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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.
• Elements to Assure Safe Use• Implementation System