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.
• Elements to Assure Safe Use
• Implementation System