NEW FDA APPROVAL

NEW
FDA APPROVAL

XTANDI is now approved to treat another form of advanced prostate cancer.

XTANDI is now approved to treat men with prostate cancer that no longer responds to treatment that lowers testosterone and has not spread to other parts of the body. This is also known as non-metastatic castration-resistant prostate cancer (CRPC).

Speak with your doctor for more information.

XTANDI is also proven to treat men with advanced prostate cancer that:

No longer responds to treatment that lowers testosterone

Has spread to other parts of the body

This is also known as metastatic castration-resistant prostate cancer.

Learn more

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important safety information and indication

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. It is not known if XTANDI is safe and effective in females or children.

Important Safety Information

What should I tell my doctor before taking XTANDI?

Tell your doctor about all your medical conditions, including if you:

Have a history of seizures, brain injury, stroke, or brain tumors.
Have a history of heart disease, have high blood pressure or abnormal amounts of fat or cholesterol in your blood (dyslipidemia).
Are pregnant or plan to become pregnant. XTANDI can cause harm to your unborn baby and loss of pregnancy (miscarriage). XTANDI should not be handled by females who are or may become pregnant.
Have a partner who is pregnant or may become pregnant.
- Males who have female partners who are able to become pregnant should use effective birth control during treatment with XTANDI and for 3 months after the last dose.
- Males must use a condom during sex with a pregnant female.
Are breastfeeding or plan to breastfeed. It is not known if XTANDI passes into your breast milk.
Take other medicines. XTANDI may affect the way other medicines work, and other medicines may affect how XTANDI works. These include prescription and over-the-counter medicines, vitamins, and herbal supplements. Do not start or stop any medicine without talking to your doctor.

How should I take XTANDI?

Take XTANDI exactly as your doctor tells you. Take your prescribed dose once a day, at the same time each day. Swallow XTANDI capsules whole. Do not chew, dissolve, or open the XTANDI capsules. XTANDI can be taken with or without food. Your doctor may change your dose if needed.
If you miss a dose of XTANDI: Take your prescribed dose as soon as you remember that day. If you miss a daily dose, take XTANDI at your regular time the next day. Do not take more than your prescribed dose in one day.
If you take too much XTANDI: Call your doctor or go to the nearest emergency room right away. Taking too much XTANDI may increase your risk of having a seizure.
Do not change or stop taking your prescribed dose of XTANDI without talking with your doctor first.
If you are receiving gonadotropin-releasing hormone (GnRH) therapy, you should continue with this treatment while taking XTANDI unless you have had surgery to lower the amount of testosterone in your body (surgical castration).
XTANDI should not be handled by people other than you or your caregivers, and especially not by females who are or may become pregnant.

What are the possible side effects of XTANDI?

XTANDI may cause serious side effects including:

Seizure.Seizure. If you take XTANDI, you may be at risk of having a seizure. Avoid activities where a sudden loss of consciousness (fainting) could seriously harm you or someone else. Tell your doctor right away if you lose consciousness or have a seizure.
Posterior Reversible Encephalopathy Syndrome (PRES).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 doctor 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 doctor will do a test to check for PRES.
Allergic Reactions. Allergic reactions have happened in people who take XTANDI. Stop taking XTANDI and get medical help right away if you develop swelling of the face, tongue, lip or throat.
Heart Disease. Blockage of the arteries in the heart (ischemic heart disease) that can lead to death has happened in some people during treatment with XTANDI. Your doctor will monitor you for signs and symptoms of heart problems during your treatment. Call your doctor or go to the emergency room right away if you get chest pain or discomfort at rest or with activity or shortness of breath during your treatment with XTANDI.
Falls and fractures. XTANDI treatment may increase your risk for falls and fractures. Falls were not caused by loss of consciousness or seizures. Your doctor will monitor your risks for falls and fractures during treatment with XTANDI.

Your doctor will stop treatment with XTANDI if you have serious side effects.

The most common side effects of XTANDI include:

Weakness or feeling more tired than usual
Decreased appetite
Hot flashes
Joint pain
Dizziness
A feeling that you or things around you are moving or spinning (vertigo)
High blood pressure
Headache
Weight loss

XTANDI may cause fertility problems in males, which may affect the ability to father children. Talk to your doctor if you have concerns about fertility.

These are not all the possible side effects of XTANDI. For more information, talk to your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-10881-800-FDA-1088 or www.fda.gov/medwatch.

What is XTANDI?

XTANDI is a prescription medicine used to treat men with prostate cancer that no longer reponds to a medical or surgical treatment that lowers testosterone. It is not known if XTANDI is safe and effective in females or children.

Please see the Full Prescribing Information for complete prescribing information.