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:
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:
Physicians must attest to the patient having a diagnosis consistent with Generalized Lipodystrophy.
Healthcare providers who prescribe MYALEPT must review the prescriber training materials to enroll in the MYALEPT REMS.
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.
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.com.