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.
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 IV within 30mins. Target dose: 2x106 CAR-positive viable T cells/kg; max 2x108 CAR-positive viable T cells.
For autologous and IV use only; confirm patient identity prior to infusion. Increased risk of cytokine release syndrome (CRS); do not administer if 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. Monitor for CRS for ≥4 weeks after treatment; at 1st sign, manage with supportive care, tocilizumab and/or corticosteroids as indicated (see full labeling). Monitor for neurologic toxicities for ≥4 weeks after treatment; treat promptly with tocilizumab, corticosteroids and/or seizure prophylaxis as indicated (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. Avoid potential transmission of infectious diseases when handling product. Pregnancy: not recommended. Verify pregnancy status prior to starting treatment. Nursing mothers.
Concomitant live virus vaccines: not recommended for ≥6 weeks prior to lymphodepleting chemotherapy, during Yescarta treatment, and until immune recovery.
CD19-directed genetically modified autologous T cell immunotherapy.
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