What is ZYTIGA®?

ZYTIGA® (zy-tee-ga) is an oral, once-daily prescription medication used in combination with prednisone to treat men with advanced prostate cancer.
This prostate cancer is resistant to medical (e.g. hormonal) or surgical treatments that lower testosterone and has spread to other parts of the body (metastatic castration-resistant prostate cancer).

Talk to your doctor to see if ZYTIGA® is right for you.

Since its approval in 2011, more than 60,000 men in the U.S.
have been prescribed ZYTIGA®.1

1Estimate based on sales and use data from April 2011 to August 2014.

What Can ZYTIGA® Do for Me?

Clinical Study Results

In a clinical study of 1,088 men with metastatic castration-resistant prostate cancer (mCRPC) whose disease progressed while on androgen deprivation2 therapy (ADT) and had not received prior chemotherapy:

Certain men who received ZYTIGA® plus prednisone lived longer than men who received placebo plus prednisone.

The median overall survival was 35.3 months for the group of men who received ZYTIGA® plus prednisone, compared to 30.1 months for the group of men who received placebo plus prednisone. This difference, however, did not meet statistical significance. Please speak to your doctor about what this may mean to you.



2 Androgen deprivation—A treatment to suppress or block the production or action of male hormones. (National Cancer Institute: NCI Dictionary of Cancer Terms. Bethesda, MD: National Cancer Institute. 2013. Available at www.cancer.gov/dictionary. Accessed 10/15/2013.)

In the same study, at a planned analysis, fewer men with mCRPC had disease progression as measured by imaging studies in the group who received ZYTIGA® plus prednisone compared to the group who received placebo plus prednisone.

In the group of men who received ZYTIGA® plus prednisone, the median length of time they lived with the disease and it did not get worse (progressed) was longer, compared to the group of men who received placebo plus prednisone. Progression was measured by imaging studies. Please speak to your doctor about what this may mean to you.

28% (150 of 546) of men who received ZYTIGA® plus prednisone had progression, as measured by imaging studies.

46% (251 of 542) of men who received placebo plus prednisone had progression, as measured by imaging studies.

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.

ZYTIGA® plus prednisone delayed the beginning of chemotherapy compared to placebo plus prednisone in certain men with mCRPC.

In the group of men who received ZYTIGA® plus prednisone, the median time to starting chemotherapy was 25.2 months compared to 16.8 months for the group of men who received placebo plus prednisone.

As you have seen, in a clinical study at a planned analysis, certain men with mCRPC who received ZYTIGA® plus prednisone lived longer and the median time their disease did not progress as measured by imaging studies was longer, compared to those who received placebo plus prednisone. ZYTIGA® plus prednisone also delayed the start of chemotherapy in certain men with mCRPC as compared to placebo plus prednisone.

In an updated analysis of another study of 1,195 men with mCRPC who had already received chemotherapy with docetaxel:

Certain men with mCRPC who had already received chemotherapy with docetaxel and who received ZYTIGA® plus prednisone lived longer than those who received placebo plus prednisone.

After taking ZYTIGA® plus prednisone, certain men with mCRPC who had already received chemotherapy with docetaxel lived significantly longer than those who received placebo plus prednisone. In the updated analysis of the clinical trial, the median overall survival for men who received ZYTIGA® plus prednisone was 15.8 months, versus 11.2 months for men who received placebo plus prednisone. The primary analysis had shown that the median overall survival for men who received ZYTIGA® plus prednisone was 14.8 months, versus 10.9 months for men who received placebo plus prednisone.

Talk with your doctor to see if ZYTIGA® is right for you.

ZYTIGA® May Cause Serious Side Effects

ZYTIGA® has an established safety profile. Please read the information about side effects and important safety information listed below and discuss taking ZYTIGA® with your doctor.

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.

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®(abiraterone acetate)?

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:

  • Have heart problems
  • Have liver problems
  • Have a history of adrenal problems
  • Have a history of pituitary problems
  • Have any other medical conditions
  • Plan to become pregnant (See "Who should not take ZYTIGA®?")
  • Are breastfeeding or plan to breastfeed. It is not known if ZYTIGA® passes into your breast milk. You and your healthcare provider should decide if you will take ZYTIGA® or breastfeed. You should not do both. (See "Who should not take ZYTIGA®?")
  • Take any other medicines, including prescription and non-prescription medicines, vitamins, and herbal supplements. ZYTIGA® can interact with many other medicines.

If you are taking ZYTIGA®:

  • Take ZYTIGA® and prednisone exactly as your healthcare provider tells you.
  • Take your prescribed dose of ZYTIGA® one time a day. Your healthcare provider may change your dose if needed.
  • Do not stop taking your prescribed dose of ZYTIGA® or prednisone without talking to your healthcare provider first.
  • Take ZYTIGA® on an empty stomach. Do not take ZYTIGA® with food. Taking ZYTIGA® with food may cause more of the medicine to be absorbed by the body than is needed and this may cause side effects.
  • No food should be eaten 2 hours before and 1 hour after taking ZYTIGA®.
  • Swallow ZYTIGA® tablets whole. Do not crush or chew tablets.
  • Take ZYTIGA® tablets with water.
  • Your healthcare provider will do blood tests to check for side effects.
  • Men who are sexually active with a pregnant woman must use a condom during and for one week after treatment with ZYTIGA®. If their sexual partner may become pregnant a condom and another form of birth control must be used during and for one week after treatment with ZYTIGA®. Talk with your healthcare provider if you have any questions about birth control.

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.

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

ZYTIGA® can interact with many other medicines.

You should not start or stop any medicine before you talk with the healthcare provider who 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).