XTANDI is a prescription medicine used to treat men with prostate cancer that:

  • no longer responds to a hormone therapy or surgical treatment to lower testosterone
  • OR

  • has spread to other parts of the body and responds to a hormone therapy or surgical treatment to lower testosterone

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

XTANDI may cause
serious side effects

Side effect; seizure icon

Seizure
If you take XTANDI, you may be at risk of having a seizure. Avoid activities where a sudden loss of consciousness could seriously harm you or someone else. Tell your doctor right away if you lose consciousness or have a seizure.

Side effect; Posterior Reversible Encephalopathy Syndrome (PRES) icon

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.

Side effect; allergic reaction icon

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.

Side effect; heart disease icon

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.

Side effect; falls & fractures icon

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.

Common side effects; icon

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

What are the most common side effects of XTANDI?

  • Weakness or feeling more tired than usual
  • Back pain
  • Hot flashes
  • Constipation
  • Joint pain
  • Decreased appetite
  • Diarrhea
  • High blood pressure

 

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-1088 or www.fda.gov/medwatch.

 

For further information, please talk to your doctor and click here to see Patient Information and Full Prescribing Information for XTANDI.

 

Important Safety Information

Important Safety Information and Indication

What is XTANDI?

XTANDI is a prescription medicine used to treat men with prostate cancer that:

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:

How should I take XTANDI?

What are the possible side effects of XTANDI?

XTANDI may cause serious side effects including:

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

The most common side effects of XTANDI include:

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-1088 or www.fda.gov/medwatch.

For further information, please talk to your doctor and click here for Patient Information and Full Prescribing Information for XTANDI.

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