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  • FDA Date: 10/18/2017

    Yescarta (axicabtagene ciloleucel) REMS

    Goals of the Yescarta (axicabtagene ciloleucel)REMS Program

    The goals of the YESCARTA REMS are to mitigate the risks of cytokine release syndrome (CRS) and neurological toxicities by:

    • Ensuring that hospitals and their associated clinics that dispense YESCARTA are specially certified and have on-site, immediate access to tocilizumab.

    • Ensuring those who prescribe, dispense, or administer YESCARTA are aware of how to manage the risks of CRS and neurological toxicities.

    REMS Elements

    • Elements to Assure Safe Use

    • Implementation System