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Approved Risk Evaluation and Mitigation Strategies (REMS)

Juxtapid (lomitapide)
NDA #203858
REMS last update: 01/25/2024



What is the purpose of the REMS?

The goal 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; and the need to monitor patients during treatment with JUXTAPID as per product labeling.
  2. JUXTAPID is dispensed only to patients with a clinical or laboratory diagnosis consistent with homozygous familial hypercholesterolemia (HoFH).
  3. Patients are informed about the risk of hepatotoxicity associated with the use of JUXTAPID and the need for baseline and periodic monitoring.

What do participants need to know?

Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

What assessment is available to the REMS?

Assessment Plan
REMS assessment plan unavailable for posting at this time.

What updates have been made to the REMS?

Date Summary of change
01/25/2024 Revised to reflect change in application ownership.
06/16/2022 Modified to reflect:
  • A revised Prescription Authorization Form (PAF) consolidated to one page instead of 2 pages, so that the prescriber signature and the drug order are not separated by a page break
  • Addition of state-specific pharmacy practice language to increase pharmacy usability and reduce necessity of pharmacy intervention on incoming prescriptions in the PAF as follows:
    • “The prescriber shall comply with his/her state-specific prescription requirements such as e-prescribing, state-specific prescription form, fax language, etc., as required. Noncompliance with state-specific requirements could result in pharmacy outreach to the prescriber.”
  • Removal of the “scan and email” option from the PAF.
  • Updated the Juxtapid (lomitapide) REMS website screenshots to align with changes to the PAF
02/01/2022 Modified to:
  1. Update the format of the REMS document in line with the recommendations in the Format and Content of a REMS Document- Guidance for Industry.
  2. Change program materials secondary to findings of the completed Qualitative Research (QR) around the deficit of prescriber knowledge on program requirements around liver monitoring as demonstrated in recent poor KAB survey scores.
  3. Omit obsolete materials (2017 Stakeholder letters).
  4. Make editorial changes such as added demographic fields to Patient Guide, Patient Prescriber Acknowledgement Form (PPAF) and Prescription Authorization Form (PAF) and other editorial revisions related to punctuation, grammar, spelling, defining acronyms, flow, font, simplification, and consistency to REMS appended materials.
05/27/2021 Modified to add online fillable fields in REMS forms and modified the design and formatting of the REMS materials.
10/21/2020 Revised to make editorial changes.
05/18/2020 Revised to reflect change in ownership.
03/13/2020 Revised to make editorial changes.
06/13/2019 Revised to update the corporate address.
06/18/2018 Revised to make an editorial change.
06/04/2018 Modified to:

  1. remove the option of emailing completed Patient-Prescriber Authorization Forms (PPAFs) for protection of patient information
  2. require patients reaching age 18 to sign a PPAF (previously signed by a parent)
  3. add language on the website to clarify the order of actions for prescriber participation in the REMS
  4. establish an all-electronic process for submission of the certificate of completion of training and knowledge assessment
  5. streamline the process for completion of the prescriber enrollment form (use of auto-completion of the form using prescriber information already submitted)
  6. add text to the REMS website requesting pharmacies to contact Aegerion before attempting to certify
  7. update font colors on REMS forms to enhance readability
  8. add clarifying language on the Prescription Authorization Form (PAF) regarding how to submit a prescription
03/02/2017 Revised to make an editorial change.
01/03/2017 Modified to conform to the Safety Labeling Change Notification/REMS Modification Notification letter issued on March 11, 2016 in the REMS document, the existing REMS materials, and the following new REMS materials: Patient Guide and Patient-Prescriber Acknowledgement Form.
08/13/2013 Modified to allow prescribers to complete the REMS-required training and enrollment online.
12/21/2012 Approval of the REMS.

Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.

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