XTANDI 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.

You may stop receiving future communications from this web site, or any further Astellas or Pfizer Inc. communications, at any time. To cancel further communications, please complete the following to unsubscribe.

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.

© 2021 Astellas Pharma US, Inc. and Pfizer Inc. All rights reserved.

Important Safety Information

Warnings and Precautions

Seizure occurred in 0.5% of patients receiving XTANDI in seven randomized clinical trials. In a study of patients with predisposing factors for seizure, 2.2% of XTANDI-treated patients experienced a seizure. It is unknown whether anti-epileptic medications will prevent seizures with XTANDI. Patients in the study had one or more of the following predisposing factors: use of medications that may lower the seizure threshold, history of traumatic brain or head injury, history of cerebrovascular accident or transient ischemic attack, and Alzheimer’s disease, meningioma, or leptomeningeal disease from prostate cancer, unexplained loss of consciousness within the last 12 months, history of seizure, presence of a space occupying lesion of the brain, history of arteriovenous malformation, or history of brain infection. Advise patients of the risk of developing a seizure while taking XTANDI and of engaging in any activity where sudden loss of consciousness could cause serious harm to themselves or others. Permanently discontinue XTANDI in patients who develop a seizure during treatment.

Posterior Reversible Encephalopathy Syndrome (PRES) There have been reports of PRES in patients receiving XTANDI. PRES is a neurological disorder that can present with rapidly evolving symptoms including seizure, headache, lethargy, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably MRI. Discontinue XTANDI in patients who develop PRES.

Hypersensitivity reactions, including edema of the face (0.5%), tongue (0.1%), or lip (0.1%) have been observed with XTANDI in seven randomized clinical trials. Pharyngeal edema has been reported in post-marketing cases. Advise patients who experience any symptoms of hypersensitivity to temporarily discontinue XTANDI and promptly seek medical care. Permanently discontinue XTANDI for serious hypersensitivity reactions.

Ischemic Heart Disease In the combined data of four randomized, placebo-controlled clinical studies, ischemic heart disease occurred more commonly in patients on the XTANDI arm compared to patients on the placebo arm (2.9% vs 1.3%). Grade 3-4 ischemic events occurred in 1.4% of patients on XTANDI versus 0.7% on placebo. Ischemic events led to death in 0.4% of patients on XTANDI compared to 0.1% on placebo. Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue XTANDI for Grade 3-4 ischemic heart disease.

Falls and Fractures occurred in patients receiving XTANDI. Evaluate patients for fracture and fall risk. Monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone-targeted agents. In the combined data of four randomized, placebo-controlled clinical studies, falls occurred in 11% of patients treated with XTANDI compared to 4% of patients treated with placebo. Fractures occurred in 10% of patients treated with XTANDI and in 4% of patients treated with placebo.

Embryo-Fetal Toxicity The safety and efficacy of XTANDI have not been established in females. XTANDI can cause fetal harm and loss of pregnancy when administered to a pregnant female. Advise males with female partners of reproductive potential to use effective contraception during treatment with XTANDI and for 3 months after the last dose of XTANDI.

Adverse Reactions (ARs)

In the data from the four randomized placebo-controlled trials, the most common ARs ( 10%) that occurred more frequently ( 2% over placebo) in XTANDI-treated patients were asthenia/fatigue, back pain, hot flush, constipation, arthralgia, decreased appetite, diarrhea, and hypertension. In the bicalutamide-controlled study, the most common ARs ( 10%) reported in XTANDI-treated patients were asthenia/fatigue, back pain, musculoskeletal pain, hot flush, hypertension, nausea, constipation, diarrhea, upper respiratory tract infection, and weight loss.

In AFFIRM, the placebo-controlled study of metastatic CRPC (mCRPC) patients who previously received docetaxel, Grade 3 and higher ARs were reported among 47% of XTANDI-treated patients. Discontinuations due to adverse events (AEs) were reported for 16% of XTANDI-treated patients. In PREVAIL, the placebo-controlled study of chemotherapy-naive mCRPC patients, Grade 3-4 ARs were reported in 44% of XTANDI patients and 37% of placebo patients. Discontinuations due to AEs were reported for 6% of XTANDI-treated patients. In TERRAIN, the bicalutamide-controlled study of chemotherapy-naive mCRPC patients, Grade 3-4 ARs were reported in 39% of XTANDI patients and 38% of bicalutamide patients. Discontinuations with an AE as the primary reason were reported for 8% of XTANDI patients and 6% of bicalutamide patients.

