Risk Evaluation and Mitigation Strategies (REMS) Summary

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FDA Date: 6/1/16 12:00 AM EDT

Entereg (alvimopan) Capsules REMS

Goal of the Entereg (alvimopan) Capsules REMS Program

The goal of the E.A.S.E. ENTEREG REMS Program is to mitigate the potential risk of myocardial infarction by:

• Ensuring that ENTEREG (alvimopan) is used only for short-term use (no more than 15 doses) in a hospital inpatient setting

• Informing healthcare providers about the potential risk of myocardial infarction observed with long-term use of ENTEREG.

REMS Elements

• Elements to Assure Safe Use

• Implementation System

REMS Summary of Terms