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Yescarta Generic Name & Formulations
Legal Class
Rx
General Description
Axicabtagene ciloleucel (contains max of 2×10^8 CAR-positive viable T cells); per infusion bag; cell susp for IV infusion; contains dimethyl sulfoxide (DMSO) and albumin (human).
Pharmacological Class
CD19-directed genetically modified autologous T cell immunotherapy.
How Supplied
Infusion bag (approx. 68mL)—1
Manufacturer
Generic Availability
NO
Mechanism of Action
Axicabtagene ciloleucel binds to CD19-expressing cancer cells and normal B cells. Studies demonstrated that following anti-CD19 CAR T cell engagement with CD19-expressing target cells, the CD28 and CD3-zeta co-stimulatory domains activate downstream signaling cascades that lead to T cell activation, proliferation, acquisition of effector functions and secretion of inflammatory cytokines and chemokines. This sequence of events leads to killing of CD19-expressing cells.
Yescarta Indications
Indications
In adults with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. In 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. In adults with relapsed or refractory follicular lymphoma (FL) after 2 or more lines of systemic therapy.
Limitations of Use
Not for treating primary CNS lymphoma.
Yescarta Dosage and Administration
Adult
For autologous and IV use only; confirm patient identity prior to infusion. Do not use a leukodepleting filter. Give lymphodepleting chemotherapy (cyclophosphamide 500mg/m2 IV + fludarabine 30mg/m2 IV) on the 5th, 4th, and 3rd days prior to Yescarta infusion. Premedicate with APAP and diphenhydramine approx. 60mins prior to Yescarta infusion. Consider use of prophylactic corticosteroids after weighing benefits/risks. Infuse contents of bag within 30mins. Target dose: 2×106 CAR-positive viable T cells/kg; max 2×108 CAR-positive viable T cells. Management of severe adverse reactions: see full labeling.
Children
Not established.
Yescarta Contraindications
Not Applicable
Yescarta Boxed Warnings
Boxed Warning
Cytokine release syndrome (CRS). Neurologic toxicities.
Yescarta Warnings/Precautions
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 at least daily for 7 days at the healthcare facility following infusion for signs/symptoms of CRS and neurologic toxicities. Continue to monitor for CRS for 4 weeks after infusion; at 1st sign, provide supportive care, tocilizumab and/or corticosteroids as indicated. Monitor for neurologic toxicities for 4 weeks after infusion and treat promptly. 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.
REMS
Yescarta Pharmacokinetics
See Literature
Yescarta Interactions
Interactions
Concomitant live virus vaccines: not recommended for ≥6 weeks prior to lymphodepleting chemotherapy, during Yescarta treatment, and until immune recovery.
Yescarta Adverse Reactions
Adverse Reactions
CRS, fever, hypotension, encephalopathy, tachycardia, fatigue, headache, decreased appetite, chills, diarrhea, febrile neutropenia, infections-pathogen unspecified, nausea, hypoxia, tremor, musculoskeletal pain, cough, vomiting, dizziness, constipation, cardiac arrhythmias; hypersensitivity reactions, hypogammaglobulinemia, neurologic toxicities, prolonged cytopenias, secondary malignancies (monitor).
Yescarta Clinical Trials
See Literature
Yescarta Note
Notes
Available only through a restricted REMS Program. For more information visit www.YescartaTecartusREMS.com or call (844) 454-5483.
Yescarta Patient Counseling
See Literature
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