Leukemias, lymphomas, and other hematologic cancers:

Indications for: BREYANZI

Treatment of 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 (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.

Limitations of Use:

Not for treating primary CNS lymphoma.

Adult Dosage:

For autologous and IV use only; confirm patient identity prior to infusion. Do not use a leukodepleting filter. Give lymphodepleting chemotherapy (cyclophosphamide 300mg/m2 IV + fludarabine 30mg/m2 IV) for 3 days. Premedicate with APAP and diphenhydramine or other H1-antihistamine approx. 30–60mins prior to Breyanzi infusion; avoid prophylactic corticosteroids. Infuse Breyanzi 2–7 days after lymphodepleting chemotherapy. Give 50–110×106 CAR-positive viable T cells (consisting of 1:1 CD8 and CD4 components), with each component supplied separately. May need >1 vial per component to achieve target dose. For dose preparation/administration and management of severe adverse reactions: see full labeling.

Children Dosage:

Not established.

Boxed Warning:

Cytokine release syndrome. Neurologic toxicities.

BREYANZI 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 (prior to and after initiation), immunoglobulin levels after treatment. Pregnancy: not recommended. Verify pregnancy status prior to initiation. Nursing mothers.

BREYANZI Classification:

CD19-directed genetically modified autologous T cell immunotherapy.

BREYANZI Interactions:

Concomitant live virus vaccines: not recommended for ≥6 weeks prior to lymphodepleting chemotherapy, during Breyanzi treatment, and until immune recovery. May cause false (+) results in certain HIV nucleic acid tests.

Adverse Reactions:

Fatigue, CRS, musculoskeletal pain, nausea, headache, encephalopathy, infections (pathogen unspecified), decreased appetite, diarrhea, hypotension, tachycardia, dizziness, cough, constipation, abdominal pain, vomiting, edema; hypersensitivity reactions, HBV reactivation, hypogammaglobulinemia, neurologic toxicities, prolonged cytopenias, secondary malignancies (monitor).

Note:

Available only through a restricted REMS Program. For more information visit www.BreyanziREMS.com or call (888) 423-5436.

REMS:

YES

Generic Drug Availability:

NO

How Supplied:

Single-dose vials (5mL)—1, 2×4

Pricing for BREYANZI

1 vial of 4.6ml carton (Qty: 1)
Appx. price $418515
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