Entereg is the first and only FDA-approved agent indicated to accelerate the time to upper and lower gastrointestinal (GI) recovery following partial large or small bowel resection surgery with primary anastomosis.

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.

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About Entereg

In clinical trials,a Entereg

All phase 3 clinical study arms were managed with a standard, accelerated postoperative care pathway.

  • aData are from multicenter, randomized, double-blind, placebo-controlled studies in patients undergoing bowel resection with primary anastomosis. Patients who received more than 3 doses of an opioid (regardless of route) during the 7 days prior to surgery and patients with complete bowel obstruction or who were scheduled for a total colectomy, colostomy, or ileostomy were excluded.
  • bGI recovery = toleration of solid food and first bowel movement

 

Important Safety Information for 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

  • 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

E.A.S.E. 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

Please see full Prescribing Information, including Boxed Warning.

Adverse Event Reporting

Healthcare professionals should report all suspected adverse events associated with the use of Entereg. Please contact Cubist Pharmaceuticals at 1-877-CUBIST-6 (1-877-282-4786).

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 Cubist Pharmaceuticals at 1-877-CUBIST-6 (1-877-282-4786).

Health Economics of Entereg

This information is intended only for members of formulary committees, those persons who influence formulary committee decisions, and any one evaluation formulary product decisions on behalf of an organization, pursuant to Section 114 of the FDA Modernization Act of 1997.