JUXTAPID REMS Program
A Risk Evaluation and Mitigation Strategy (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
- • 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 homozygous familial hypercholesterolemia (HoFH).
JUXTAPID is only available through the JUXTAPID REMS Program. The JUXTAPID REMS Program requirements include:
- • For Prescribers
- - Training on the risk of hepatotoxicity associated with the use of JUXTAPID; appropriate patient selection and monitoring; and the REMS requirements
- - Certification by completion of training, and enrollment in the JUXTAPID REMS Program
- - Attestation of patient safe use for each new prescription by completing a Prescription Authorization Form
Find out more about Training and Enrollment
- • For Pharmacies
- - Certification and enrollment in the REMS Program in order to dispense JUXTAPID
- - Restricted distribution of JUXTAPID to patients with prescriptions from prescribers who are enrolled in the JUXTAPID REMS Program
- - Prescriber documentation of safe use conditions with Presciption Authorization Form
Training & Enrollment
Healthcare professionals who prescribe JUXTAPID must review the prescriber training materials to enroll in the JUXTAPID REMS Program.
Review the Prescriber Education Materials
Complete and Submit the JUXTAPID REMS Program Prescriber Enrollment Form
You can do this in two ways:
- Online or
- Download the JUXTAPID REMS Program Prescriber Enrollment Form or request a copy by calling
- • Complete the Enrollment Form and return via fax or email:
By completing the Prescriber Enrollment Form, the prescriber agrees to comply with the JUXTAPID REMS Program requirements. A confirmation of your certification in the JUXTAPID REMS Program will be sent to you so you can begin to prescribe JUXTAPID.
Before starting a patient on JUXTAPID, enrolled prescribers must:
- • Affirm that the patient has a clinical or laboratory diagnosis consistent with HoFH.
- • Obtain liver-related laboratory tests as directed in the JUXTAPID prescribing information.
- • Confirm the absence of pregnancy and counsel the patient about the potential for fetal harm, if the patient is a woman of reproductive potential. Instruct her to use reliable methods of contraception and confirm use. Instruct patients to contact their prescriber immediately and stop taking JUXTAPID if pregnancy should occur.
- • Complete and submit the prescription using the JUXTAPID REMS Prescription Authorization Form documenting safe use conditions. A Prescription Authorization Form is required to be submitted for each new prescription.
Phone: 1-85-JUXTAPID (1-855-898-2743)
Hours of Operation: Monday-Friday: 8 AM-7 PM ET
To learn more about the risk of hepatotoxicity associated with the use of JUXTAPID, please refer to the Prescribing Information. Before initiating treatment with JUXTAPID, prescribers must discuss the risks of JUXTAPID with their patients.
Reporting of Adverse Reactions
All healthcare professionals should report all suspected adverse reactions. Please contact Aegerion Pharmaceuticals, Inc. at 1-855-303-2347 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.