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FDA Date: 08/30/2017
Kymriah (tisagenlecleucel) Injection REMS
Goals of the Kymriah (tisagenlecleucel) REMS Program
The goals of the Kymriah REMS Program are to mitigate the risks of cytokine release syndrome (CRS) and neurological toxicities by:• Ensuring that hospitals and their associated clinics that dispense Kymriah are specially certified and have on-site, immediate access to tocilizumab.• Ensuring those who prescribe, dispense, or administer Kymriah are aware of how to manage the risks of cytokine release syndrome and neurological toxicities.
• Elements to Assure Safe Use
• Implementation System