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Myalept - Chiesi Farmaceutici, S.p.A.

Manufacturer
Chiesi Farmaceutici, S.p.A.
Effective date
2025-09-17
Label type
Risk Evaluation & Mitigation Strategies
Version
9
Source
full-release
Hydrated at
2026-06-04 22:50:42

Label at a glance#

ProductMyalept
Label structure6 sections

Label contents#

Full prescribing information#

I. Administrative Information

REMS ADMINISTRATIVE INFORMATION

Risk: Anti-metreleptin antibodies with neutralizing activity Lymphoma
Application Number: BLA 125390
Application Holder: Chiesi Farmaceutici, S.p.A
Initial REMS Approval: 02/2014
Most Recent REMS Update: 09/2025

II. REMS Goal

REMS GOALS

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

III. REMS Requirements

REMS REQUIREMENTS

Chiesi Farmaceutici, S.p.A must ensure that healthcare providers, patients, outpatient pharmacies, and wholesalers-distributors comply with the following requirements:

1. Healthcare Providers who prescribe Myalept must:

REMS PARTICIPANT REQUIREMENTS

To become certified to prescribe1. Review the drug's Prescribing Information.
2. Review the following: Prescriber Training Module.
3. Enroll in the REMS by completing the Prescriber Enrollment Form and submitting it to the REMS program.
Before treatment initiation (first dose)4. Assess the patient to confirm the clinical diagnosis is consistent with the approved indication.
5. Counsel the patient on the risks of Myalept.
6. Order the prescription using the Prescription Authorization Form.
During treatment; before each prescription7. Order the prescription using the Prescription Authorization Form.
During treatment8. Assess the patient's condition for the 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).

2. Patients who are prescribed Myalept:

REMS PARTICIPANT REQUIREMENTS

Before treatment initiation1. Receive counseling from the prescriber on the risks of Myalept.
During treatment2. Be monitored for neutralizing antibodies.

3. Outpatient Pharmacies that dispense Myalept must:

REMS PARTICIPANT REQUIREMENTS

To become certified to dispense1. Designate an authorized representative to carry out the certification process and oversee implementation and compliance with the REMS on behalf of the pharmacy.
2. Train all relevant staff involved in dispensing of Myalept on the REMS requirements.
3. Establish processes and procedures to verify that the prescriber is certified and a completed Prescription Authorization Form is received for each new prescription.
Before dispensing4. 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.
At all times5. Not distribute, transfer, loan, or sell Myalept.
6. Maintain and submit records of prescription data to the REMS program.
7. Maintain records that all REMS processes and procedures are in place and are being followed.
8. 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.

4. Wholesalers-distributors that distribute Myalept must:

REMS PARTICIPANT REQUIREMENTS

To be able to distribute1. 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.
2. Train all relevant staff involved in distributing on the program requirements.
At all times3. Distribute only to outpatient certified pharmacies, or to inpatient pharmacies authorized by the REMS call center.
4. Maintain records of drug distribution.
5. 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.

REMS APPLICANT REQUIREMENTS

Chiesi Farmaceutici, S.p.A. must provide training to healthcare providers who prescribe Myalept.

The training includes the following educational material: Prescriber Training Module. The training must be available online or by contacting the REMS call center.

To support REMS operations, Chiesi Farmaceutici, S.p.A. must:

1. Establish and maintain a REMS website, www.MYALEPTREMS.com. The REMS website must include the option to print the Prescribing Information, Medication Guide, and REMS materials. All product websites for consumers and health care providers must include prominent REMS-specific links to the REMS website. The REMS website must not link back to the promotional product website(s).
2. Make the REMS website fully operational and all REMS materials available through the REMS website or call center.
3. Establish and maintain a REMS call center for REMS participants at 1-855-6MYALEPT (1-855-669-2537).
4. Establish and maintain a validated, secure database of all REMS participants who are enrolled and/or certified in the Myalept REMS.
5. Ensure prescribers are able to enroll in the REMS by fax.
6. Ensure outpatient pharmacies are able to certify with the manufacturer and agreeing to comply with the requirements of the REMS.
7. Ensure inpatient pharmacies are able to contact the REMS call center for assistance in obtaining Myalept for a specific inpatient who has a certified prescriber and a Prescription Authorization Form on file with a certified pharmacy.
8. Provide the Prescriber Training Module, Prescriber Enrollment Form, Myalept REMS: An Introduction, and the Prescribing Information to REMS participants who (1) attempt to prescribe Myalept and are not yet certified or (2) inquire about how to become certified.
9. Notify prescribers and pharmacies within 48 hours after they become certified in the REMS.
10. Provide certified pharmacies access to the database of certified prescribers.

