The JUXTAPID® Risk Evaluation and Mitigation Strategy (REMS) Program
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.
Aegerion Pharmaceuticals, Inc. (Aegerion) has worked with the FDA to develop the JUXTAPID REMS Program.
The purpose of the JUXTAPID REMS Program 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
- The need to monitor patients during treatment with JUXTAPID, as per the product labeling
- JUXTAPID is dispensed only to patients with a clinical or laboratory diagnosis consistent with homozygous familial hypercholesterolemia
- Patients are informed about the risk of hepatotoxicity associated with the use of JUXTAPID and the need for baseline and periodic monitoring
All prescribers of JUXTAPID must become certified in the JUXTAPID REMS Program.
The 3-step process for Prescriber Certification is outlined below:
- Review the JUXTAPID Prescribing Information and the JUXTAPID REMS Program Fact Sheet
- Complete the online Prescriber Training Module and Prescriber Enrollment Form
- Agree to counsel each patient using the Patient Guide, and to complete a 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 other lipid-lowering treatments, including LDL apheresis where available, to reduce low-density lipoprotein cholesterol (LDLC), total cholesterol (TC), apolipoprotein B (apo B), and non-high-density lipoprotein cholesterol (non-HDL-C) in patients with homozygous familial hypercholesterolemia (HoFH).
Limitations of Use
- The safety and effectiveness of JUXTAPID have not been established in patients with hypercholesterolemia who do not have HoFH, including those with heterozygous familial hypercholesterolemia (HeFH).
- The effect of JUXTAPID on cardiovascular morbidity and mortality has not been determined.