For U.S. Audience Only.
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A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration (FDA) to ensure that the benefits of the drug outweigh its risks.
VIVITROL, when used as part of a comprehensive management program, is indicated for the following:
Providers and patients should be aware of the following risks of VIVITROL: