RISK EVALUATION AND MITIGATION STRATEGY (REMS)
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:
- Treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL
- Prevention of relapse to opioid dependence, following opioid detoxification
Providers and patients should be aware of the following risks of VIVITROL:
- Risk of opioid overdose
- Severe injection site reactions
- Precipitation of opioid withdrawal during initiation and re-initiation of VIVITROL
- Hepatotoxicity
- Patients may not feel the therapeutic effects of opioid-containing medicines for pain, cough or cold, or diarrhea while taking VIVITROL