In PROSPER, the placebo-controlled study of non-metastatic CRPC (nmCRPC) patients, Grade 3 or higher ARs were reported in 31% of XTANDI patients and 23% of placebo patients. Discontinuations with an AE as the primary reason were reported for 9% of XTANDI patients and 6% of placebo patients.

In ARCHES, the placebo-controlled study of metastatic CSPC (mCSPC) patients, Grade 3 or higher AEs were reported in 24% of XTANDI-treated patients. Permanent discontinuation due to AEs as the primary reason was reported in 5% of XTANDI patients and 4% of placebo patients.

Lab Abnormalities: Lab abnormalities that occurred in 5% of patients, and more frequently (> 2%) in the XTANDI arm compared to placebo in the pooled, randomized, placebo-controlled studies are neutrophil count decreased, white blood cell decreased, hyperglycemia, hypermagnesemia, hyponatremia, and hypercalcemia.

Hypertension: In the combined data from four randomized placebo-controlled clinical trials, hypertension was reported in 12% of XTANDI patients and 5% of placebo patients. Hypertension led to study discontinuation in < 1% of patients in each arm.

Drug Interactions

Effect of Other Drugs on XTANDI Avoid coadministration with strong CYP2C8 inhibitors. If coadministration cannot be avoided, reduce the dosage of XTANDI.

Avoid coadministration with strong CYP3A4 inducers. If coadministration cannot be avoided, increase the dosage of XTANDI.

Effect of XTANDI on Other Drugs Avoid coadministration with certain CYP3A4, CYP2C9, and CYP2C19 substrates for which minimal decrease in concentration may lead to therapeutic failure of the substrate. If coadministration cannot be avoided, increase the dosage of these substrates in accordance with their Prescribing Information. In cases where active metabolites are formed, there may be increased exposure to the active metabolites.

Indications

XTANDI (enzalutamide) is indicated for the treatment of patients with:

  • castration-resistant prostate cancer (CRPC)
  • metastatic castration-sensitive prostate cancer (mCSPC)

Please see Full Prescribing Information.

Important Safety Information

Warnings and Precautions

Seizure occurred in 0.5% of patients receiving XTANDI in seven randomized clinical trials. In a study of patients with predisposing factors for seizure, 2.2% of XTANDI-treated patients experienced a seizure. It is unknown whether anti-epileptic medications will prevent seizures with XTANDI. Patients in the study had one or more of the following predisposing factors: use of medications that may lower the seizure threshold, history of traumatic brain or head injury, history of cerebrovascular accident or transient ischemic attack, and Alzheimer’s disease, meningioma, or leptomeningeal disease from prostate cancer, unexplained loss of consciousness within the last 12 months, history of seizure, presence of a space occupying lesion of the brain, history of arteriovenous malformation, or history of brain infection. Advise patients of the risk of developing a seizure while taking XTANDI and of engaging in any activity where sudden loss of consciousness could cause serious harm to themselves or others. Permanently discontinue XTANDI in patients who develop a seizure during treatment.

Posterior Reversible Encephalopathy Syndrome (PRES) There have been reports of PRES in patients receiving XTANDI. PRES is a neurological disorder that can present with rapidly evolving symptoms including seizure, headache, lethargy, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably MRI. Discontinue XTANDI in patients who develop PRES.

Hypersensitivity reactions, including edema of the face (0.5%), tongue (0.1%), or lip (0.1%) have been observed with XTANDI in seven randomized clinical trials. Pharyngeal edema has been reported in post-marketing cases. Advise patients who experience any symptoms of hypersensitivity to temporarily discontinue XTANDI and promptly seek medical care. Permanently discontinue XTANDI for serious hypersensitivity reactions.

Ischemic Heart Disease In the combined data of four randomized, placebo-controlled clinical studies, ischemic heart disease occurred more commonly in patients on the XTANDI arm compared to patients on the placebo arm (2.9% vs 1.3%). Grade 3-4 ischemic events occurred in 1.4% of patients on XTANDI versus 0.7% on placebo. Ischemic events led to death in 0.4% of patients on XTANDI compared to 0.1% on placebo. Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue XTANDI for Grade 3-4 ischemic heart disease.

