Risk Evaluation and Mitigation Strategies (REMS) Summary

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FDA Date: 6/27/17

Thalomid (thalidomide) Capsules REMS

Goals of the Thalomid (thalidomide) Capsules REMS Program

The goals of the THALOMID risk evaluation and mitigation strategy are as follows:

• To prevent the risk of embryo-fetal exposure to THALOMID.

• To inform prescribers, patients, and pharmacists on the serious risks and safe-use conditions for THALOMID.

REMS Elements

• Elements to Assure Safe Use

• Implementation System

REMS Summary of Terms