To ensure REMS participants' compliance with the REMS, Chiesi Farmaceutici, S.p.A. must:

11. Maintain adequate records to demonstrate that REMS requirements have been met, including, but not limited to records of: Myalept distribution and dispensing; certification of prescribers and pharmacies; and audits of REMS participants. These records must be readily available for FDA inspections.
12. Establish a plan for addressing noncompliance with REMS requirements.
13. Monitor certified prescribers and pharmacies on an ongoing basis to ensure the requirements of the REMS are being met. Take corrective action if non-compliance is identified, including de-certification.
14. Audit all certified pharmacies no later than 180 days after they become certified, and annually thereafter to ensure that all REMS processes and procedures are in place, functioning, and support the REMS requirements.
15. Audit all wholesalers-distributors no later than 180 days after they become authorized, and annually thereafter to ensure that all REMS processes and procedures are in place, functioning, and support the REMS requirements.
16. Take reasonable steps to improve implementation of and compliance with the requirements in the Myalept REMS based on monitoring and evaluation of the Myalept REMS.

IV. REMS Assessment Timetable

REMS TIMETABLE FOR SUBMISSION ASSESSMENTS

Chiesi Farmaceutici, S.p.A. must submit a REMS Assessment on February 24, 2026, and every 2 years thereafter. To facilitate inclusion of as much information as possible while allowing reasonable time to prepare the submission, the reporting interval covered by each assessment should conclude no earlier than 60 calendar days before the submission date for that assessment. Chiesi Farmaceutici, S.p.A. must submit each assessment so that it will be received by the FDA on or before the due date.

V. REMS Materials

REMS MATERIAL

The following materials are part of the Myalept REMS:

Enrollment Forms

Prescriber:

1. Prescriber Enrollment Form

Training and Educational Materials

Prescriber:

2. Prescriber Training Module

3. Myalept REMS: An Introduction

Patient Care Forms

4. Prescription Authorization Form

Other Materials

5. REMS Website (www.MYALEPTREMS.com)

VI. Statutory Elements

REMS ELEMENTS

This REMS is required under section 505-1 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355-1) and consists of the following elements:

  1. Elements to Assure Safe Use:
    • Health care providers who prescribe Myalept are specially certified under 505-1(f)(3)(A)
    • Pharmacies and health care settings that dispense Myalept are specially certified under 505-1(f)(3)(B)
    • Myalept is dispensed to patients with evidence or other documentation of safe-use conditions under 505-1(f)(3)(D)
  2. Implementation System
  3. Timetable for Submission of Assessments

DailyMed Product Concepts#

Product concept, Relation, Version table
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454a5988-c452-4c4d-90ee-89badfa9b5dfProduct name120150616

DailyMed REMS / Drug Safety Documents#

Labels related to this REMS document

DailyMed label, Relation, Version table
DailyMed labelRelationVersionEffectiveManufacturerSource
These highlights do not include all the information needed to use MYALEPT safely and effectively. See full prescribing information for MYALEPT. MYALEPT ® (metreleptin) for injection, for subcutaneous use Initial U.S. Approval: 2014SPL related document2024-03-25Chiesi USA, Inc.20251003_67d2cb97-aadd-42b3-a1a7-e4236e5638fe.zip!4ff7fd2f-0ef4-4673-a3e8-ed4181acfe45.xml

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MyaleptMETRELEPTINChiesi USA, Inc.d3b50bbd-140b-425c-b5ec-d4682aad62bc2024-03-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Myalept

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