakness
  • Joint swelling or pain
  • Swelling in your legs or feet
  • Hot flushes
  • Diarrhea
  • Vomiting
  • Cough
  • High blood pressure
  • Shortness of breath
  • Urinary tract infection
  • Bruising
  • Low red blood cells (anemia) and low blood potassium levels
  • High blood sugar levels, high blood cholesterol and triglycerides
  • Certain other abnormal blood tests

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

THESE ARE NOT ALL THE POSSIBLE SIDE EFFECTS OF ZYTIGA®. FOR MORE INFORMATION, ASK YOUR HEALTHCARE PROVIDER OR PHARMACIST.

Please see additional Important Safety Information below.

  • 1 "PFS." NCI Dictionary of Cancer Terms. National Cancer Institute, n.d. Web. 11 Dec. 2012.
  • The median is the middle number in a group of numbers (such as overall survival results) that are arranged from lowest to highest. For example, in the group of numbers 1 to 11, 6 is the median.

What is ZYTIGA®?

ZYTIGA® (abiraterone acetate) is a prescription medicine that is used along with prednisone. ZYTIGA® is used to treat men with castration-resistant prostate cancer (prostate cancer that is resistant to medical or surgical treatments that lower testosterone) that has spread to other parts of the body.

IMPORTANT SAFETY INFORMATION

Who should not take ZYTIGA®?

Do not take ZYTIGA® if you are pregnant or may become pregnant. ZYTIGA® may harm your unborn baby. Women who are pregnant or who may become pregnant should not touch ZYTIGA® without protection, such as gloves.

ZYTIGA® is not for use in women or children. Keep ZYTIGA® and all medicines out of the reach of children.

Before you take ZYTIGA®, tell your healthcare provider if you:

If you are taking ZYTIGA®:

ZYTIGA® may cause serious side effects including:

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

THESE ARE NOT ALL THE POSSIBLE SIDE EFFECTS OF ZYTIGA®.
FOR MORE INFORMATION, ASK YOUR HEALTHCARE PROVIDER OR PHARMACIST.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

ZYTIGA® can interact with other medicines.

You should not start or stop any medicine before you talk with the healthcare provider that prescribed ZYTIGA®.

Know the medicines you take. Keep a list of them with you to show to your healthcare provider and pharmacist when you get a new medicine.

Call your doctor for medical advice about side effects. 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 (1-800-332-1088).

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