Risk Evaluation and Mitigation Strategies (REMS) Summary

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FDA Date: 6/1/16

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

Open the Full REMS Notification

REMS Summary of Terms