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, 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)].
Approved Risk Evaluation and Mitigation Strategies (REMS)
Patient Counseling Information