Abiraterone acetate Oral tablet

What is this medicine?

ABIRATERONE (a bir A ter one) blocks the effect of the male hormone called testosterone. This medicine is used for certain types of prostate cancer.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• heart disease

• high blood pressure

• history of irregular heartbeat

• liver disease

• low levels of potassium in the blood

• an unusual or allergic reaction to abiraterone, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine on an empty stomach. No food should be eaten 2 hours before and 1 hour after taking this medication. Do not take with food. Do not cut, crush, or chew this medicine. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take the next dose at your regular time. Do not take double or extra doses. If you miss more than 1 dose, tell your healthcare provider right away.

What may interact with this medicine?

• antiviral medicines for HIV or AIDS

• certain medicines for fungal infections like ketoconazole and itraconazole

• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin

• clarithromycin

• nefazodone

• rifabutin

• rifampin

• rifapentine

• telithromycin

• thioridazine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

If you are a woman, do not get pregnant while taking this medicine. If you do get pregnant, tell your doctor right away. There is a potential for serious side effects to an unborn child. Women who are pregnant or may become pregnant should not touch this medicine without wearing gloves. Men taking this medicine must use a condom when having sex with a pregnant woman during and for one week after treatment with this medicine. Men who have sex with a woman who may get pregnant must use a condom and another form of birth control during and for one week after treatment with this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• chest pain or chest tightness

• fast, irregular heartbeat

• feeling faint or lightheaded, falls

• general ill feeling or flu-like symptoms

• palpitations

• right upper belly pain

• signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine

• swelling of the ankles, feet, hands

• unusually weak or tired

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• cough

• diarrhea

• facial flushing

• increased urination

• joint pain

• muscle pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children. Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.