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:
- 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.
- JUXTAPID is dispensed only to patients with a clinical or laboratory diagnosis consistent with homozygous familial hypercholesterolemia (HoFH).
- 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.
What assessment is available to the REMS?
Assessment Plan |
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REMS assessment plan unavailable for posting at this time. |
What updates have been made to the REMS?
Date | Summary of change |
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01/25/2024 | Revised to reflect change in application ownership. |
06/16/2022 | Modified to reflect:
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02/01/2022 | Modified to:
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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:
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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.