Risk Evaluation and Mitigation Strategies (REMS) Summary

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FDA Date: 1/23/17

Buprenorphine-Containing Transmucosal Products for Opioid Dependence (BTOD) REMS

Goals of the Buprenorphine-Containing Transmucosal Products for Opioid Dependence (BTOD) REMS Program

The goals of the Buprenorphine-containing Transmucosal products for Opioid Dependence (BTOD) REMS are to:

• Mitigate the risks of accidental overdose, misuse, and abuse

• Inform prescribers, pharmacists, and patients of the serious risks associated with buprenorphine-containing products

REMS Elements

• Medication Guide

• Elements to Assure Safe Use

• Implementation System

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REMS Summary of Terms