Important Safety
Information & Dosing

Adverse reactions observed in clinical studies1

Treatment-emergent adverse reactions

*Treatment-emergent adverse reactions that were reported in ≥3% of either bowel resection patients treated with ENTEREG or all surgical patients treated with ENTEREG and for which the rate for ENTEREG was ≥1% than placebo.

Drug interactions1

  • Low probability of drug interactions of ENTEREG when coadministered with CYP 450 and P-glycoprotein substrates, inducers, or inhibitors
  • Treatment effect consistent regardless of use of acid blockers or antibiotics

Proactive Dosing prior to surgery1

Usual Dosage in Adults

ENTEREG is for hospital use only. The recommended adult dosage of ENTEREG is 12 mg administered 30 minutes to 5 hours prior to surgery followed by 12 mg twice daily beginning the day after surgery for a maximum of 7 days or until discharge. Patients should not receive more than 15 doses of ENTEREG.

Dosing

Special Populations

To learn more about dosing ENTEREG with special populations, see complete Prescribing Information.

NEXT: The E.A.S.E. Program

Prescribing Information including Boxed Warning

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 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).