The JUXTAPID® Risk Evaluation and Mitigation Strategy (REMS)
A REMS is a strategy to manage known or potential serious risks associated with a drug and is required by the US Food and Drug Administration (FDA) to ensure that the benefits of the drug outweigh its risks.
The purpose of the JUXTAPID REMS is to mitigate the risk of hepatotoxicity associated with the use of JUXTAPID by ensuring that:
1. Prescribers are educated about:
- The approved indication for JUXTAPID
- The risk of hepatotoxicity associated with the use of JUXTAPID
- The need to monitor patients during treatment with JUXTAPID, as per the product labeling
2. JUXTAPID is dispensed only to patients with a clinical or laboratory diagnosis consistent with homozygous familial hypercholesterolemia
3. Patients are informed about the risk of hepatotoxicity associated with the use of JUXTAPID and the need for baseline and periodic liver monitoring
Prescriber
All prescribers of JUXTAPID must become certified in the JUXTAPID REMS.
The 3-step process for Prescriber Certification is outlined below:
1. Review the JUXTAPID Prescribing Information and the Fact Sheet
2. Complete the online Prescriber Training Module and Prescriber Enrollment Form
3.
Agree to counsel each patient using either the Pediatric Patient Guide or the Adult Patient Guide, and to complete an appropriate Patient-Prescriber Acknowledgement Form with each patient
INDICATIONS AND USAGE
Homozygous Familial Hypercholesterolemia
JUXTAPID is indicated as an adjunct to a low-fat diet and exercise and other low-density lipoprotein cholesterol (LDL-C) therapies, to reduce LDL-C in adult and pediatric patients aged 2 years and older with HoFH.