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Carvykti
ciltacabtagene autoleucel
Black Box Warnings .
Cytokine Release Syndrome
incl. fatal or life-threatening rxn, occurred; do not admin. if active infection or inflammatory disorders; confirm minimum 2 doses tocilizumab avail. prior to infusion; treat severe or life-threatening CRS w/ tocilizumab +/- corticosteroids; monitor pts at least daily x7 days post-infusion, then monitor s/sx for at least 2wk after tx w/in proximity of healthcare facility; counsel pts on s/sx and to seek immediate medical attention if they occur at any time
Immune Effector Cell-Associated Neurotoxicity Syndrome
which may be fatal or life-threatening, occurred, incl. before CRS onset, concurrently w/ CRS, after CRS resolution, or in the absence of CRS; provide supportive care, and/or corticosteroids, levetiracetam as needed; monitor pts at least daily x7 days post-infusion, then monitor s/sx for at least 2wk after tx w/in proximity of healthcare facility; counsel pts on s/sx and to seek immediate medical attention if they occur at any time
Parkinsonism and Guillain-Barre Syndrome
and associated complications resulting in fatal or life-threatening rxn occurred; provide supportive care; consider immunoglobulins and plasma exchange for Guillain-Barre syndrome, depending on severity
Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome
incl. fatal or life-threatening rxn, occurred; can occur w/ CRS or neurologic toxicities
Cytopenias
incl. prolonged and/or recurrent cytopenias w/ bleeding and infection, requiring stem cell transplantation for hematopoietic recovery
Secondary Hematological Malignancies
incl. myelodysplastic syndrome, AML, T-cell malignancies, have occurred; monitor life-long; contact Janssen Biotech at 1-800-526-7736 to report malignancy occurrence and obtain instructions on pts sample collection
Adult Dosing .
Dosage forms: INJ
Special Note
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses, premeds, prophylactic antimicrobials, and dosing
multiple myeloma, relapsed or refractory
- [0.5-1 x10^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg/dose IV x1]
- Max: 1 x10^8 CAR-positive viable T-cells/total dose; Start: 2-4 days after completing lymphodepleting combo chemo regimen cyclophosphamide + fludarabine; Info: for pts who have received at least 1 prior tx incl. a proteasome inhibitor and an immunomodulatory agent, and who are refractory to lenalidomide
renal dosing
- [see below]
- CrCl >60: no adjustment; CrCl <60: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- mild impairment: no adjustment; moderate-severe impairment: not defined
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.