Approved Risk Evaluation and Mitigation Strategies (REMS)

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Myalept (metreleptin)
BLA #125390
REMS last update: 11/28/2016

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:
  1. 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
  2. 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

To be able to prescribe Myalept
  • Review the prescribing information for Myalept.
  • Review the educational materials for prescribers, including the Prescriber Training Module.
    | Prescriber Training Module |
  • Enroll in the REMS by completing and submitting the Prescriber Enrollment Form.
    | Prescriber Enrollment Form |
Before writing the first prescription for a patient
  • Assess the patient’s medical history to confirm the clinical diagnosis is consistent with the approved indication.
  • Counsel the patient on the benefits and risks of Myalept.
  • Complete and submit the Prescription Authorization Form.
    | Prescription Authorization Form |
Before writing each prescription after the first prescription
  • Assess patient’s condition for the presence of neutralizing antibodies if a patient experiences severe infections, or if they suspect Myalept treatment is no longer working (e.g., loss of glycemic control, increased triglycerides).
  • Complete and submit the Prescription Authorization Form.
    | Prescription Authorization Form |

Patients who receive Myalept

Before receiving the initial Myalept prescription
  • Receive counseling from the prescriber on the risks and benefits.

Pharmacies that dispense Myalept

To be able to dispense Myalept
  • Designate an authorized representative to carry out the certification process on behalf of the pharmacy.
  • Train all relevant staff involved in the dispensing of Myalept on the program requirements.
  • Establish processes and procedures to verify that the prescriber is certified and the Prescription Authorization Form is received for each new prescription.
    | Prescription Authorization Form |
Before dispensing Myalept
  • Do not distribute, transfer, loan, or sell product.
  • Provide sponsor with records of prescription data.
  • Cooperate with audits carried out by the sponsor 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
MYALEPT REMS Program: An Introduction (PDF)
Prescriber Enrollment Form (PDF)
Prescriber Training Module (PDF)
Prescription Authorization Form (PDF)
REMS document (PDF)
REMS full (PDF)
REMS website screenshot (PDF)

What updates have been made to the REMS?

Date Summary of change
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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