Abiraterone Acetate (a-bir-A-ter-one AS-e-tate)

Treats prostate cancer. This medicine is given with prednisone.

Brand Name(s):

Yonsa, Zytiga

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Take this medicine on an empty stomach. Do not eat food 2 hours before or 1 hour after taking this medicine.
• Swallow the tablet whole with water. Do not break, crush, or chew it.
• Your doctor may also give you other medicines (including gonadotropin-releasing hormone medicine) during treatment with abiraterone or you should have had surgical removal of the testes before using this medicine.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If you missed a dose, skip that dose and take your normal dose the following day. If you miss more than one dose, call your doctor right away.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how abiraterone works. Tell your doctor if you are using carbamazepine, dextromethorphan, phenobarbital, phenytoin, pioglitazone, repaglinide, rifabutin, rifampin, rifapentine, or thioridazine.

Warnings While Using This Medicine:

• Women who are pregnant or may become pregnant should not touch this medicine without wearing gloves.
• This medicine may cause birth defects if a man is using it when his partner becomes pregnant. Use a condom plus another form of birth control during treatment with this medicine and for 3 weeks after the last dose. Tell your doctor right away if a pregnancy occurs while you are using this medicine.
• Tell your doctor if you have liver disease, heart or blood vessel disease, high blood pressure, heart failure, heart rhythm problems, a recent heart attack, diabetes, electrolyte imbalance, or a history of adrenal problems.
• This medicine may cause the following problems:
  • High blood pressure
  • Adrenal problems
  • Liver problems
  • Increased risk of bone fractures and death when used together with radium 223 dichloride (radiation treatment)
  • Low blood sugar
• Do not stop using this medicine, even for a short time, without first asking your doctor.
• Talk with your doctor before using this medicine if you plan to have children. Some men who use this medicine have become infertile (unable to have children).
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bone pain, pain or swelling in the arms or legs without any injury
• Dark freckles, skin color changes, feeling of coldness, weakness, tiredness, weight loss
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Dry mouth, increased thirst, muscle cramps
• Fast, slow, pounding, or uneven heartbeat
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Rapid weight gain, swelling in your hands, ankles, or feet
• Shaking, trembling, sweating, faintness or lightheadedness, hunger, confusion

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, upset stomach
• Falls, bruise
• Headache
• Joint or muscle pain, weakness, or swelling
• Warmth or redness in your face, neck, arms, or upper chest

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088