Download IconFull Prescribing Information

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.

Help With Side Effects

Tips to discuss with your doctor

These tips come from organizations that focus on supporting people with cancer. The tips have not been studied with XTANDI; however, they may be able to help with prostate cancer side effects such as: weakness, feeling tired, pain, or hot flashes. You should always talk with your healthcare team before deciding if any of these tips are right for you.

Weakness

Drink plenty of liquids, especially water.
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Your body needs water to do its work. Talk to your healthcare team about how much water to drink each day.

Stay active.
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Try going for short walks or doing light stretching exercises. Talk with your healthcare team about other types of exercises that may help you feel better.

Get a good night’s sleep.
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If you feel tired during the day, it’s okay to rest and take a nap to help increase your energy level. Try to keep your naps short and early in the day so they don’t interfere with nighttime sleep.

Feeling tired

Try to exercise.
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Exercise can help you feel better both physically and mentally. It may also help increase your energy level. If you decide to exercise, make sure to check with your doctor about healthy ways to add it to your routine.

Focus on relaxing.
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If you’re feeling stressed, it might help if you talk to other men living with advanced prostate cancer. Support groups can be a great place to start. You can also try doing things that can help you relax but that require little energy, like reading, listening to music, or meditating.

Stick with a consistent sleep schedule.
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Try to sleep 7 to 8 hours each night. Also, try to limit your naps to under 30 minutes. If you can, avoid foods and drinks high in caffeine at night.

Talk with your healthcare team or dietitian about managing your diet.
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Work with them to create an eating plan that includes the right amount of nutrients and liquids your body needs. This includes foods you should be eating and foods you may want to avoid.

Pain

Keep a pain journal to share with your healthcare team.
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Keeping a journal can help you keep track of exactly when you felt the pain, how long it lasted, and what you were doing when the pain started. Try to rate the pain on a scale of 0 to 10, with 10 being the highest. If you are having pain, make sure to talk with your healthcare team to find ways to help you.

Try using warm compresses.
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Using warm compresses may be able to help reduce pain, especially if it’s muscle-related.

Try relaxation techniques.
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Try doing things to help you relax, such as breathing exercises and meditation, to help reduce tension and pain.

Talk with your doctor about medicines that may help reduce pain.
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He or she may prescribe certain medicines to help reduce your pain.

Hot flashes

Try to lower your body’s temperature.
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As a start, try wearing loose-fitting cotton clothing. You might also want to keep a fan running and your windows open—this can help circulate the air throughout your home.

Try relaxation techniques.
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If you can, try taking slow, deep breaths to help you relax.

Talk with your doctor or nurse about any side effects you experience and ways to help manage them.

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

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. 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). 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.

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

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. 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.

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

important safety information and indication

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.