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  • FDA Date: 03/02/2017

    Juxtapid (lomitapide) Capsules REMS

    Goal of the Juxtapid (lomitapide) Capsules REMS Program

    The goal of the JUXTAPID REMS is to mitigate the risk of hepatotoxicity associated with the use of JUXTAPID by ensuring that:

    • Prescribers are educated about the approved indication for JUXTAPID, the risk of hepatotoxicity associated with the use of JUXTAPID; and the need to monitor patients during treatment with JUXTAPID as per product labeling.

    • JUXTAPID is dispensed only to patients with a clinical or laboratory diagnosis consistent with homozygous familial hypercholesterolemia (HoFH).

    • Patients are informed about the risk of hepatotoxicity associated with the use of JUXTAPID and the need for baseline and periodic monitoring.

    REMS Elements

    • Elements to Assure Safe Use

    • Implementation System