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  • FDA Date: 12/11/2017

    Myalept (metreleptin) for Injection REMS

    Goal of the Myalept (metreleptin) for Injection REMS Program

    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:

    • 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

    REMS Elements

    • Communication Plan

    • Elements to Assure Safe Use

    • Implementation System