Legal Notices

Adolor Corporation (Adolor) and GlaxoSmithKline (GSK) offer products and services to diagnose, prevent 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.) or the Committee on Safety of Medicine in the United Kingdom. These regulations often restrict the prescribing information that can be disclosed to the public so that you need to consult with your health care 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 Adolor and GSK. Like any other service, in spite of our best efforts the information in this Web Site may become out of date over time.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 health care professional to advise you on your specific situation. Adolor and GSK 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.

Copyright and Intellectual Property

Adolor and GSK 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 Adolor and GSK or any third party. Except as expressly provided above, nothing contained herein shall be construed as conferring any license or right under any Adolor copyright or GSK copyright.

Trademarks and service marks owned by or licensed to Adolor or GSK are presented as italicized typefaces, such as Seretide or Tums. British and American spellings are used, depending on the author or source of the information. Adolor and GSK claim no ownership in, nor any affiliation with, any third-party trademarks appearing in this Web Site. Such third-party trademarks are used only to identify the products and services of their respective owners, and no sponsorship or endorsement on the part of Adolor or GSK should be inferred from the use of these marks.

Should any viewer of an Adolor or a GSK published document respond with information including feedback data such as questions, comments, suggestions, or the like regarding the content of any such Adolor or GSK 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.

Prescribing Information including Boxed Warning

Important Safety Information

WARNING: FOR SHORT-TERM HOSPITAL USE ONLY
ENTEREG is available only for short-term (15 doses) use in hospitalized patients.
Only hospitals that have registered in and met all of the requirements for the
ENTEREG Access Support & Education (E.A.S.E.™) Program may use ENTEREG.
  • ENTEREG is contraindicated in patients who have taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking ENTEREG
  • There were more reports of myocardial infarctions in patients treated with alvimopan 0.5 mg twice daily compared with placebo-treated patients in a 12-month study of patients treated with opioids for chronic pain. In this study, the majority of myocardial infarctions occurred between 1 and 4 months after initiation of treatment. This imbalance has not been observed in other studies of alvimopan, including studies of patients undergoing bowel resection surgery who received alvimopan 12 mg twice daily for up to 7 days. A causal relationship with alvimopan has not been established
  • ENTEREG should be administered with caution to patients receiving more than 3 doses of an opioid within the week prior to surgery. These patients may be more sensitive to ENTEREG and may experience GI side effects (eg, abdominal pain, nausea and vomiting, diarrhea)
  • ENTEREG is not recommended for use in patients with severe hepatic impairment, end-stage renal disease, or in patients undergoing surgery for correction of complete bowel obstruction
  • ENTEREG is available only to hospitals that enroll in the E.A.S.E. Program. To enroll in the E.A.S.E. Program, the hospital must acknowledge that:
    • Hospital staff who prescribe, dispense, or administer ENTEREG have been provided the educational materials on the need to limit use of ENTEREG to short-term, inpatient use
    • Patients will not receive more than 15 doses of ENTEREG
    • ENTEREG will not be dispensed to patients after they have been discharged from the hospital

Adverse event reporting

Healthcare professionals should report all suspected adverse events associated with the use of ENTEREG. Please contact Adolor Corporation at 700 Pennsylvania Drive, Exton, PA 19341 or
1-866-4ADOLOR (1-866-423-6567).

Alternatively, this information may be reported to the FDA MedWatch Reporting System by phone at 1-800-FDA-1088 (1-800-332-1088) or by mail using Form 3500 at www.fda.gov/medwatch.

If you have any questions, please contact Adolor Corporation at 1-866-4ADOLOR (1-866-423-6567).