Leukemias, lymphomas, and other hematologic cancers:
Indications for: TECARTUS
In adults with relapsed or refractory mantle cell lymphoma (MCL). In adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
For autologous and IV use only; confirm patient identity prior to infusion. Do not use a leukodepleting filter. Premedicate with APAP and diphenhydramine or other H1-antihistamine approx. 30–60mins prior to Tecartus infusion; avoid prophylactic corticosteroids. MCL: Give lymphodepleting chemotherapy (cyclophosphamide 500mg/m2 IV + fludarabine 30mg/m2 IV) on the 5th, 4th, and 3rd days prior to Tecartus infusion. Infuse contents of bag within 30mins. 2×106 CAR-positive viable T cells/kg; max 2×108 CAR-positive viable T cells. ALL: Give lymphodepleting chemotherapy of fludarabine 25mg/m2 IV on the 4th, 3rd, and 2nd day, and give cyclophosphamide 900mg/m2 IV on the 2nd day prior to Tecartus infusion. Infuse contents of bag within 30mins. 1×106 CAR-positive viable T cells/kg; max 1×108 CAR-positive viable T cells. Management of severe adverse reactions: see full labeling.
Cytokine release syndrome (CRS). Neurologic toxicities.
Risk of CRS; do not give to patients with active infection and/or inflammatory disorders. Have tocilizumab and emergency equipment readily available. Monitor daily for at least 7 days (with MCL) and at least 14 days (with ALL) at the healthcare facility following infusion for 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). Immunosuppressed. 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 (prior to and after initiation), immunoglobulin levels after treatment. Pregnancy: not recommended. Verify pregnancy status prior to initiation. Nursing mothers.
CD19-directed genetically modified autologous T cell immunotherapy.
Concomitant live virus vaccines: not recommended for ≥6 weeks prior to lymphodepleting chemotherapy, during Tecartus treatment, and until immune recovery.
Pyrexia, CRS, hypotension, encephalopathy, fatigue, tachycardia, arrhythmia, infection (pathogen unspecified), chills, hypoxia, cough, tremor, musculoskeletal pain, headache, nausea, edema, motor dysfunction, constipation, diarrhea, decreased appetite, dyspnea, rash, insomnia, pleural effusion, aphasia, febrile neutropenia, vomiting; hypersensitivity reactions, hypogammaglobulinemia, neurologic events, prolonged cytopenias, secondary malignancies (monitor life-long), hemophagocytic lymphohistiocytosis/macrophage activation syndrome.
Available only through a restricted REMS Program. For more information visit www.YescartaTecartusREMS.com or call (844) 454-5483.
Generic Drug Availability:
Infusion bag (approx. 68mL)—1