Falls and Fractures occurred in patients receiving XTANDI. Evaluate patients for fracture and fall risk. Monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone-targeted agents. In the combined data of four randomized, placebo-controlled clinical studies, falls occurred in 11% of patients treated with XTANDI compared to 4% of patients treated with placebo. Fractures occurred in 10% of patients treated with XTANDI and in 4% of patients treated with placebo.

Embryo-Fetal Toxicity The safety and efficacy of XTANDI have not been established in females. XTANDI can cause fetal harm and loss of pregnancy when administered to a pregnant female. Advise males with female partners of reproductive potential to use effective contraception during treatment with XTANDI and for 3 months after the last dose of XTANDI.

Adverse Reactions (ARs)

In the data from the four randomized placebo-controlled trials, the most common ARs ( 10%) that occurred more frequently ( 2% over placebo) in XTANDI-treated patients were asthenia/fatigue, back pain, hot flush, constipation, arthralgia, decreased appetite, diarrhea, and hypertension. In the bicalutamide-controlled study, the most common ARs ( 10%) reported in XTANDI-treated patients were asthenia/fatigue, back pain, musculoskeletal pain, hot flush, hypertension, nausea, constipation, diarrhea, upper respiratory tract infection, and weight loss.

In AFFIRM, the placebo-controlled study of metastatic CRPC (mCRPC) patients who previously received docetaxel, Grade 3 and higher ARs were reported among 47% of XTANDI-treated patients. Discontinuations due to adverse events (AEs) were reported for 16% of XTANDI-treated patients. In PREVAIL, the placebo-controlled study of chemotherapy-naive mCRPC patients, Grade 3-4 ARs were reported in 44% of XTANDI patients and 37% of placebo patients. Discontinuations due to AEs were reported for 6% of XTANDI-treated patients. In TERRAIN, the bicalutamide-controlled study of chemotherapy-naive mCRPC patients, Grade 3-4 ARs were reported in 39% of XTANDI patients and 38% of bicalutamide patients. Discontinuations with an AE as the primary reason were reported for 8% of XTANDI patients and 6% of bicalutamide patients.

In PROSPER, the placebo-controlled study of non-metastatic CRPC (nmCRPC) patients, Grade 3 or higher ARs were reported in 31% of XTANDI patients and 23% of placebo patients. Discontinuations with an AE as the primary reason were reported for 9% of XTANDI patients and 6% of placebo patients.

In ARCHES, the placebo-controlled study of metastatic CSPC (mCSPC) patients, Grade 3 or higher AEs were reported in 24% of XTANDI-treated patients. Permanent discontinuation due to AEs as the primary reason was reported in 5% of XTANDI patients and 4% of placebo patients.

Lab Abnormalities: Lab abnormalities that occurred in 5% of patients, and more frequently (> 2%) in the XTANDI arm compared to placebo in the pooled, randomized, placebo-controlled studies are neutrophil count decreased, white blood cell decreased, hyperglycemia, hypermagnesemia, hyponatremia, and hypercalcemia.

Hypertension: In the combined data from four randomized placebo-controlled clinical trials, hypertension was reported in 12% of XTANDI patients and 5% of placebo patients. Hypertension led to study discontinuation in < 1% of patients in each arm.

Drug Interactions

Effect of Other Drugs on XTANDI Avoid coadministration with strong CYP2C8 inhibitors. If coadministration cannot be avoided, reduce the dosage of XTANDI.

Avoid coadministration with strong CYP3A4 inducers. If coadministration cannot be avoided, increase the dosage of XTANDI.

Effect of XTANDI on Other Drugs Avoid coadministration with certain CYP3A4, CYP2C9, and CYP2C19 substrates for which minimal decrease in concentration may lead to therapeutic failure of the substrate. If coadministration cannot be avoided, increase the dosage of these substrates in accordance with their Prescribing Information. In cases where active metabolites are formed, there may be increased exposure to the active metabolites.

Indications

XTANDI (enzalutamide) is indicated for the treatment of patients with:

  • castration-resistant prostate cancer (CRPC)
  • metastatic castration-sensitive prostate cancer (mCSPC)

Please see Full Prescribing Information.