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Adempas (riociguat) Tablets REMS
Goals of the Adempas (riociguat) Tablets REMS Program
The goals of the Adempas REMS are:
1. To inform prescribers, patients, and pharmacists about the serious risk of teratogenicity and safe-use conditions for Adempas
2. To minimize the risk of fetal exposure and adverse fetal outcomes in Females of Reproductive Potential (FRP) prescribed Adempas:
a. Females who are pregnant must not be prescribed Adempas
b. Females taking Adempas must not become pregnant
• Medication Guide
• Elements to Assure Safe Use
• Implementation System