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ENTEREG is indicated to accelerate the time to upper and lower gastrointestinal recovery following surgeries that include partial bowel resection with primary anastomosis.
Important Safety Information for ENTEREG
WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION WITH LONG-TERM USE: FOR SHORT-TERM HOSPITAL USE ONLY
- Increased incidence of myocardial infarction was seen in a clinical trial of patients taking alvimopan for long-term use. No increased risk was observed in short-term trials.
- Because of the potential risk of Myocardial Infarction, ENTEREG is available only through a restricted program for short-term use (15 doses) called the ENTEREG Access Support and Education (E.A.S.E.®) ENTEREG REMS Program.
- 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, complete gastrointestinal obstruction, or pancreatic or gastric anastomosis, or in patients who have had surgery for correction of complete bowel obstruction.
- The most common adverse reaction (incidence ≥1.5%) occurring with a higher frequency than placebo among ENTEREG-treated patients undergoing surgeries that included a bowel resection was dyspepsia (ENTEREG, 1.5%; placebo, 0.8%).
E.A.S.E. Program for ENTEREG
ENTEREG is available only to hospitals that enroll in the E.A.S.E. ENTEREG REMS 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 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).
©2014 Cubist Pharmaceuticals, Inc., Lexington, MA, USA.
All rights reserved. ENTEREG and E.A.S.E. are registered trademarks of Adolor Corporation, a wholly owned subsidiary of Cubist Pharmaceuticals, Inc. All other trademarks or registered trademarks are the property of their respective owners. 5673010814