VIVITROL® (naltrexone for extended-release injectable suspension)
INFORMATION FOR 
HEALTHCARE PROFESSIONALS 

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