What is the most important information I should know about abiraterone?
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Although abiraterone is not for use by women, this medicine can harm an unborn baby or cause birth defects. Abiraterone tablets should not be handled by a woman who is pregnant or who may become pregnant. If this cannot be avoided, the woman should wear latex gloves. |
While you are taking abiraterone and for at least 1 week after your treatment ends: Use a condom to prevent transfer of this medication to your sexual partner if she is pregnant. Use a condom plus another form of effective birth control if your sexual partner could become pregnant.
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You should not use abiraterone if you are allergic to it, if you are pregnant, or if you have severe liver disease. |
Before you take abiraterone, tell your doctor if you have liver disease, low levels of potassium in your blood, any type of infection, high blood pressure, congestive heart failure, or a history of heart disease, fluid retention, recent heart attack, or problems with your adrenal gland or pituitary gland.
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Take abiraterone on an empty stomach. Avoid eating for at least 2 hours before you take abiraterone and for at least 1 hour after your dose. Food can increase the amount of abiraterone your body absorbs. |
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Your blood pressure will need to be checked often. You will also need regular medical tests to be sure this medication is not causing harmful effects. Visit your doctor regularly. |
What is abiraterone?
Abiraterone works in the body by preventing the actions of androgens (male hormones).
Abiraterone is used together with prednisone to treat prostate cancer that has spread to other parts of the body.
Abiraterone is usually given after other cancer medications and treatments have been tried.
Abiraterone may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking abiraterone?
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You should not use abiraterone if you are allergic to it, if you are pregnant, or if you have severe liver disease. |
To make sure you can safely take abiraterone, tell your doctor if you have any of these other conditions:
- liver disease;
- low levels of potassium in your blood;
- any type of infection;
- high blood pressure;
- congestive heart failure;
- a history of heart disease, fluid retention, or recent heart attack; or
- a history of problems with your adrenal gland or pituitary gland.
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FDA pregnancy category X. Although abiraterone is not for use by women, this medication can harm an unborn baby or cause birth defects. Abiraterone tablets should not be handled by a woman who is pregnant or who may become pregnant. If this cannot be avoided, the woman should wear latex gloves. |
While you are taking abiraterone and for at least 1 week after your treatment ends: Use a condom to prevent transfer of this medication to your sexual partner if she is pregnant. Use a condom plus another form of effective birth control if your sexual partner could become pregnant.
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It is not known whether abiraterone passes into breast milk or if it could harm a nursing baby. Abiraterone should not be used by a woman who is breast-feeding a baby. |
What happens if I miss a dose?
Skip the missed dose and take the medicine the following day on an empty stomach (no food for at least 2 hours before or 1 hour after you take abiraterone). Do not take extra medicine to make up the missed dose.
Call your doctor for instructions if you miss more than one dose of abiraterone.
What happens if I overdose?
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Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. |
What should I avoid while taking abiraterone?
Avoid eating for at least 2 hours before you take abiraterone and for at least 1 hour after your dose. Food can increase the amount of abiraterone your body absorbs.
What are the possible side effects of abiraterone?
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Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. |
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Stop using abiraterone and call your doctor at once if you have a serious side effect such as: |
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- swelling in your ankles or feet, feeling short of breath (even with mild exertion);
- fast or uneven heart rate;
- pain or burning when you urinate;
- low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);
- extreme weakness, feeling like you might pass out;
- nausea, vomiting, ongoing diarrhea, weight loss;
- craving for salty foods; or
- pale skin, dark or patchy skin color.
Less serious side effects may include:
- mild diarrhea, heartburn, upset stomach;
- increased urination (especially at night);
- sweating, feeling very hot;
- cold symptoms such as stuffy nose, sneezing, sore throat, cough; or
- swelling or discomfort in your muscles or joints.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect abiraterone?
Tell your doctor about all other medicines you use, especially:
- thioridazine (Mellaril); or
- cough medicine such as dextromethorphan (Delsym, Robitussin Maximum Strength, Vicks 44, and others).
This list is not complete and other drugs may interact with abiraterone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
Where can I get more information?
Your pharmacist can provide more information about abiraterone.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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