Appropriate Patient Selection
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 is specifically intended to limit the population exposed to MYALEPT to mitigate 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. Because of these risks, appropriate patient selection consistent with the approved indication of congenital or acquired generalized lipodystrophy for MYALEPT is required.
The MYALEPT REMS 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 Can Only Be Prescribed in Accordance with the FDA-Approved Indication:
MYALEPT is indicated as an adjunct to diet as replacement therapy to treat the complications of leptin-deficiency in patients with congenital or acquired generalized lipodystrophy.
Do Not Prescribe MYALEPT for Any Other Indications Including:
- Treatment of complications associated with partial lipodystrophy
- Treatment of liver disease, including nonalcoholic steatohepatitis (NASH)
- HIV-related lipodystrophy
- Metabolic disease, including diabetes mellitus and hypertriglyceridemia, without concurrent evidence of generalized lipodystrophy
- General obesity not associated with congenital leptin deficiency
Physicians must attest to the patient having a diagnosis consistent with Generalized Lipodystrophy.
Program Requirements
For Prescribers:
- Certify in the MYALEPT REMS to prescribe MYALEPT
- Attest patients have a diagnosis consistent with congenital or acquired generalized lipodystrophy
- Complete the Prescription Authorization Form for each new prescription
For Outpatient Pharmacies:
- Certify in the MYALEPT REMS to dispense MYALEPT
- Verify prescriber is certified and a completed Prescription Authorization Form is received
Training & Enrollment
Healthcare providers who prescribe MYALEPT must review the prescriber training materials to enroll in the MYALEPT REMS.
Steps to Prescriber Certification
1. Review the Prescriber Education Materials
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 requirements. A confirmation of your certification in the MYALEPT REMS will be sent to you so you can begin to prescribe MYALEPT.
Reporting Adverse Reactions
Healthcare providers should report all suspected adverse events.
Please contact the company at 1-855-669-2537 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Please contact the company at 1-855-669-2537 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
