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

• YESCARTA

Package Inserts

Axicabtagene Ciloleucel