Warning: Cytokine release syndrome and neurologic toxicity including immune effector cell-associated neurotoxicity syndrome.

• Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TECVAYLI.
• Initiate treatment with TECVAYLI step-up dosing schedule to reduce risk of CRS.
• Withhold TECVAYLI until CRS resolves or permanently discontinue based on severity. 
• Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and serious and life-threatening reactions, can occur in patients receiving TECVAYLI.
• TECVAYLI is available only through a restricted program called the TECVAYLI Risk Evaluation and Mitigation Strategy (REMS).