Leukemias, lymphomas, and other hematologic cancers:
Indications for: BREYANZI
Treatment of adults with large B-cell lymphoma (LBCL), 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 who have: refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age; or relapsed or refractory disease after ≥2 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 300mg/m2/day IV + fludarabine 30mg/m2/day 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. Relapsed/refractory after 1 line of therapy: give a single dose of 90–110×106 CAR-positive viable T cells (consisting of 1:1 CD8 and CD4 components), with each component supplied separately. Relapsed/refractory after ≥2 lines of therapy: give a single dose of 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.
Cytokine release syndrome. Neurologic toxicities.
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. Consider concurrent antiviral therapy to prevent HBV reactivation in those with prior history of HBV. Monitor CBCs (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 Breyanzi treatment, and until immune recovery. May cause false (+) results in certain HIV nucleic acid tests.
Fatigue, fever, 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).
Available only through a restricted REMS Program. For more information visit www.BreyanziREMS.com or call (888) 423-5436.
Generic Drug Availability:
Single-dose vials (5mL)—1, 2×4