Leukemias, lymphomas, and other hematologic cancers:
Indications for: YESCARTA
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.
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.
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 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.
CD19-directed genetically modified autologous T cell immunotherapy.
Concomitant live virus vaccines: not recommended for ≥6 weeks prior to lymphodepleting chemotherapy, during Yescarta treatment, and until immune recovery.
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).
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