Frequently Asked Questions About ZYTIGA®

This list of Frequently Asked Questions provides quick, basic answers about ZYTIGA® (abiraterone acetate), with links to sections of this site that provide additional information.

What is ZYTIGA®?

ZYTIGA® 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.

How does ZYTIGA® work?

ZYTIGA® works by interrupting the androgen-making process at an important step thereby reducing the amount of androgen being made.

ZYTIGA® blocks androgen production at three sources — the testes, the adrenal glands, and the tumor itself.

How was ZYTIGA® proven effective?

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.

  • 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 should I tell my healthcare provider before taking ZYTIGA®?

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® and breastfeed. You should not do both. (See: "Who should not take ZYTIGA®?")
  • Take any other medicines, including prescription and nonprescription medicines, and herbal supplements. ZYTIGA® can interact with many other medicines

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.

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 may become pregnant should not touch ZYTIGA® without protection, such as gloves.

How should I take 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 with 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 questions about birth control.
  • If you miss a dose of ZYTIGA® or prednisone, take your prescribed dose the following day. If you miss more than 1 dose, tell your healthcare provider right away.

What are the possible side effects of ZYTIGA®?

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 nonprescription 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 levels (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 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.

What should I do if I miss a daily dose of ZYTIGA®?

  • If you miss a dose of ZYTIGA® or prednisone, take your prescribed dose the following day. If you miss more than one dose of ZYTIGA® or prednisone, tell your healthcare provider right away.

What are the options to help cover the cost of my medication?

There are several options for reducing your out-of-pocket costs for ZYTIGA®:

  • If you have commercial insurance, and are eligible for an Instant Savings Card, you'll pay only $10 per month after you've activated your card. This is subject to a $12,000 annual program benefit, 12 months after activation or 12 monthly refills (one-year supply), whichever comes first.
  • If You Have Medicare, Medicaid, or TRICARE or Commercial Insurance for ZYTIGA®, ZytigaOne™ Support can direct you to alternate sources of funding.
  • If You're Uninsured

    If you meet certain requirements, you may be able to get funding assistance from the Johnson & Johnson Patient Assistance Foundation.
    Johnson & Johnson Patient Assistance Foundation, Inc. is committed to providing access to uninsured patients that lack the financial resources to pay for their medicines. If you need ZYTIGA® (abiraterone acetate) and are uninsured and unable to pay for your medicine, please call the program at 800-652-6227 or visit the foundation website at http://www.jjpaf.org to see if you might qualify for assistance.



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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