brexucabtagene autoleucel: clinical use

Prescribing considerations

• Use only in a qualified centre experienced in haematological malignancy and CAR T-cell toxicities.
• Confirm patient identity at every handling and administration stage; the product is strictly autologous.
• Screen for HIV, hepatitis B and hepatitis C before cell collection.
• Consider delaying infusion for active uncontrolled infection or inflammation, active graft-versus-host disease or unresolved serious toxicity from previous treatment.
• Confirm CD19 status; treatment is not recommended for CD19-negative disease.
• Assess tumour burden, tumour lysis risk, organ function, neurological history and infection risk.
• Ensure immediate access to cytokine release syndrome treatment and emergency support.
• Arrange long-term follow-up for secondary malignancies.

Contraindications and cautions

• Hypersensitivity to brexucabtagene autoleucel or an excipient.
• Any contraindication to the required lymphodepleting chemotherapy must also be considered.
• Active graft-versus-host disease, active uncontrolled infection and significant unresolved toxicity are reasons to defer treatment rather than absolute product contraindications.
• Evidence is limited in active CNS lymphoma and significant CNS, renal, hepatic, pulmonary or cardiac disease.

Monitoring

• Monitor closely for cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome.
• Monitor temperature, vital signs, oxygenation, neurological status and organ function according to clinical risk.
• Check full blood counts for prolonged cytopenias.
• Monitor for bacterial, viral and fungal infection, including reactivation where relevant.
• Monitor immunoglobulin levels and consider infection precautions or replacement therapy where clinically indicated.
• Monitor tumour lysis markers in at-risk patients.
• Maintain lifelong surveillance for secondary malignancies.

Clinical pharmacology

An autologous anti-CD19 CAR T-cell therapy using a retroviral vector. CD19 binding activates CD28 and CD3-zeta signalling, promoting T-cell activation, proliferation, cytokine release and killing of CD19-expressing cells. Cellular expansion and persistence vary between patients.

Formulation and product differences

• Supplied as a patient-specific frozen dispersion for intravenous infusion in one cryostorage bag.
• Cell concentration is batch-dependent.
• The dispersion may appear clear to opaque and white to red.
• Excipients include CryoStor CS10 containing dimethyl sulfoxide, sodium chloride and human albumin; residual gentamicin may be present.
• Do not irradiate, refreeze after thawing, mix with other medicines or administer through a leukodepleting filter.