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

Treats metastatic castration-resistant prostate cancer (prostate cancer that has already spread to other parts of the body) in patients who have received cancer treatments, such as docetaxel. This medicine is used in combination with prednisone.

Brand Name(s):

Zytiga

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• It is best to take this medicine on an empty stomach. Do not eat 2 hours before or 1 hour after taking this medicine.
• Swallow the tablets whole with water. Do not break, crush, or chew it.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

If a dose is missed:

• If you missed a dose of this medicine, take your normal dose on the following day. If more than one daily dose is missed, call your doctor right away.

How to Store and Dispose of This Medicine:

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid:

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

• Make sure your doctor knows if you are also using dextromethorphan (Benylin®), thioridazine (Mellaril®), or a steroid medicine (such as dexamethasone, prednisolone, or Medrol®). Tell your doctor if you are also using medicine to treat HIV/AIDS (such as atazanavir, indinavir, nelfinavir, ritonavir, saquinavir, Crixivan®, Fortovase®, Invirase®, Norvir®, or Viracept®), medicine to treat an infection (such as clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole, Biaxin®, Ketek®, Nizoral®, or Sporanox®), medicine to treat tuberculosis (such as rifampin, rifabutin, rifapentine, Mycobutin®, Priftin®, Rifadin®, or Rimactane®), medicine to treat seizures (such as carbamazepine, phenobarbital, phenytoin, Dilantin®, Luminal®, or Tegretol®), or medicine to treat depression (such as nefazodone, Serzone®).

Warnings While Using This Medicine:

• Pregnant women or women who may become pregnant should not handle or touch the tablets without protection (such as gloves). This medicine may also cause birth defects if the father is using it when his sexual partner becomes pregnant. You must use a condom and another effective method of birth control during and for 1 week after the last dose of abiraterone. If a pregnancy occurs while you are using this medicine, tell your doctor right away.
• Make sure your doctor knows if you have a recent heart attack, heart or blood vessel disease, heart failure, heart rhythm problems, high blood pressure, or low potassium in the blood. Tell your doctor if you liver disease or a history of adrenal problems.
• Do not interrupt or stop using this medicine together with prednisone without asking your doctor. This may increase your risk of having adrenal gland problems. Talk to your doctor if you have more than one of these symptoms while you are using this medicine: darkening of the skin; diarrhea; dizziness; fainting; loss of appetite; mental depression; nausea; skin rash; unusual tiredness or weakness; or vomiting.
• Stop using this medicine and check with your doctor right away if you have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. Blood tests will be needed to check for unwanted effects.
• You will also need to have your blood pressure measured before starting this medicine and while you are using it. If you notice any change to your recommended blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.

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
• Change in how much or how often you urinate, difficult or painful urination, or need to get up at night to urinate.
• Chest pain.
• Dark-colored urine or pale stools.
• Dry mouth, increased thirst, or muscle cramps.
• Fast, slow, pounding, or uneven heartbeat.
• Nausea, vomiting, loss of appetite, or pain in your upper stomach.
• Rapid weight gain.
• Swelling in your hands, ankles, or feet.
• Yellowing of your skin or the whites of your eyes.

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

• Cough, runny or stuffy nose, or sore throat.
• Diarrhea, heartburn, or stomach pain or upset.
• Muscle, joint, or bone pain.
• 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