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.
• Elements to Assure Safe Use
• Implementation System