Cytokine Release Syndrome and Neurologic Toxicities

• Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving BREYANZI. Do not administer BREYANZI to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab with or without corticosteroids [see DOSAGE AND ADMINISTRATION (2.2, 2.3) and WARNINGS AND PRECAUTIONS (5.1)].
• Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving BREYANZI, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with BREYANZI. Provide supportive care and/or corticosteroids as needed [see DOSAGE AND ADMINISTRATION (2.2, 2.3) and WARNINGS AND PRECAUTIONS (5.2)].
• BREYANZI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the BREYANZI REMS [see WARNINGS AND PRECAUTIONS (5.3)].