XTANDI® (enzalutamide) capsules Privacy Statement
Astellas Pharma US, Inc. (Astellas) and Medivation, Inc. respect the privacy of visitors to our online sites. Astellas and Medivation, 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 Medivation, 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 Medivation, 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 Medivation, 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.
- Cookies also allow Astellas and Medivation, Inc. to determine whether you came to this site from another Astellas and Medivation, Inc. site or from an advertising banner or link on a non-Astellas or Medivation, 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 Medivation, 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.
In addition to cookies, Astellas or Medivation, 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 Medivation, Inc. web sites use a third party advertising service to display advertising on other, non-Astellas or Medivation, Inc. web sites. In addition to placing advertisements on certain non-Astellas and Medivation, Inc. web pages, these services and/or Astellas and Medivation, Inc. may also place a segment of code called a clear pixel tag, also known as a "gif", on certain Astellas and Medivation, 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 Medivation, 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 Medivation, Inc. web server logs collect statistical data that is generated by your computer when it visits a Astellas and Medivation, 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 Medivation, 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 Medivation, 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 Medivation, 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.
You may stop receiving future communications from this web site, or any further Astellas or Medivation, Inc. communications, at any time. To cancel further communications, please complete the following to unsubscribe.
From time to time, Astellas and Medivation, Inc. may decide to modify its practices and policies, and we reserve the right to revise this Astellas and Medivation, Inc. internet privacy statement as necessary to disclose such changes in our practices and policies. Any such changes to this Astellas and Medivation, 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 Medivation, Inc. and/or the companies we hire in a manner that is consistent with the Astellas and Medivation, 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 Medivation, Inc. internet privacy statement.
Questions about Astellas' Internet Privacy Statement, including categories of data collection, may be directed to firstname.lastname@example.org.
©2016-2017 Astellas Pharma US, Inc. All rights reserved.
XTANDI (enzalutamide) capsules is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC).
Important Safety Information
XTANDI is not indicated for women. XTANDI can cause fetal harm and potential loss of pregnancy.
Warnings and Precautions
Seizure occurred in 0.5% of patients receiving XTANDI in clinical studies. In placebo-controlled studies, 8 of 1671 (0.5%) patients treated with XTANDI and 1 of 1243 (0.1%) patients treated with placebo experienced a seizure. In patients who previously received docetaxel, 7 of 800 (0.9%) patients treated with XTANDI experienced a seizure and no patients treated with placebo experienced a seizure. In a placebo-controlled study in chemotherapy-naïve patients, 1 of 871 (0.1%) patients treated with XTANDI and 1 of 844 (0.1%) patients treated with placebo experienced a seizure. In bicalutamide-controlled studies conducted in chemotherapy-naïve patients, 3 of 380 (0.8%) patients treated with XTANDI and 1 of 387 (0.3%) patients treated with bicalutamide experienced a seizure. Permanently discontinue XTANDI in patients who develop a seizure during treatment.
Posterior Reversible Encephalopathy Syndrome (PRES) In post approval use, there have been reports of PRES in patients receiving XTANDI. PRES is a neurological disorder which 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.
The most common adverse reactions (≥ 10%) that occurred more commonly (≥ 2% over placebo) in the XTANDI patients from the two placebo-controlled clinical trials were asthenia/fatigue, back pain, decreased appetite, constipation, arthralgia, diarrhea, hot flush, upper respiratory tract infection, peripheral edema, dyspnea, musculoskeletal pain, weight decreased, headache, hypertension, and dizziness/vertigo. In the bicalutamide-controlled study of chemotherapy-naïve patients, the most common adverse reactions (≥ 10%) reported in XTANDI patients were asthenia/fatigue, back pain, musculoskeletal pain, hot flush, hypertension, nausea, constipation, upper respiratory tract infection, diarrhea, and weight loss.
In the study of patients taking XTANDI who previously received docetaxel, Grade 3 and higher adverse reactions were reported among 47% of XTANDI patients and 53% of placebo patients. Discontinuations due to adverse events were reported for 16% of XTANDI patients and 18% of placebo patients. In the placebo-controlled study of chemotherapy-naïve patients, Grade 3-4 adverse reactions were reported in 44% of XTANDI patients and 37% of placebo patients. Discontinuations due to adverse events were reported for 6% of both study groups. In the bicalutamide-controlled study of chemotherapy-naïve patients, Grade 3-4 adverse reactions were reported in 38.8% of XTANDI patients and 37.6% of bicalutamide patients. Discontinuations due to adverse events were reported for 7.6% of XTANDI patients and 6.3% of bicalutamide patients.
Lab Abnormalities: In the two placebo-controlled trials, Grade 1-4 neutropenia occurred in 15% of XTANDI patients (1% Grade 3-4) and 6% of placebo patients (0.5% Grade 3-4). Grade 1-4 thrombocytopenia occurred in 6% of XTANDI patients (0.3% Grade 3-4) and 5% of placebo patients (0.5% Grade 3-4). Grade 1-4 elevations in ALT occurred in 10% of XTANDI patients (0.2% Grade 3-4) and 16% of placebo patients (0.2% Grade 3-4). Grade 1-4 elevations in bilirubin occurred in 3% of XTANDI patients (0.1% Grade 3-4) and 2% of placebo patients (no Grade 3-4).
Infections: In a study of patients taking XTANDI who previously received docetaxel, 1% of XTANDI patients compared to 0.3% of placebo patients died from infections or sepsis. In the placebo-controlled study of chemotherapy-naïve patients, 1 patient in each treatment group (0.1%) had an infection resulting in death.
Falls (including fall-related injuries) occurred in 9% of XTANDI patients and 4% of placebo patients in the two placebo-controlled trials. Falls were not associated with loss of consciousness or seizure. Fall-related injuries were more severe in XTANDI patients, and included non-pathologic fractures, joint injuries, and hematomas.
Hypertension occurred in 11% of XTANDI patients and 4% of placebo patients in the two placebo-controlled trials. No patients experienced hypertensive crisis. Medical history of hypertension was balanced between arms. Hypertension led to study discontinuation in < 1% of patients in each arm.
Effect of Other Drugs on XTANDI Avoid strong CYP2C8 inhibitors, as they can increase the plasma exposure to XTANDI. If co-administration is necessary, reduce the dose of XTANDI.
Avoid strong CYP3A4 inducers as they can decrease the plasma exposure to XTANDI. If co-administration is necessary, increase the dose of XTANDI.
Effect of XTANDI on Other Drugs Avoid CYP3A4, CYP2C9, and CYP2C19 substrates with a narrow therapeutic index, as XTANDI may decrease the plasma exposures of these drugs. If XTANDI is co-administered with warfarin (CYP2C9 substrate), conduct additional INR monitoring.
Please see Full Prescribing Information for additional safety information.