Alvimopan - BlackBoxRX.com

Alvimopan

Warning: For Short-Term Hospital Use Only

Alvimopan is available only for short term (15 doses) use in hospitalized patients.
Only hospitals that have registered in and met all of the requirements for the Entereg (alvimopan) Access Support and Education (E.A.S.E) program may use this drug. (see Warnings and Precautions)

Black box on New Drug Approval: May 2008

Approved Risk Evaluation and Mitigation Strategies (REMS)

Entereg (alvimopan) Capsules (PDF - 2120KB)

Updated May 2010

Disclaimer: This information presents a SUMMARY of Black Box data from product information labeling and does not address additional warnings, precautions, or other important safety data in the product insert. Patient care decisions SHOULD NOT be made without reviewing the most recent product information insert, which may be obtained from the manufacturer. This table may not be complete as it was prepared using product information from package inserts. It is periodically updated with supplemental information from FDA safety alerts, the FDA labeling announcements, and new drug approvals.

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