"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"...
(ex TAN dee)
What is XTANDI?
XTANDI is a prescription medicine used to treat men with prostate cancer that no longer responds to a medical or surgical treatment that lowers testosterone and that has spread to other parts of the body.
It is not known if XTANDI is safe and effective in children.
Who should not take XTANDI?
XTANDI is not for use in women.
Do not take XTANDI if you are pregnant or may become pregnant. XTANDI can harm your unborn baby.
What should I tell my healthcare provider before taking XTANDI?
Before you take XTANDI, tell your healthcare provider if you:
- have a history of seizures, brain injury, stroke, or brain tumors
- have any other medical conditions
- have a partner who is pregnant or may become pregnant. Men who are sexually active with a pregnant woman must use a condom during and for 3 months after treatment with XTANDI. If your sexual partner may become pregnant, a condom and another form of effective birth control must be used during and for 3 months after treatment. Talk with your healthcare provider if you have questions about birth control. See “Who should not take XTANDI?”
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. XTANDI may affect the way other medicines work, and other medicines may affect how XTANDI works.
You should not start or stop any medicine before you talk with the healthcare provider that prescribed XTANDI.
Know the medicines you take. Keep a list of them with you to show your healthcare provider and pharmacist when you get a new medicine.
How should I take XTANDI?
- Take XTANDI exactly as your healthcare provider tells you.
- Take your prescribed dose of XTANDI one time a day, at the same time each day.
- Your healthcare provider may change your dose if needed.
- Do not change or stop taking your prescribed dose of XTANDI without talking with your healthcare provider first.
- XTANDI can be taken with or without food.
- Swallow XTANDI capsules whole. Do not chew, dissolve, or open the capsules.
- If you miss a dose of XTANDI, take your prescribed dose as soon as you remember that day. If you miss your daily dose, take your prescribed dose at your regular time the next day. Do not take more than your prescribed dose of XTANDI in one day.
If you take too much XTANDI, call your healthcare provider or go to the nearest emergency room right away. You may have an increased risk of seizure if you take too much XTANDI.
What are the possible side effects of XTANDI?
XTANDI may cause serious side effects including:
- Seizure. If you take XTANDI you may be at risk of having a seizure. You should avoid activities where a sudden loss of consciousness could cause serious harm to yourself or others. Tell your healthcare provider right away if you have loss of consciousness or seizure. Your healthcare provider will stop XTANDI if you have a seizure during treatment.
- Posterior Reversible Encephalopathy Syndrome (PRES). If you take XTANDI you may be at risk of developing a condition involving the brain called PRES. Tell your healthcare provider right away if you have a seizure or quickly worsening symptoms such as headache, decreased alertness, confusion, reduced eyesight, blurred vision or other visual problems. Your healthcare provider will do a test to check for PRES. Your healthcare provider will stop XTANDI if you develop PRES.
The most common side effects of XTANDI include:
- weakness or feeling more tired than usual
- back pain
- decreased appetite
- joint pain
- hot flashes
- upper respiratory tract infection
- swelling in your hands, arms, legs, or feet
- shortness of breath
- muscle and bone pain
- weight loss
- high blood pressure
- a feeling that you or things around you are moving or spinning (vertigo)
XTANDI may cause infections, falls and injuries from falls. Tell your healthcare provider if you have signs or symptoms of an infection or if you fall.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of XTANDI. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store XTANDI?
- Store XTANDI between 68°F to 77°F (20°C to 25°C).
- Keep XTANDI capsules dry and in a tightly closed container.
Keep XTANDI and all medicines out of the reach of children.
General information about XTANDI.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use XTANDI for a condition for which it was not prescribed. Do not give XTANDI to other people, even if they have the same symptoms that you have. It may harm them.
This Patient Information leaflet summarizes the most important information about XTANDI. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about XTANDI that is written for health professionals.
For more information go to www.Xtandi.com or call 1-800-727-7003.
What are the ingredients in XTANDI?
Active ingredient: enzalutamide
Inactive ingredients: caprylocaproyl polyoxylglycerides, butylated hydroxyanisole, butylated hydroxytoluene, gelatin, sorbitol sorbitan solution, glycerin, purified water, titanium dioxide, black iron oxide
Last reviewed on RxList: 10/16/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Xtandi Information
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.
Get the latest treatment options.