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.
• Elements to Assure Safe Use
• Implementation System