Risk Evaluation and Mitigation Strategies (REMS) Summary

Goal of the Probuphine (buprenorphine hydrochloride) Implant REMS Program

The goal of the Probuphine REMS is to mitigate the risk of complications of migration, protrusion, expulsion and nerve damage associated with the insertion and removal of Probuphine and the risks of accidental overdose, misuse and abuse by:

a) Ensuring that healthcare providers are educated on the following:

• proper insertion and removal of Probuphine

• risk of complications of migration, protrusion, expulsion and nerve damage associated with the insertion and removal of Probuphine

• risks of accidental overdose, misuse and abuse if an implant comes out or protrudes from the skin

b) Informing patients about the risks of complications of migration, protrusion, expulsion and nerve damage associated with insertion and removal, as well as the risks of accidental overdose, misuse and abuse if an implant comes out or protrudes from the skin.

REMS Elements

• Medication Guide

• Elements to Assure Safe Use

• Implementation System

Open the Full REMS Notification

REMS Summary of Terms