Risk Evaluation and Mitigation Strategies (REMS) Summary

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FDA Date: 5/17/16

Vivitrol (naltrexone) Extended-Release Injectable Suspension REMS

Goals of the Vivitrol (naltrexone) Extended-Release Injectable Suspension REMS Program

The goals of this REMS are:
• To inform patients and healthcare providers about severe injection site reactions associated with the use of VIVITROL.
• To inform healthcare providers about the importance of counseling their patients about severe injection site reactions associated with the use of VIVITROL.

REMS Elements

• Medication Guide
• Communication Plan

Open the Full REMS Notification

REMS Summary of Terms