FDA Date: 6/27/17
Pomalyst (pomalidomide) Capsules REMS
Goals of the Pomalyst (pomalidomide) Capsules REMS Program
The goals of the POMALYST risk evaluation and mitigation strategy are as follows:
1. To prevent the risk of embryo-fetal exposure to POMALYST.
2. To inform prescribers, patients, and pharmacists on the serious risks and safe-use conditions for POMALYST.
• Elements to Assure Safe Use
• Implementation System