Cytokine Release Syndrome and Neurologic Toxicities

Cytokine Release Syndrome

• Cytokine Release Syndrome (CRS), including life-threatening reactions, occurred in patients receiving TECARTUS. Do not administer TECARTUS to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids [see DOSAGE AND ADMINISTRATION (2.2, 2.3), WARNINGS AND PRECAUTIONS (5.1)].

Neurologic Toxicities

• Neurologic toxicities, including life-threatening reactions, occurred in patients receiving TECARTUS, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with TECARTUS. Provide supportive care and/or corticosteroids as needed [see DOSAGE AND ADMINISTRATION (2.2, 2.3), WARNINGS AND PRECAUTIONS (5.2)].

TECARTUS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the YESCARTA and TECARTUS REMS Program [see WARNINGS AND PRECAUTIONS (5.3)].