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

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

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

Adolor is pleased to provide you with information about 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 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 12-month study in patients treated with opioids for chronic pain, there was a numeric imbalance in myocardial infarctions in patients treated with alvimopan 0.5 mg twice daily compared with placebo-treated patients. This imbalance has not been observed in other studies of alvimopan, including studies in patients undergoing bowel resection who received alvimopan 12 mg twice daily for up to 7 days. A causal relationship with alvimopan has not been established.1,2 As a result, the E.A.S.E. Program was developed to help ensure that ENTEREG is administered only short term in inpatient hospital settings and for no more than 15 doses.

This program requires:

  1. The E.A.S.E. Program educational materials have been provided to healthcare practitioners who are responsible for the prescribing, 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 patient, 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. Registered hospitals may Log in to Search for Other Registered Hospitals prior to completing any transfer of ENTEREG.

The E.A.S.E. Program Enrollment Form and Registration 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 Form and Registration Kit.

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).