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  • FDA Date: 05/17/2016

    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