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
ENTEREG achieves selective GI opioid antagonism without reversing the central analgesic effects of μ-opioid agonists.1 ENTEREG blocks the peripheral effects of opioids on GI motility and secretion by competitively binding to GI tract μ-opioid receptors.1 This antagonism was evident in guinea pig ileum.1
ENTEREG did not reverse opioid analgesia in clinical trials, as measured by visual analog scale (VAS) pain intensity scores and/or amount of postop opioids administered.1
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).
References: 1. ENTEREG [package insert]. Exton, PA: Adolor Corporation; 2009. 2. Data on file. Adolor Corporation. 3. Delaney CP, Weese JL, Hyman NH, et al; for the Alvimopan Postoperative Ileus Study Group. Phase III trial of alvimopan, a novel, peripherally acting, mu opioid antagonist, for postoperative ileus after major abdominal surgery. Dis Colon Rectum. 2005;48:1114-1129. 4. Viscusi ER, Goldstein S, Witkowski T, et al. Alvimopan, a peripherally acting mu-opioid receptor antagonist, compared with placebo in postoperative ileus after major abdominal surgery: results of a randomized, double-blind, controlled study. Surg Endosc. 2006;20:64-70. 5. Wolff BG, Michelassi F, Gerkin TM, et al. Alvimopan, a novel, peripherally acting µ opioid antagonist: results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial of major abdominal surgery and postoperative ileus. Ann Surg. 2004;240(4):728-735. 6. Ludwig K, Enker WE, Delaney CP, et al. Gastrointestinal tract recovery in patients undergoing bowel resection: results of a randomized trial of alvimopan and placebo with a standardized accelerated postoperative care pathway. Arch Surg. 2008;143(11):1098-1105.
