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.
The safety and effectiveness of JUXTAPID have not been established in patients with hypercholesterolemia who do not have HoFH. The effect of JUXTAPID on cardiovascular morbidity and mortality has not been determined. The safety and effectiveness of JUXTAPID have not been established in pediatric patients.
To further understand JUXTAPID's long-term safety and effectiveness, Aegerion has made a commitment to the FDA to conduct a post-approval, observational cohort study.
As part of the planned launch of JUXTAPID, the company has developed a comprehensive support services program for patients and their healthcare providers. For more information, call this toll-free number, 1-85JUXTAPID (1-855-898-2743).
Important Safety Information, including BOXED WARNING which states:
WARNING: RISK OF HEPATOTOXICITY
JUXTAPID can cause elevations in transaminases. In the JUXTAPID clinical trial, 10 (34%) of the 29 patients treated with JUXTAPID had at least one elevation in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3x upper limit of normal (ULN). There were no concomitant clinically meaningful elevations of total bilirubin, international normalized ratio (INR), or alkaline phosphatase.
JUXTAPID also increases hepatic fat, with or without concomitant increases in transaminases. The median absolute increase in hepatic fat was 6% after both 26 and 78 weeks of treatment, from 1% at baseline, measured by magnetic resonance spectroscopy. Hepatic steatosis associated with JUXTAPID treatment may be a risk factor for progressive liver disease, including steatohepatitis and cirrhosis.