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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. (This is a type of advanced prostate cancer.)

XTANDI support: 1-855-898-2634

How XTANDI May Help

How XTANDI was studied

A study of 1,717 men with advanced prostate cancer compared men taking XTANDI with men not taking XTANDI.

All of the men in this study:

  • Had prostate cancer that had spread to other parts of the body
  • Had not received chemotherapy
  • Were no longer responding to a medical or surgical treatment to lower testosterone
  • Received hormone injections during the study

How XTANDI was shown to help

XTANDI slowed the progression
of advanced prostate cancer
83% Lower Chance
DURING THE STUDY

Men taking XTANDI had an 83% lower chance of their cancer progressing

compared with men not taking XTANDI

Also in the study, 86% of men taking XTANDI did not see their cancer progress compared
with 60% of men not taking XTANDI. Progression was defined as the cancer getting worse, as measured by scans, or if the patient died for any reason.

XTANDI helped men live longer
Median Overall Survival
DURING THE STUDY

Men taking XTANDI lived longer

than men not taking XTANDI

The median overall survival was 35 months for men taking XTANDI vs 31 months for men not taking XTANDI.

The median is not the average, but the middle of a set of numbers.

More about the study
XTANDI delayed the median time before men began chemotherapy
Median Time Before Beginning Chemotherapy

During this study, XTANDI delayed the median time before men began chemotherapy by 28 months compared with 11 months for men not taking XTANDI.

Select Safety Information

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.

 
XTANDI was also studied to understand how well it slows prostate cancer progression compared with bicalutamide

A study of 375 men with advanced prostate cancer compared 184 men who were taking XTANDI with 191 men who were taking bicalutamide.

All of the men in this study:

  • Had prostate cancer that had spread to other parts of the body
  • Had not received chemotherapy
  • Were no longer responding to a medical or surgical treatment to lower testosterone
  • Received hormone injections during the study
During this study, XTANDI:

Slowed the progression of advanced prostate cancer compared with bicalutamide

Men taking XTANDI had a 40% lower chance of their cancer progressing than men taking bicalutamide.*

*In this study, progression was defined as the cancer getting worse, as measured by scans, or if the patient died for any reason.

Select Safety Information

If you take XTANDI you may be at risk of developing a condition involving the brain called Posterior Reversible Encephalopathy Syndrome (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.

Who is XTANDI for?

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. (This is a type of advanced prostate cancer.)

Important Safety Information

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

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 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?"
  • Take any other medicines, 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.

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.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).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, constipation, joint pain, diarrhea, hot flashes, upper respiratory tract infection, swelling in your hands, arms, legs, or feet, shortness of breath, muscle and bone pain, weight loss, headache, high blood pressure, dizziness, and 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. Call your healthcare provider 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.

Please see the Full Prescribing Information for complete prescribing information.

Who is XTANDI for?

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. (This is a type of advanced prostate cancer.)

Important Safety Information

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

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 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?"
  • Take any other medicines, 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.

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.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).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, constipation, joint pain, diarrhea, hot flashes, upper respiratory tract infection, swelling in your hands, arms, legs, or feet, shortness of breath, muscle and bone pain, weight loss, headache, high blood pressure, dizziness, and 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. Call your healthcare provider 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.

Please see the Full Prescribing Information for complete prescribing information.

Important Safety Information

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

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 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?"
  • Take any other medicines, 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.

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.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).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, constipation, joint pain, diarrhea, hot flashes, upper respiratory tract infection, swelling in your hands, arms, legs, or feet, shortness of breath, muscle and bone pain, weight loss, headache, high blood pressure, dizziness, and 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. Call your healthcare provider 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.

Please see the Full Prescribing Information for complete prescribing information.