"The U.S. Food and Drug Administration today expanded the approved use of Zytiga (abiraterone acetate) to treat men with late-stage (metastatic) castration-resistant prostate cancer prior to receiving chemotherapy.
The FDA initially appr"...
- Clinician Information:
Zytiga Patient Information Including Side Effects
Brand Names: Zytiga
Generic Name: abiraterone (Pronunciation: A bir A te rone)
- What is abiraterone (Zytiga)?
- What are the possible side effects of abiraterone (Zytiga)?
- What is the most important information I should know about abiraterone (Zytiga)?
- What should I discuss with my healthcare provider before taking abiraterone (Zytiga)?
- How should I take abiraterone (Zytiga)?
- What happens if I miss a dose (Zytiga)?
- What happens if I overdose (Zytiga)?
- What should I avoid while taking abiraterone (Zytiga)?
- What other drugs will affect abiraterone (Zytiga)?
- Where can I get more information?
What is abiraterone (Zytiga)?
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 are the possible side effects of abiraterone (Zytiga)?
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.
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.
Read the Zytiga (abiraterone acetate tablets) Side Effects Center for a complete guide to possible side effects
What is the most important information I should know about abiraterone (Zytiga)?
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.
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.
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.
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.
Additional Zytiga Information
- Zytiga Drug Interactions Center: abiraterone oral
- Zytiga Side Effects Center
- Zytiga FDA Approved Prescribing Information including Dosage
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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