FDA Date: 8/25/17
Opsumit (macitentan) Tablets REMS
Goals of the Opsumit (macitentan) Tablets REMS Program
The goals of the REMS are:
1. To inform prescribers, patients, and pharmacists about the serious risk of teratogenicity and safe-use conditions for Opsumit
2. To minimize the risk of fetal exposure and adverse fetal outcomes in females of reproductive potential (FRP) prescribed Opsumit:
a) Females who are pregnant must not be prescribed Opsumit
b) Females taking Opsumit must not become pregnant
• Medication Guide
• Elements to Assure Safe Use
• Implementation System