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  • FDA Date: 08/25/2017

    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

    REMS Elements

    • Medication Guide

    • Elements to Assure Safe Use

    • Implementation System