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Approved Risk Evaluation and Mitigation Strategies (REMS)

Myalept (metreleptin)
BLA #125390
REMS last update: 03/06/2024



What is the purpose of the REMS?

The goal of the MYALEPT REMS is to mitigate

  1. the risks of serious adverse sequelae (such as severe infections, excessive weight gain, glucose intolerance, diabetes mellitus) due to the development of anti-metreleptin antibodies that neutralize endogenous leptin and/or MYALEPT, and

  2. the risk of lymphoma by:
  • Educating prescribers about the development of neutralizing anti-metreleptin antibodies,the serious adverse sequelae that may result from these antibodies, and the risk for lymphoma associated with MYALEPT
  • Limiting the population exposed to MYALEPT by requiring prescriber certification, pharmacy certification, and prescriber attestation that each patient has a diagnosis consistent with the approved indication

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
03/06/2024 Revised to reflect change in application ownership
03/31/2023 Modified to revise REMS materials to include reformatting and content streamlining to align with the REMS goal and Prescribing Information and to increase the prominence of messaging around appropriate patient selection and reinforcement of adherence to REMS requirements for prescribers. Remove the communication plan as an element of the REMS.
06/09/2021 Modified to revise minor formatting changes and update forms with "fillable fields" for use on the Myalept program website.
10/15/2020 Revised to make editorial changes.
07/13/2020 Modified to revise the “For Administration” section in the Prescription Authorization Form.
03/13/2020 Revised to make editorial changes.
12/21/2018 Modified to:
  • Clarify the process for supplying Myalept for hospitalized patients
  • Update the REMS Introduction Sheet to make the format consistent with the rest of the REMS materials
  • Update the Prescriber Training module by removing the requirement to send a copy of the completed consent for NAb testing to Aegerion
  • Update the REMS document to the current formal which includes describing the wholesalers and distributors requirements
12/11/2017 Modified to revise prescriber training materials to highlight the risk of developing severe infections and the availability of testing for anti-metreleptin neutralizing antibodies if severe infections occur, and and the addition of a new communication plan which includes a new REMS letter to currently certified prescribers to inform them of the availability of updated training materials.
11/28/2016 Revised to correct a typographical error(s)
11/07/2016 Revised to correct a typographical error(s).
08/27/2015 Modified to reflect the transfer of ownership from Amylin Pharmaceuticals to Aegerion Pharmaceuticals, Inc in the REMS document and REMS materials.
06/30/2014 Modified to revise the prescription authorization form (PAF) and changes to reflect new ownership in the appended REMS materials.
02/24/2014 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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