A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration (FDA) to ensure that the benefits of a drug outweigh its risks.
The MYALEPT REMS Program was developed with the FDA:
To educate prescribers about
- the development of anti-metreleptin antibodies that neutralize endogenous leptin and/or MYALEPT and the serious adverse events that may result from these antibodies,
- the risk of lymphoma, and
- appropriate patient selection
MYALEPT is available only through the MYALEPT REMS Program. The MYALEPT REMS Program requirements include:
- Certification of prescribers of MYALEPT
- Certification consists of completion of training, and enrollment in the MYALEPT REMS Program
- Completion of a Prescription Authorization form for each new prescription
Find out more about Training & Enrollment.
- Restricted distribution of MYALEPT to patients with completed Prescription Authorization Forms from prescribers who are certified in the MYALEPT REMS Program
Training & Enrollment
Healthcare providers who prescribe MYALEPT must review the prescriber training materials to enroll in the MYALEPT REMS Program.
Steps to Prescriber Certification
1.Review the Prescriber Education Materials
- MYALEPT Prescribing Information
- Prescriber Training Module
2.Complete and submit the MYALEPT REMS Program Prescriber Enrollment Form
- Print and sign the Prescriber Enrollment Form or request a copy by calling 1-855-669-2537
- Submit the form via Fax to 1-877-328-9682
By completing the Prescriber Enrollment Form, the prescriber agrees to comply with the MYALEPT REMS Program requirements. A confirmation of your certification in the MYALEPT REMS program will be sent to you so you can begin to prescribe MYALEPT.
Reporting Adverse Reactions