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Yescarta
axicabtagene ciloleucel
Black Box Warnings .
Appropriate Use
restricted distribution program (YESCARTA and TECARTUS REMS) due to cytokine release syndrome (CRS) and neurological toxicity risk; admin. only at certified healthcare facility w/ trained healthcare providers to manage CRS and neurological toxicities; certified healthcare facility must have on-site, immediate access to tocilizumab, and a minimum of 2 doses of tocilizumab for each pt w/in 2h after tx if needed; 1-844-454-5483 or www.YescartaTecartusREMS.com for more info
Cytokine Release Syndrome
incl. fatal or life-threatening rxn, occurred; do not admin. if active infection or inflammatory disorders; treat severe or life-threatening CRS w/ tocilizumab +/- corticosteroids; monitor pts at least daily x7 days post-infusion at certified healthcare facility, then monitor s/sx x4wk after tx w/in proximity of certified healthcare facility; counsel pts on s/sx and to seek immediate medical attention if they occur at any time
Neurological Toxicities
incl. fatal or life-threatening rxn, occurred, incl. concurrently w/ CRS or after CRS resolution; provide supportive care and/or corticosteroids as needed; monitor pts at least daily x7 days post-infusion at certified healthcare facility, then monitor s/sx x4wk after tx w/in proximity of certified healthcare facility
Secondary Hematological Malignancies
incl. T-cell malignancies, have occurred; monitor life-long; contact Kite at 1-844-454-5483 to report malignancy occurrence and obtain instructions on pt sample collection
Adult Dosing .
Dosage forms: INJ
Restricted Distribution in US
- [1-844-454-5483 or www.YescartaTecartusREMS.com for more info]
Special Note
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses, premeds, prophylactic antimicrobials, and dosing
follicular lymphoma, relapsed or refractory
- [2 x10^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg/dose IV x1]
- Start: 2 days after completing lymphodepleting combo chemo regimen cyclophosphamide + fludarabine; Max: 2 x10^8 CAR-positive viable T-cells/total dose
large B-cell lymphoma, relapsed or refractory
- [2 x10^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg/dose IV x1]
- Start: 2 days after completing lymphodepleting combo chemo regimen cyclophosphamide + fludarabine; Max: 2 x10^8 CAR-positive viable T-cells/total dose; Info: for pts who are potential autologous HSCT candidate as 2nd-line tx; for pts w/ diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma as 3rd-line and subsequent tx
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.