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:

Providers and patients should be aware of the following risks of VIVITROL:

Materials for Healthcare Providers

Dear Healthcare Provider Letter Patient Counseling Tool
for Providers
Important Injection Safety
Information Poster

To order any of the healthcare
provider materials, call:

1-800-848-4876

and press 1.

  • Dear Healthcare Provider Letter
  • Patient Counseling Tool for Providers
  • Important Injection Safety
    Information Poster
  • Patient Wallet Card
  • Patient Safety Bracelet

As of December 8, 2015, VIVITROL® (naltrexone for extended-release injectable suspension) has new Prescribing Information (12/2015). The Dosage and Administration, Section 2.4 Directions for Use has been updated. When administering VIVITROL, please refer to Section 2.4 Directions for Use in the VIVITROL Prescribing Information that is provided in the carton you are administering.