Abiraterone Acetate, Micronized (a-bir-A-ter-one AS-e-tate, MYE-kroe-nized)

Treats prostate cancer. This medicine is given with methylprednisolone.

Brand Name(s):

Yonsa

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.
• Swallow the tablets whole with water. Do not crush or chew the tablets.
• Your doctor may give you other medicines (including a gonadotropin-releasing hormone) unless you had a surgery to lower the amount of testosterone in your body.
• Use only the brand of this medicine that your doctor prescribed. Different brands have different dosages and effects when taken with food.
• 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, rifabutin, rifampin, or rifapentine.

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 at least 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, high blood pressure, heart or blood vessel disease, heart failure, heart rhythm problems (including QT prolongation, torsades de pointes), a recent heart attack, or a history of adrenal problems.
• This medicine may cause the following problems:
  • High blood pressure
  • Adrenal problems
  • Liver problems
  • Increased risk for fractures, when used with a radiation treatment (radium Ra 223 dichloride)
• 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
• Bloody or cloudy urine, lower back or side pain, difficult or painful urination
• Confusion, headache, trouble breathing
• 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
• Lightheadedness, dizziness, fainting
• Rapid weight gain, swelling in your hands, ankles, or feet
• Unusual bleeding or bruising

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

• Cough
• Diarrhea, upset stomach
• 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