High-grade B-cell lymphoma (HGBL)

Axicabtagene ciloleucel is intended for autologous use.

Treatment consists of a single dose for infusion containing a dispersion for infusion of CAR-positive viable T cells in one infusion bag. The target dose is 2 × 10⁶ CAR-positive viable T cells per kg of body weight (within a range of 1 × 10⁶ – 2 × 10⁶ cells/kg), with a maximum of 2 × 10⁸ CAR-positive viable T cells for patients 100 kg and above.

The availability of axicabtagene ciloleucel must be confirmed prior to starting the lymphodepleting regimen.

Pre-treatment (lymphodepleting chemotherapy):

• A lymphodepleting chemotherapy regimen consisting of cyclophosphamide 500 mg/m² intravenously and fludarabine 30 mg/m² intravenously must be administered prior to infusing axicabtagene ciloleucel. The recommended days are on the 5^th, 4^th, and 3^rd day before infusion of axicabtagene ciloleucel.

Pre-medication:

• It is recommended that pre-medication with paracetamol 500-1 000 mg given orally and diphenhydramine 12.5 to 25 mg intravenously or orally, or equivalent medicinal products, be administered approximately 1 hour before the infusion of axicabtagene ciloleucel to reduce the possibility of an infusion reaction.
• Prophylactic use of systemic corticosteroids is not recommended.

Monitoring:

• Patients must be monitored daily for the first 7 days following infusion for signs and symptoms of potential CRS, neurologic events and other toxicities. Physicians can consider hospitalisation for the first 7 days or at the first signs or symptoms of CRS and/or neurologic events.
• After the first 7 days following the infusion, the patient is to be monitored at the physician’s discretion.
• Patients must remain within proximity of a qualified clinical facility for at least 4 weeks following infusion.

Axicabtagene ciloleucel is to be administered via intravenous infusion.

Axicabtagene ciloleucel must not be irradiated. A leukodepleting filter must not be used.

Tocilizumab and emergency equipment must be available prior to infusion and during the monitoring period. In the exceptional case where tocilizumab is not available due to a shortage that is listed in the European Medicines Agency shortage catalogue, suitable alternative measures to treat CRS instead of tocilizumab must be available prior to infusion.