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 and Education (E.A.S.E.™) Program may use ENTEREG.

ENTEREG Capsules are contraindicated in patients who have taken therapeutic doses of opioids for greater 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 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.

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 (incidence ≥3% and ≥1% placebo) in patients undergoing bowel resection were anemia, dyspepsia, hypokalemia, back pain, and urinary retention.

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.

Please see complete Prescribing Information, including Boxed Warning.

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