XTANDI® (enzalutamide) capsules Legal Notice
Astellas Pharma US, Inc. (Astellas) and Pfizer Inc. offer a product and select services to diagnose and treat disease. Their prescription medicines for use by healthcare professionals are regulated by government agencies in each of the countries in which they do business, such as the Food and Drug Administration in the United States (U.S.). These regulations often restrict the prescribing information that can be disclosed to the public so that you need to consult with your healthcare professional. You may also need to visit other healthcare web sites to find out more about prescription products.
This web site has been developed as a service of Astellas and Pfizer Inc. Like any other service, in spite of our best efforts the information in this web site may become out of date over time. Nothing on this web site should be construed as the giving of advice or the making of a recommendation and it should not be relied on as the basis for any decision or action. It is important that you rely only on the advice of a healthcare professional to advise you on your specific situation. YOU SHOULD NEVER DISREGARD OR DELAY SEEKING MEDICAL ADVICE BECAUSE OF SOMETHING THAT YOU HAVE SEEN ON THIS SITE. PLEASE CONSULT WITH YOUR DOCTOR, OR OTHER QUALIFIED HEALTH CARE PROFESSIONAL, BEFORE USING ANY OBLIGATIONS DISCUSSED ON THIS SITE. Astellas and Pfizer Inc. accept no liability for the accuracy or completeness or use of, nor any liability to update, the information contained on this web site. These materials are provided "as is" without warranty of any kind, either expressed or implied, including, but not limited to, the implied warranties of merchantability, fitness for a particular purpose, or non-infringement. Some jurisdictions do not allow the exclusion of implied warranties, so the above exclusion may not apply to you.
This U.S.-based web site may link you to other web sites on the internet, including the web sites for Astellas and Pfizer Inc. affiliates in other countries. Neither Astellas nor Pfizer Inc. take responsibility for information found on third-party web sites outside its control. While Astellas and Pfizer Inc. attempt to provide links only to third-party web sites that comply with all applicable laws and regulations and Astellas or Pfizer Inc. standards, please understand that the content on these third-party web sites is subject to change without notice to Astellas or Pfizer Inc. Neither Astellas nor Pfizer Inc. therefore can be responsible for, and accept no liability for, any information or opinion contained in any third-party web site.
Nothing on this web site constitutes an invitation or offer to invest or deal in the securities or ADRs of Astellas or Pfizer Inc. In particular, actual results and developments may be materially different from any forecast, opinion or expectation expressed on this web site and the past performance of the price of securities must not be relied on as a guide to their future performance.
COPYRIGHT AND INTELLECTUAL PROPERTY
Please feel free to browse this web site. Your access and use of the information herein are subject to the following terms and conditions, and all applicable laws. By accessing and browsing this web site, you accept, without limitation or qualification, these terms and conditions and acknowledge that they supersede any other agreement between you and Astellas.
Astellas and Pfizer Inc. hereby authorize you to copy materials published on this web site for non-commercial use only, provided any copy of these materials which you make shall retain all copyright and other proprietary notices and any disclaimer contained thereon and on this web site.
Nothing contained herein shall be construed as conferring by implication, estoppel or otherwise any license or right under any patent or trademark of Astellas Pharma US, Inc. or Pfizer Inc. or any third party. Except as expressly provided above, nothing contained herein shall be construed as conferring any license or right under any Astellas copyright or Pfizer Inc. copyright.
Names, trademarks, service marks, trade names, trade dress, logos and product of Astellas appearing on this site are protected in the United States and internationally and may not be used for advertising or publicity purposes, or to indicate any affiliation with or endorsement by Astellas or Pfizer Inc., except with the express written permission of Astellas or Pfizer Inc. Nothing contained herein shall be construed as conferring any license or right under any Astellas or Pfizer Inc. copyright. Other product, service and company names mentioned on the Site are for identification purposes only and may be trademarks of their respective owners.
Should any viewer of a Astellas or a Pfizer Inc. published document respond with information including feedback data such as questions, comments, suggestions, or the like regarding the content of any such Astellas or Pfizer Inc. material, such information shall be deemed to be non-confidential and we shall have no obligation of any kind with respect to such information and shall be free to reproduce, use, disclose, and distribute the information to others without limitation. We shall be free to use any ideas, concepts, know-how or techniques contained in such information for any purpose whatsoever including but not limited to developing, manufacturing and marketing products incorporating such information.
OBLIGATIONS OF SITE VISITORS OR USERS. You agree not to do any of the following while visiting or using the Site or any Services provided by or through this Site:
Impersonate or misrepresent your affiliation with any person or entity; except as expressly permitted by the rules of this Site, post or transmit any unsolicited advertising, promotional materials, (junk mail), (spam), (chain letters), or any other form of solicitation on the Site or through the Services; post or transmit any information or material that is defamatory, offensive, indecent, obscene, or unlawful; post or transmit any information or software which contains a virus, trojan horse, worm or other harmful components; violate any applicable law or regulation, including without limitation any local, state, provincial, national or international law, any export control laws, or any regulations promulgated by any state or federal authority; access or use password protected, secure or non-public areas of the Site without authorization; or frame, repackage, or otherwise re-distribute any portion of the Site.
LIMITATION OF LIABILITY. In no event will Astellas and Pfizer Inc. be liable for any damages whatsoever, including but not limited to direct, indirect, incidental, punitive, and consequential damages (including without limitation those resulting from lost profits, lost data or business interruption) arising out of the use, inability to use, or the result of use of this site, any web sites linked to this site, the materials or information contained at any or all such sites, or the materials, products or services offered on this site or sites linked to this site, whether based on warranty, contact, tort or any other legal theory and whether or not advised on the possibility of such damages. In no event will Astellas or Pfizer Inc., their suppliers, or any other party involved in creating, producing, or delivering this site be liable to you in any manner whatsoever for any design made or action or non-action taken by you in reliance upon information provided through this site. Applicable law may not allow the exclusion or limitation of incidental or consequential damages so the above limitation or exclusion may not apply to you.
©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 a study of patients with predisposing factors, seizures were reported in 2.2% of patients. See section 5.1 of the Prescribing Information for the list of predisposing factors. It is unknown whether anti-epileptic medications will prevent seizures with XTANDI. 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 placebo-controlled 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 the 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 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.
FORMULARY STATUS DOES NOT IMPLY SAFETY OR EFFICACY.
A product’s placement on a plan formulary involves a variety of factors known only to the applicable plan and is subject to eligibility. Provider communication only—not approved for prescription drug plan member distribution. Formulary status is not a guarantee. Please verify copay, coinsurance, coverage, and updated information with the plan sponsors. Information subject to change without notice. Astellas does not endorse any individual plans.