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

Dosing and Administration

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

Make ENTEREG Part of Your Preoperative and Postoperative Routine1

Proactive dosing prior to surgery1

  • ENTEREG is for hospital use only
  • Patients should not receive more than 15 total doses of ENTEREG
  • ENTEREG is available only to hospitals that enroll in the E.A.S.E. Program

Special populations

Geriatric Use: No dosage adjustment based on increased age.

Hepatic Impairment: No dosage adjustment is necessary in patients with mild-to-moderate hepatic impairment (Child-Pugh Class A and B), but they should be monitored for adverse effects. ENTEREG is not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C).

Renal Impairment: No dosage adjustment is necessary in patients with mild-to-severe renal impairment, but they should be monitored for adverse effects. ENTEREG is not recommended for use in patients with end-stage renal disease.

Race: No dosage adjustment is necessary in Black, Hispanic, and Japanese patients; however, Japanese patients should be monitored for possible adverse effects.

Pediatric Use: Safety and efficacy have not been established.
« Efficacy Adverse Reactions »
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).


Reference: 1. ENTEREG [package insert]. Exton, PA: Adolor Corporation; 2009.