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  • FDA Date: 10/23/2017

    Soliris (eculizumab) Injection REMS

    Goals of the Soliris (eculizumab) Injection REMS Program

    The goals of the REMS are:

    • To mitigate the occurrence and morbidity associated with meningococcal infections

    • To educate Healthcare Professionals (HCPs) and Patients regarding:

          - the increased risk of meningococcal infections with Soliris

          - the early signs of invasive meningococcal infections, and

          - the need for immediate medical evaluation of signs and symptoms consistent with possible meningococcal infections

    REMS Elements

    • Medication Guide

    • Elements to Assure Safe Use