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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
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.
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
on behalf of the pharmacy.
Train all relevant staff involved in dispensing of Myalept on the REMS
requirements.
Establish processes and procedures to verify that the prescriber is
certified and a completed Prescription Authorization Form is received
for each new prescription.
| Prescription Authorization Form |
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.
| Prescription Authorization Form |
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 Chiesi or a third party acting on
behalf of Chiesi, 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 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 call center.
Maintain records of drug distribution.
Comply with audits carried out by Chiesi Farmaceutici, S.p.A. or a
third party acting on behalf of Chiesi Farmaceutici, S.p.A. 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).
This webpage provides REMS assessment plan measures, metrics, and indicators for drug and biological products with a REMS. The REMS assessment plan measures, metrics, and indicators are part of the overall REMS assessment plan used by FDA to evaluate the performance of a REMS and are included in FDA approval letters. The current REMS assessment plan measures, metrics, and indicators are extracted from regulatory letters that contain REMS information, including FDA approval letters, and posted here as they become available.
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.
