Generic Name and Formulations:
Axicabtagene ciloleucel (may contain up to 2x108 CAR-positive viable T cells); per dose; susp for IV infusion; contains dimethyl sulfoxide (DMSO) and albumin (human).
Kite Pharma, Inc.
Indications for YESCARTA:
Treatment of adults with relapsed or refractory large B-cell lymphoma after 2 or more lines of systemic therapy, including 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.
Limitations Of use:
Not for treating primary CNS lymphoma.
For autologous and IV use only; confirm patient identity prior to infusion. Give lymphodepleting chemotherapy (cyclophosphamide 500mg/m2 IV + fludarabine 30mg/m2 IV on the 5th, 4th, and 3rd day prior to Yescarta infusion. Premedicate with APAP and diphenhydramine approx. 60mins prior to Yescarta infusion; avoid prophylactic corticosteroids. Infuse contents of bag within 30mins. Target dose: 2x106 CAR-positive viable T cells/kg; max 2x108 CAR-positive viable T cells.
Cytokine release syndrome. Neurologic toxicities.
Increased risk of cytokine release syndrome (CRS); do not give to patients with active infection and/or inflammatory disorders. Have tocilizumab readily available. Monitor at least daily for 7 days at healthcare facility following infusion for signs/symptoms of CRS and neurologic toxicities. Continue to monitor for CRS for 4 weeks after infusion; at 1st sign, institute treatment with supportive care, tocilizumab and/or corticosteroids as indicated (see full labeling). Monitor for neurologic toxicities for 4 weeks after infusion and treat promptly (see full labeling). Monitor for infection, febrile neutropenia; evaluate, manage and treat appropriately. Screen for HBV, HCV, and HIV prior to cell collection for manufacturing. Monitor blood counts, immunoglobulin levels after treatment. Pregnancy: not recommended. Verify pregnancy status prior to starting treatment. Nursing mothers.
CD19-directed genetically modified autologous T cell immunotherapy.
Concomitant live virus vaccines: not recommended for at least 6 weeks prior to lymphodepleting chemotherapy, during Yescarta treatment, and until immune recovery.
CRS, fever, hypotension, encephalopathy, tachycardia, fatigue, headache, decreased appetite, chills, diarrhea, febrile neutropenia, infections-pathogen unspecified, nausea, hypoxia, tremor, cough, vomiting, dizziness, constipation, cardiac arrhythmias; hypersensitivity reactions, HBV reactivation, hypogammaglobulinemia, neurologic toxicities, prolonged cytopenias, secondary malignancies (monitor).
Infusion bag (approx. 68mL)—1