Because of the risk of liver toxicity, JUXTAPID is available only through a restricted program called the JUXTAPID Risk Evaluation and Mitigation Strategy (REMS) Program. Aegerion will certify all health care providers who prescribe JUXTAPID and the pharmacies that will dispense the medicine. The goals of the REMS are:
- To educate prescribers about:
- the risk of hepatotoxicity associated with the use of JUXTAPID; and
- the need to monitor patients during treatment with JUXTAPID as per product labeling.
- To restrict access to therapy with JUXTAPID to patients with a clinical or laboratory diagnosis consistent with HoFH.