Approved Risk Evaluation and Mitigation Strategies (REMS)

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Myalept (metreleptin)
BLA #125390
REMS last update: 12/21/2018



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

Healthcare Providers who prescribe Myalept must

To become certified to prescribe
  • Review the drug's Prescribing Information.
  • Review the following: Prescriber Training Module.
  • Enroll in the REMS by completing the Prescriber Enrollment Form and submitting it to the REMS Program.
Before treatment initiation (first dose)
  • Assess the patient to confirm the clinical diagnosis is consistent with the approved indication.
  • Counsel the patient on the risks of Myalept.
  • Order the prescription using the Prescription Authorization Form.
During treatment; before each prescription
  • Order the prescription using the Prescription Authorization Form.
During treatment
  • Assess the patient's condition for presence of neutralizing antibodies if a patient experiences severe infections or if you suspect Myalept treatment is no longer working (e.g., loss of glycemic control, increased triglycerides).

Patients who are prescribed Myalept

Before treatment initiation
  • Receive counseling from the prescriber on the risks of Myalept.
During treatment
  • Be monitored for neutralizing antibodies.

Outpatient Pharmacies that dispense Myalept must

To become certified to dispense
  • Designate an authorized representative to carry out the certification process and oversee implementation and compliance with the REMS Program on behalf of the pharmacy.
  • Train all relevant staff involved in dispensing of Myalept on the REMS Program requirements.
  • Establish processes and procedures to verify that the prescriber is certified and a completed Prescription Authorization Form is received for each new prescription.
Before dispensing
  • Verify that the prescriber is certified and a completed Prescription Authorization Form is received for each new prescription through the processes and procedures established as a requirement of the REMS Program.
At all times
  • Not distribute, transfer, loan, or sell Myalept.
  • Maintain and submit records of prescription data to the REMS Program.
  • Maintain records that all REMS processes and procedures are in place and are being followed.
  • Comply with audits carried out by Aegerion or a third party acting on behalf of Aegerion, to ensure that all processes and procedures are in place and are being followed.

Wholesalers-distributors that distribute Myalept must

To be able to distribute
  • Establish processes and procedures to ensure the drug is distributed only to certified outpatient pharmacies, or to inpatient pharmacies authorized by the REMS Program call center.
  • Train all relevant staff involved in distributing on the program requirements.
At all times
  • Distribute only to outpatient certified pharmacies, or to inpatient pharmacies authorized by the REMS Program call center.
  • Maintain records of drug distribution.
  • Comply with audits carried out by Aegerion Pharmaceuticals, Inc. or a third party acting on behalf of Aegerion Pharmaceuticals, Inc., to ensure that all processes and procedures are in place and are being followed.

What materials are included in the REMS?

The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers. For a specific Medication Guide of a product in the Myalept REMS, see the DailyMed link(s).
Material Name Material Name Link
Letter for Healthcare Providers (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2018_12_21_Letter_for_Healthcare_Providers.pdf
Myalept REMS Program: An Introduction (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2018_12_21_Myalept_REMS_Program_An_Introduction.pdf
Prescriber Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2018_12_21_Prescriber_Enrollment_Form.pdf
Prescriber Training Module (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2018_12_21_Prescriber_Training_Module.pdf
Prescription Authorization Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2018_12_21_Prescription_Authorization_Form.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2018_12_21_REMS_Document.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2018_12_21_REMS_Full.pdf
REMS Program Website Screenshots (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Myalept_2018_12_21_REMS_Program_Website_Screenshots.pdf

What updates have been made to the REMS?

Date Summary of change
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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