What is the most important information I should know about abiraterone?
You should not use this medicine if you have severe liver disease.
Abiraterone tablets should not be handled by a woman who is pregnant or who may become pregnant. This medicine can harm an unborn baby or cause birth defects.
What is abiraterone?
Abiraterone works by reducing androgen production in the body. Androgens are male hormones that can promote tumor growth in the prostate gland.
Abiraterone is used together with prednisone to treat prostate cancer that has spread to other parts of the body. This medicine is used in men whose prostate cancer cannot be treated with surgery or other medicines.
Abiraterone may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking abiraterone?
You should not use abiraterone if you are allergic to it, or if you have ever had:
To make sure abiraterone is safe for you, tell your doctor if you have:
- liver disease;
- heart disease, high blood pressure;
- problems with your adrenal gland or pituitary gland;
- low levels of potassium in your blood;
- fluid retention;
- a heart attack; or
- if you take medicine to treat seizures, tuberculosis, HIV or AIDS.
While you are taking abiraterone and for at least 1 week after your treatment ends:
- If your sexual partner is pregnant--Use a condom to prevent transfer of this medication to her.
- If your sexual partner could become pregnant--Use a condom plus another form of effective birth control to prevent pregnancy.
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.
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.
Abiraterone is not approved for use by anyone younger than 18 years old.
How should I take abiraterone?
Abiraterone is usually taken once per day while also taking prednisone two times per day. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Your prednisone dosage needs may change if you have surgery, are ill, or are under stress. Do not change your medication dose or schedule without your doctor's advice.
Take abiraterone on an empty stomach. Do not eat anything for at least 2 hours before you take abiraterone and for at least 1 hour after you have taken the medicine.
Do not crush, chew, or break an abiraterone tablet. Swallow it whole with a full glass of water.
Your blood pressure will need to be checked often, and you may need frequent blood tests at your doctor's office.
You should not stop using abiraterone or prednisone suddenly. Follow your doctor's instructions about tapering your prednisone dose.
Store at room temperature away from moisture and heat.
Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.
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?
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.
Avoid taking an herbal supplement containing St. John's wort at the same time you are taking abiraterone.
This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.
What are the possible side effects of abiraterone?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using abiraterone and call your doctor at once if you have:
- swelling in your ankles or feet, pain in your legs;
- pain or burning when you urinate;
-
dangerously high blood pressure --severe headache, blurred vision, pounding in your neck or ears, nosebleed, anxiety, severe chest pain, shortness of breath;
-
high blood sugar --increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss;
-
liver problems --nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
-
low potassium --confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling; or
-
signs of low adrenal gland hormones --worsening tiredness or muscle weakness, feeling light-headed, nausea, vomiting, loss of appetite, diarrhea, and weight loss.
Common side effects may include:
- vomiting, diarrhea, painful or difficult urination;
- swelling;
- feeling weak, feeling very hot;
- joint pain or swelling;
- bruising; or
- cough, feeling short of breath.
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?
Other drugs may interact with abiraterone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
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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