Potential Side Effects of ZYTIGA® (abiraterone acetate)

Potential Side Effects of ZYTIGA^®

It's important to know the potential side effects of any medication you're taking or may start to take.

ZYTIGA^® may cause serious side effects including:

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

Taking prednisone with ZYTIGA^® may help to reduce the incidence and severity of some of the potential side effects of the medication.

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. Your doctor 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:

Joint swelling or discomfort
Muscle aches
Hot flushes
Diarrhea
Urinary tract infection
Cough
Irregular heartbeat
Urinating more often than normal
Need to get up at night to urinate
Heartburn
Cold-like symptoms
Bone fractures

These are not all the possible side effects of ZYTIGA^®. For more information, ask your doctor or pharmacist.

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What is ZYTIGA^®?

ZYTIGA^® (Zye-tee-ga) 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 and who have previously received treatment with docetaxel.

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:

Have heart problems
Have liver problems
Have a history of adrenal and/or pituitary problems
Have any other medical conditions
Plan to become pregnant
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.
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. 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.
ZYTIGA^® is supplied as 250-mg tablets and the usual dose of ZYTIGA^® is four tablets taken once daily.
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^®.
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. 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:
- Joint swelling or pain
- Muscle aches
- Hot flushes
- Diarrhea
- Urinary tract infection
- Cough
- Irregular heartbeats
- Urinating more often than normal
- Need to get up at night to urinate
- Heartburn
- Cold-like symptoms
- Bone fractures
- 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).