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Kymriah Generic Name & Formulations
Legal Class
Rx
General Description
Tisagenlecleucel (may contain up to 6x108 CAR-positive viable T cells); per dose; susp for IV infusion; contains dimethyl sulfoxide (DMSO) and dextran 40.
Pharmacological Class
CD19-directed genetically modified autologous T cell immunotherapy.
How Supplied
Infusion bag—1
Manufacturer
Generic Availability
NO
Kymriah Indications
Indications
In patients aged ≤25yrs with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. In adults with relapsed or refractory large B-cell lymphoma after ≥2 lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. In adults with relapsed or refractory follicular lymphoma (FL) after ≥2 lines of systemic therapy.
Limitations of Use
Not for treating primary CNS lymphoma.
Kymriah Dosage and Administration
Adults and Children
For autologous and IV use only; confirm patient identity prior to infusion. Premedicate with APAP and diphenhydramine or other H1-antihistamine approx. 30–60mins prior to Kymriah infusion; avoid prophylactic corticosteroids. Infuse IV at rate of 10–20mL/min. ALL: >25yrs: not established. 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. ≤25yrs (≤50kg): 0.2–5x106 CAR-positive viable T cells/kg; (>50kg): 0.1–2.5x108 CAR-positive viable T cells. DLBCL and FL: <18yrs: not established. Give lymphodepleting chemotherapy (fludarabine 25mg/m2 IV daily for 3 days + cyclophosphamide 250mg/m2 IV daily for 3 days or bendamustine 90mg/m2 IV daily for 2 days) 2–11 days (DLBCL) or 2–6 days (FL) prior to Kymriah infusion; omit if WBC ≤1x109/L within 1 week prior. ≥18yrs: 0.6–6x108 CAR-positive viable T cells.
Kymriah Contraindications
Not Applicable
Kymriah Boxed Warnings
Boxed Warning
Cytokine release syndrome. Neurological toxicities.
Kymriah Warnings/Precautions
Warnings/Precautions
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.
REMS
Kymriah Pharmacokinetics
See Literature
Kymriah Interactions
Interactions
Myeloid growth factors (eg, GM-CSF): not recommended during first 3 weeks post-infusion or until CRS resolved. Live virus vaccines: not recommended for ≥6 weeks prior to lymphodepleting chemotherapy, during Kymriah treatment, and until immune recovery. May yield false (+) results with certain HIV nucleic acid tests.
Kymriah Adverse Reactions
Adverse Reactions
CRS, hypogammaglobulinemia, infections-pathogen unspecified, pyrexia, decreased appetite, headache, encephalopathy, hypotension, bleeding episodes, tachycardia, nausea, diarrhea, vomiting, viral infections, hypoxia, fatigue, acute kidney injury, edema, cough, delirium, musculoskeletal pain; hypersensitivity reactions, HBV reactivation, neurological events, hemophagocytic lymphohistiocytosis/macrophage activation syndrome, prolonged cytopenias, secondary malignancies (monitor).
Kymriah Clinical Trials
See Literature
Kymriah Note
Notes
To register pregnant patients, call (888) 669-6682.
Kymriah Patient Counseling
See Literature
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