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Cytokine Release Syndrome and Neurological Toxicities

  • Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving KYMRIAH. Do not administer KYMRIAH to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids 
  • Neurological toxicities, which may be severe or life-threatening, can occur following treatment with KYMRIAH, including concurrently with CRS. Monitor for neurological events after treatment with KYMRIAH. Provide supportive care as needed 
  • KYMRIAH is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the KYMRIAH REMS 

Approved Risk Evaluation and Mitigation Strategies (REMS)

KYMRIAH (Tisagenlecleucel) injection

Patient Counseling Information


Medication Guides

Patient Medication Guide

Package Inserts


Additional Information


Updated May 2018