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Axicabtagene Ciloleucel

Cytokine Release Syndrome and Neurologic Toxicities

  • Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving YESCARTA. Do not administer YESCARTA to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids. 
  • Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving YESCARTA, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with YESCARTA. Provide supportive care and/or corticosteroids, as needed.
  • YESCARTA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the YESCARTA REMS.

Approved Risk Evaluation and Mitigation Strategies (REMS)

YESCARTA (Axicabtagene Ciloleucel) Suspension for Intravenous Infusion

Patient Counseling Information

Package Inserts

Axicabtagene Ciloleucel

Updated November 2017