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.

See additional Important Safety Information below

ENTEREG is the first and only FDA-approved agent indicated to accelerate the time to upper and lower
GI recovery following partial large or small bowel resection surgery with primary anastomosis

Privacy Statement

Adolor respects the privacy of visitors to our online sites. Adolor 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. Adolor 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 Adolor 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 Adolor or by a third party. Cookies may be used for a variety of purposes on this Web site:

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This is not an exhaustive list of all uses of cookies on Adolor Web sites. In all cases in which cookies are used, however, neither Adolor, 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.

Some Adolor Web sites may use a third-party advertising service to display advertising on other, non-Adolor Web sites. In addition to placing advertisements on certain non-Adolor Web pages, these services and/or Adolor may also place a segment of code called a clear pixel tag, also known as a "GIF", on certain Adolor 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, Adolor 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. Adolor Web server logs collect statistical data that is generated by your computer when it visits an Adolor 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. Adolor 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.

Adolor uses technical and organizational security precautions, in order to protect your data from coincidental or deliberate manipulation, loss, destruction, or access by unauthorized persons. Our security procedures are continuously revised based on new technological developments.

This Adolor 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, Adolor's Web sites may 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, Adolor may decide to modify its practices and policies, and we reserve the right to revise this Adolor Internet Privacy Statement as necessary to disclose such changes in our practices and policies. Any such changes to this Adolor Internet Privacy Statement will be promptly communicated on this page. Any information that you submit before the change in policy will be used by Adolor and/or the companies we hire in a manner that is consistent with the Adolor 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 Adolor Internet Privacy Statement.

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 Capsules are 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

  • Overall, the incidence of adverse reactions in short-term surgical clinical trials was similar between patients receiving either ENTEREG or placebo. Most common adverse reactions in patients treated with ENTEREG (incidence ≥3% with ENTEREG and at least 1% greater than placebo) undergoing bowel resection were anemia, dyspepsia, hypokalemia, back pain, and urinary retention

  • 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 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).