Risk Evaluation and Mitigation Strategies (REMS) Summary

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FDA Date: 9/19/17

Suboxone/Subutex REMS

Goals of the Suboxone/Subutex REMS Program

The goals of the REMS for SUBOXONE sublingual film, SUBOXONE sublingual tablets and SUBUTEX sublingual tablets are to:

• Mitigate the risks of accidental overdose, misuse and abuse
• Inform prescribers, pharmacists, and patients of the serious risks associated with SUBOXONE sublingual film, SUBOXONE sublingual tablets and SUBUTEX sublingual tablets

REMS Elements

• Medication Guide

• Elements to Assure Safe Use

• Implementation System

Open the Full REMS Notification

REMS Summary of Terms