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


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.

Contraindications

  • ENTEREG Capsules are contraindicated in patients who have taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking ENTEREG

Warnings and Precautions

  • 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

Adverse Reactions

  • 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

Distribution Program for ENTEREG

  • 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).