Linvoseltamab-gcpt causes the release of cytokines [see Clinical Pharmacology (12.2) ] that may suppress cytochrome P450 (CYP) enzyme activity .
Source: FDA drug label - linvoseltamab-gcpt
Brand names: Lynozyfic
Bispecific B Cell Maturation Antigen-directed CD3 T Cell Engager · B Cell Maturation Antigen-directed Antibody Interactions · CD3-directed Antibody Interactions · CD3 Receptor Agonists
FDA Black Box Warning
WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGIC TOXICITY, INCLUDING IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving LYNOZYFIC. Initiate treatment with LYNOZYFIC step-up dosing to reduce the risk of CRS. Manage CRS, withhold LYNOZYFIC until CRS resolves, and modify the next dose or permanently discontinue based on severity [see Dosage and Administration (2.2 , 2.4 , 2.5) and Warnings and Precautions (5.1) ]. Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), including serious or life-threatening reactions, can occur in patients receiving LYNOZYFIC. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS during treatment. Manage neurologic toxicity, including ICANS, withhold LYNOZYFIC until neurologic toxicity, including ICANS resolves, and modify the next dose or permanently discontinue based on severity [see Dosage and Administration (2.2 , 2.4 , 2.5) and Warnings and Precautions (5.2) ]. Because of the risk of CRS and neurologic toxicity, including ICANS, LYNOZYFIC is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the LYNOZYFIC REMS [see Warnings and Precautions (5.3) ]. WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY, including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME See full prescribing information for complete boxed warning. Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving LYNOZYFIC. Initiate treatment with LYNOZYFIC step-up dosing to reduce the risk of CRS. Manage CRS, withhold LYNOZYFIC until CRS resolves and modify the next dose or permanently discontinue based on severity. ( 2.2 , 2.4 , 2.5 , 5.1 ) Neurologic Toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), including serious or life-threate
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Linvoseltamab-gcpt causes the release of cytokines [see Clinical Pharmacology (12.2) ] that may suppress cytochrome P450 (CYP) enzyme activity .
Source: FDA drug label - linvoseltamab-gcpt