Risk Evaluation and Mitigation Strategies (REMS) Summary

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FDA Date: 6/27/17

Revlimid (lenalidomide) REMS

Goals of the Revlimid (lenalidomide) REMS Program

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

1. To prevent the risk of embryo-fetal exposure to REVLIMID.

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

REMS Elements

• Elements to Assure Safe Use

• Implementation System

REMS Summary of Terms