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WHAT IS ZYTIGA®?

ZYTIGA® (abiraterone acetate) is a prescription medicine that is used along with prednisone. ZYTIGA® is used to treat men with prostate cancer that has spread to other parts of the body.

It is not known if ZYTIGA® is safe and effective in females or children.

Important Safety Information

Important Safety Information

Before taking ZYTIGA®, tell your healthcare provider about all of your medical conditions, including if you:

  • Have heart problems
  • Have liver problems
  • Have a history of adrenal problems
  • Have a history of pituitary problems
  • Are receiving any other treatment for prostate cancer
  • Are pregnant or plan to become pregnant. ZYTIGA® can cause harm to your unborn baby and loss of pregnancy (miscarriage). Females who are or may become pregnant should not handle ZYTIGA® uncoated tablets or other ZYTIGA® tablets if broken, crushed, or damaged without protection, such as gloves
  • Have a partner who is pregnant or may become pregnant
    • Males who have female partners who are able to become pregnant should use effective birth control (contraception) during treatment with ZYTIGA® and for 3 weeks after the last dose of ZYTIGA®
  • Are breastfeeding or plan to breastfeed. It is not known if ZYTIGA® passes into your breast milk

Tell your healthcare provider about all the medicines you take or treatments you receive including prescription and over-the-counter medicines, vitamins, and herbal supplements. ZYTIGA® can interact with many other medicines.

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 change or stop taking your prescribed dose of ZYTIGA® or prednisone without talking to your healthcare provider first
  • Take ZYTIGA® on an empty stomach, at least 1 hour before or at least 2 hours after a meal. 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
  • Swallow ZYTIGA® tablets whole. Do not crush or chew tablets
  • Take ZYTIGA® tablets with water
  • 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
  • Your healthcare provider will do blood tests to check for side effects

What are the possible side effects of ZYTIGA®?

ZYTIGA® may cause serious side effects including:

  • High blood pressure (hypertension), low blood potassium levels (hypokalemia), fluid retention (edema), and irregular heartbeats can happen during treatment with ZYTIGA®. This can be life-threatening. To decrease the chance of this happening, you must take prednisone with ZYTIGA® exactly as your healthcare provider tells you. Your healthcare provider will check your blood pressure, do blood tests to check your potassium levels, and check for any signs and symptoms of fluid retention every month during treatment with ZYTIGA®
  • Tell your healthcare provider if you get any of the following symptoms:
    • Dizziness
    • Fast or irregular 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 tests. Your healthcare provider will do blood tests to check your liver before treatment with ZYTIGA® and during treatment with ZYTIGA®. Liver failure may occur, which can lead to death. Tell your healthcare provider if you notice any of the following changes:
    • Yellowing of the skin or eyes
    • Darkening of the urine
    • Severe nausea or vomiting
  • Increased risk of bone fracture and death when ZYTIGA® and prednisone or prednisolone is used in combination with a type of radiation called radium Ra 223 dichloride. Tell your healthcare provider about any other treatments you are taking for prostate cancer
  • The most common side effects of ZYTIGA® include:
    • Feeling very tired
    • Joint pain
    • High blood pressure
    • Nausea
    • Swelling in your legs or feet
    • Low blood potassium levels
    • Hot flushes
    • Diarrhea
    • Vomiting
    • Infected nose, sinuses, or throat
    • Cough
    • Headache
    • Low red blood cells (anemia)
    • High blood cholesterol and triglycerides
    • High blood sugar levels
    • Certain other abnormal blood tests

ZYTIGA® may cause fertility problems in males, which may affect the ability to father children. Talk to your healthcare provider if you have concerns about fertility.

THESE ARE NOT ALL THE POSSIBLE SIDE EFFECTS OF ZYTIGA®.

ZYTIGA® can interact with 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 healthcare provider 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).

Please see the full Prescribing Information and Patient Information for ZYTIGA® and discuss any questions you have with your doctor.

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