Leukemias, lymphomas, and other hematologic cancers:

Indications for TECARTUS:

Treatment of adults with relapsed or refractory mantle cell lymphoma (MCL).

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 Tecartus infusion. Premedicate with APAP and diphenhydramine or other H1-antihistamine approx. 30–60mins prior to Tecartus infusion; avoid prophylactic corticosteroids. Infuse contents of bag within 30mins. 2×106 CAR-positive viable T cells/kg; max 2×108 CAR-positive viable T cells.

Children:

Not established.

Boxed Warning:

Cytokine release syndrome. Neurologic toxicities.

Warnings/Precautions:

Risk of cytokine release syndrome (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 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, 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). 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, immunoglobulin levels after treatment. Pregnancy: not recommended. Verify pregnancy status prior to initiation. Nursing mothers.

Pharmacologic Class:

CD19-directed genetically modified autologous T cell immunotherapy.

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; hypersensitivity reactions, HBV reactivation, hypogammaglobulinemia, neurologic events, prolonged cytopenias, secondary malignancies (monitor).

Note:

Available only through a restricted REMS Program. For more information visit www.YescartaTecartusREMS.com or call (844) 454-5483.

REMS:

YES

Generic Availability:

NO

How Supplied:

Infusion bag (approx. 68mL)—1