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.

Privacy Statement

Astellas Pharma US, Inc. (Astellas) and Pfizer Inc. respect the privacy of visitors to our online sites. Astellas and Pfizer Inc. will only collect your personally identifiable information, such as your name, address, telephone number, or e-mail address, when you provide it to us at this web site. Astellas and Pfizer Inc. and/or the companies we hire will use this information to comply with your request for information or as otherwise disclosed to you on the web page when you submit your information to us. From time to time, we may refer to this information to better understand your needs and how we can improve our products and services. We may use this information to contact you. We will not sell or otherwise transfer the personally identifiable information you provide to us at this web site to any third parties for their own use unless we tell you when you submit your information to us that we intend to do so.

Like many web sites, this Astellas and Pfizer Inc. web site uses a technology called "cookies". A cookie is a small text file that a web server gives your browser to store on your computer when you access a web site. Cookies are capable of storing many types of data and may be placed on your browser by Astellas and Pfizer Inc. or by a third party. Cookies may be used for a variety of purposes on this web site:

  • This site sets cookies that keep you from having to enter a password more than once during visits to one or more of our sites.
  • We also use cookies to help us analyze usage of our sites and traffic among our sites more accurately and to provide you with information of interest to you. For example, cookies are used on this site to record the total number of hits received on the site and web pages.
  • Cookies also allow Astellas and Pfizer Inc. to determine whether you came to this site from another Astellas and Pfizer Inc. site or from an advertising banner or link on a non-Astellas or Pfizer Inc. web site, so that we can, for example, measure the effectiveness of the links among our sites and the effectiveness of our advertising on non-Astellas or Pfizer Inc. web sites.
  • Similarly, cookies allow us to determine whether you register on or visit any of our web sites, which enables us to analyze how particular users use our sites and whether registered and unregistered users of our web sites use our sites differently.
  • Cookies also allow us to maintain information about how particular visitors use our family of sites, which enables us to better provide such visitors with information relevant to their interests. This may include using information about your use of our sites in conjunction with personally identifiable information that you have volunteered to us on one of our sites.

This is not an exhaustive list of all uses of cookies on Astellas or Pfizer Inc. web sites. In all cases in which cookies are used, however, neither Astellas, Pfizer Inc., nor any third party will use the cookie to collect personally identifiable information from our site unless you voluntarily agree to enter the information. Most web browsers are set up to accept cookies. You can, however, reset your browser to refuse all cookies or to indicate when a cookie is being sent. Note, however, that some portions of our sites may not work properly if you refuse cookies.

In addition to cookies, Astellas or Pfizer Inc. may collect non-personally identifiable information about how you use our web sites using other analysis technologies. These analysis technologies may be provided by third parties. Information that might be collected using these technologies includes, for example, the pages you visit on our site, the paths you take within our sites and the length of time that you spend on our web sites. We use this information in the aggregate in order to better understand how to improve the quality of our web sites.

Some Astellas or Pfizer Inc. web sites use a third party advertising service to display advertising on other, non-Astellas or Pfizer Inc. web sites. In addition to placing advertisements on certain non-Astellas and Pfizer Inc. web pages, these services and/or Astellas and Pfizer Inc. may also place a segment of code called a clear pixel tag, also known as a "gif", on certain Astellas and Pfizer Inc. web pages that do not contain advertisements for the purpose of measuring the effectiveness of advertisements in bringing visitors to our web sites. Gifs may also be used with cookies to track the total number of visitors to our web site, the number of visitors to various web pages, and the domain names of our visitors' internet service providers. No personally identifiable information is collected in this process.

As is common among internet site operators, Astellas and Pfizer Inc. web sites maintain web server logs. Web servers automatically identify your computer by its IP address and collect that information in its web server logs. An IP address is a number that is automatically assigned to your computer by your internet service provider (e.g., aol, msn, earthlink) whenever you log onto the world wide web or "surf" the web. Astellas and Pfizer Inc. web server logs collect statistical data that is generated by your computer when it visits a Astellas and Pfizer Inc. web site, such as the type of web browser (e.g., Netscape, Internet Explorer) and operating system (Windows 95 or Mac OS) used to access the site, the domain name of your internet service provider, the date and time you access our site, and the pages you visit. Astellas and Pfizer Inc. web sites use this non-personally identifying web server log information for a variety of purposes. Some of these purposes include: system administration; to examine overall traffic trends on our sites; trouble-shooting; and to gather broad demographic information about users of our sites. No personally identifiable information is contained in these web server logs.

Astellas and Pfizer Inc. use technical and organizational security precautions, in order to protect your data from coincidental or deliberate manipulation, loss, destruction or access by unauthorized persons. As part of the collection and processing of personal data, all transferred information will be encrypted to prevent misuse of the data by third parties. Our security procedures are continuously revised based on new technological developments.

This Astellas and Pfizer Inc. web site is not intended or designed to attract children under the age of 13. We do not collect personally identifiable information from any person we know to be under the age of 13.

As a convenience to our visitors, Astellas and Pfizer Inc.’s sites currently contain links to a number of web sites that we believe may offer useful information. The privacy policy and provisions described here do not apply to those sites. We suggest contacting those sites directly for information on their data collection and distribution policies.

From time to time, Astellas and Pfizer Inc. may decide to modify its practices and policies, and we reserve the right to revise this Astellas and Pfizer Inc. internet privacy statement as necessary to disclose such changes in our practices and policies. Any such changes to this Astellas and Pfizer Inc. internet privacy statement will be promptly communicated on this page. Any information that you submit before the change in policy will be used by Astellas and Pfizer Inc. and/or the companies we hire in a manner that is consistent with the Astellas and Pfizer Inc. internet privacy statement in effect at the time you submitted your information. Continued use of our sites after receiving notice of a change in our privacy statement shall indicate your consent to the use of newly-submitted information in accordance with the changed, amended, or updated Astellas and Pfizer Inc. internet privacy statement.

Questions about Astellas' Internet Privacy Statement, including categories of data collection, may be directed to webmaster@us.astellas.com.

© 2018 Astellas Pharma US, Inc. All rights reserved.

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.