Potential Risk of Myocardial Infarction with Long-Term Use; For Short-Term Hospital Use Only

• There was a greater incidence of myocardial infarction in alvimopan-treated patients compared to placebo-treated patients in a 12-month clinical trial, although a causal relationship has not been established. In short-term trials with ENTEREG®, no increased risk of myocardial infarction was observed [see Warnings and Precautions (5.1)].

• Because of the potential risk of myocardial infarction with long-term use, ENTEREG is available only through a restricted program for short-term use (15 doses) under a Risk Evaluation and Mitigation Strategy (REMS) called the ENTEREG Access Support and Education (E.A.S.E.®) Program [see Warnings and Precautions (5.1) and (5.2)].