LEUKAPHERESIS T cells are collected via leukapheresis at a qualified center.1
MANUFACTURING Cells are sent to a manufacturing site for purification, engineering, and expansion delivering a defined ratio of CAR-positive viable T cells (consisting of 1:1 CD8 and CD4 components). Ensure that patients understand the risk (11%) of manufacturing failure. Rates of manufacturing failure in the commercial setting differ from rates in the clinical trial.1
INFUSION Breyanzi is delivered as separate vials of CD8-positive and CD4-positive cells. Lymphodepletion chemotherapy (fludarabine 30 mg/m2/day and cyclophosphamide 300 mg/m2/day concurrently for 3 days) should be completed 2 to 7 days before administration of Breyanzi.1
A single dose of Breyanzi is 90 to 110 × 106 CAR-positive viable T cells for LBCL after 1 line of therapy, and
50 to 110 × 106 for LBCL after 2 or more lines of therapy (consisting of 1:1 CAR-positive viable T cells of the CD8 and CD4 components). The manufacturing target dose is 100 × 106 CAR-positive viable T cells.1
Physician is notified of estimated Breyanzi availability date, which is subject to change. Confirm availability before starting lymphodepletion.
MONITORING Monitor patients daily at a certified healthcare facility during the first week following infusion for signs and symptoms of CRS and neurologic toxicities.
Instruct patients to remain within proximity of the certified healthcare facility for at least 4 weeks following infusion.1
Post-infusion monitoring: After at least 4 weeks of post-infusion monitoring, patients require long-term monitoring and appointments.1
Advise your patients to avoid driving or operating heavy or potentially dangerous machines for at least 8 weeks following their Breyanzi infusion.1
- Continue to monitor for signs and symptoms of CRS and NT. Evaluate and treat promptly
- Continue to monitor CBC and watch for signs and symptoms of serious infections, febrile neutropenia, prolonged cytopenias, B-cell aplasia, hypogammaglobulinemia, and secondary malignancies
- Monitor lifelong for secondary malignancies. In the event that a secondary malignancy occurs, contact Bristol Myers Squibb at 1-888-805-4555 for reporting and instructions
CAR, chimeric antigen receptor; CBC, complete blood counts; CRS, cytokine release syndrome; LBCL, large B-cell lymphoma; NT neurolgic toxicity.
Patients may be enrolled in the Breyanzi registry, which will
monitor safety for up to 15 years. Patients should also be monitored lifelong for potential secondary malignancies