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  • FDA Date: 01/17/2017

    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

    REMS Elements

    • Medication Guide

    • Elements to Assure Safe Use

    • Implementation System