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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 Opsumit2. 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