Carvykti

Increased early mortality. Risk for CRS; do not give to those with active infection and/or inflammatory disorders. Have tocilizumab and emergency equipment readily available. Monitor at least daily for 10 days at the healthcare facility following infusion for signs/symptoms of CRS and neurologic toxicities. Continue to monitor for CRS for 4 weeks after infusion; at 1^st sign, institute treatment with supportive care, tocilizumab and/or corticosteroids as indicated (see full labeling). Risk for neurologic toxicities including immune effector cell-associated neurotoxicity syndrome, parkinsonism, Guillain-Barré syndrome, peripheral neuropathies, cranial nerve palsies. Monitor for neurologic toxicities for 4 weeks after infusion and treat promptly (see full labeling). Evaluate for HLH/MAS if CRS or neurologic toxicities occur. Monitor for infection, febrile neutropenia; evaluate, manage and treat appropriately. Screen for CMV, HBV, HCV, and HIV prior to cell collection for manufacturing. Monitor blood counts (prior to and after initiation), immunoglobulin levels after treatment. Monitor for severe hypersensitivity reactions for 2hrs after infusion. Hepatic or renal impairment: not studied. Pregnancy: not recommended. Verify pregnancy status prior to initiation. Nursing mothers.