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).
Adult Dosage:
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.
Children Dosage:
Not established.
Boxed Warning:
Cytokine release syndrome (CRS). Neurologic toxicities.
TECARTUS Warnings/Precautions:
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.
TECARTUS Classification:
CD19-directed genetically modified autologous T cell immunotherapy.
TECARTUS Interactions:
Concomitant live virus vaccines: not recommended for ≥6 weeks prior to lymphodepleting chemotherapy, during Tecartus treatment, and until immune recovery.
Adverse Reactions:
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.
Note:
Available only through a restricted REMS Program. For more information visit www.YescartaTecartusREMS.com or call (844) 454-5483.
REMS:
Generic Drug Availability:
NO
How Supplied:
Infusion bag (approx. 68mL)—1
