Generic Name and Formulations:
Tisagenlecleucel (may contain up to 2.5x108 CAR-positive viable T cells); per dose; susp for IV infusion; contains dimethyl sulfoxide (DMSO) and dextran 40.
Novartis Pharmaceuticals Corp
Indications for KYMRIAH:
Treatment of B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse in patients aged ≤25yrs.
Adults and Children:
Give lymphodepleting chemotherapy (fludarabine 30mg/m2 IV daily for 4 days + cyclophosphamide 500mg/m2 IV daily for 2 days) 2–14 days prior to Kymriah infusion. Premedicate with APAP and diphenhydramine or other H1-antihistamine approx. 30–60mins prior to Kymriah infusion; do not use corticosteroids at any time unless life-threatening emergency. Infuse IV at rate of 10–20mL/min. >25yrs: not established. ≤25yrs (≤50kg): administer 0.2–5.0x106 CAR-positive viable T cells/kg; (>50kg): administer 0.1–2.5x108 CAR-positive viable T cells.
For autologous and IV use only; confirm patient identity prior to infusion. Increased risk of severe cytokine release syndrome (CRS) in high pre-infusion tumor burden, uncontrolled or accelerating tumor burden post-lymphodepleting chemotherapy, active infections, and/or inflammatory processes. Delay Kymriah infusion after lymphodepleting chemotherapy if unresolved serious adverse reactions from preceding chemotherapies (eg, pulmonary or cardiac toxicity, hypotension), active uncontrolled infection, active GVHD, or worsening of leukemia burden. Have tocilizumab readily available. Monitor for CRS for ≥4 weeks after treatment; if suspected, manage with supportive care, tocilizumab and/or corticosteroids as indicated (see full labeling). Monitor for neurological events, infection, febrile neutropenia; manage and treat appropriately. Screen for HBV, HCV, and HIV prior to cell collection for manufacturing. Monitor immunoglobulin levels post-treatment; assess newborns of mothers treated with Kymriah. Avoid potential transmission of infectious diseases when handling product. Elderly: not established. Pregnancy: not recommended. Verify pregnancy status prior to starting treatment. Nursing mothers.
Myeloid growth factors (eg, GM-CSF): not recommended during first 3 weeks post-infusion or until CRS resolved. Live virus vaccines: not recommended for ≥2 weeks prior to lymphodepleting chemotherapy, during Kymriah treatment, and until immune recovery. May yield false (+) results with certain HIV nucleic acid tests.
CD19-directed genetically modified autologous T cell immunotherapy.
CRS, hypogammaglobulinemia, infections-pathogen unspecified, pyrexia, decreased appetite, headache, encephalopathy, hypotension, bleeding episodes, tachycardia, nausea, diarrhea, vomiting, viral infections, hypoxia, fatigue, acute kidney injury, delirium; hypersensitivity reactions, HBV reactivation, neurological events, prolonged cytopenias, secondary malignancies (monitor).
To register pregnant patients, call (888) 669-6682.
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