Risk Evaluation and Mitigation Strategies (REMS) Summary

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FDA Date: 6/17/17

Isotretinoin REMS

Goals of the Isotretinoin REMS Program

The goals of the isotretinoin risk evaluation and mitigation strategy are:

1. To prevent fetal exposure to isotretinoin

2. To inform prescribers, pharmacists, and patients about isotretinoin's serious risks and safe-use conditions

REMS Elements

• Medication Guide

• Elements to Assure Safe Use

• Implementation System

REMS Summary of Terms