Learn about and Enroll in
the E.A.S.E.™ Program

Adolor and GlaxoSmithKline (GSK) are pleased to introduce you to ENTEREG and the E.A.S.E. (Entereg Access Support and Education) Program. One-time enrollment in the E.A.S.E. program permits hospitals performing bowel resection surgeries to receive ENTEREG. It is important that you understand this program in order to help your pharmacy order, stock and dispense ENTEREG.

ENTEREG, a peripherally acting μ-opioid receptor antagonist, is indicated to accelerate the time to upper and lower gastrointestinal (GI) recovery following partial large or small bowel resection with primary anastomosis. ENTEREG is approved for short-term use in the hospital setting. ENTEREG is available only to hospitals that perform bowel resections and are enrolled in the E.A.S.E. Program.

In one long-term (12-month) clinical study of alvimopan in patients treated with opioids for chronic pain, a numeric imbalance was seen in the incidence of ischemic cardiovascular events. As a result, the E.A.S.E. program was developed to ensure that ENTEREG is administered only short-term in inpatient, hospital settings, and for no more than 15 doses. See Important Safety Information.

This program requires:

1. The E.A.S.E. Program Enrollment kit has been received by the hospital and provided to the healthcare practitioners who are responsible for the ordering, dispensing, and administering of ENTEREG.
2. The hospital has systems, order sets, protocols, or other measures in place to limit the use of ENTEREG to no more than 15 doses per patients for administration in the hospital only.
3. The hospital will not dispense ENTEREG for outpatient use and will not transfer ENTEREG to any hospital not registered with the E.A.S.E. program. Approved hospitals may login to search for other approved hospitals prior to completing any transfer of ENTEREG.

The E.A.S.E. Program Enrollment Kit contains all materials necessary to register your inpatient hospital pharmacy

• Registration form
• Ordering information
• Hospital Brochure
• Complete Prescribing Information for ENTEREG

Click here to download the E.A.S.E. Enrollment Kit.

Watch the Educational
Video for the E.A.S.E.
Program

Prescribing Information including Boxed Warning

Important Safety Information

• 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).