Primary mediastinal large B-cell lymphoma (PMBCL)

Αxicabtagene ciloleucel is intended for autologous use only.

A single dose of axicabtagene ciloleucel contains 2 × 10⁶ CAR-positive viable T cells per kg of body weight (or maximum of 2 × 10⁸ CAR-positive viable T cells for patients 100 kg and above) in approximately 68 mL dispersion in an infusion bag.

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 intravenous and fludarabine 30 mg/m² intravenous should be administered on the 5^th, 4^th, and 3^rd day before infusion of axicabtagene ciloleucel.

Pre-medication

• Paracetamol 500-1,000 mg given orally and diphenhydramine 12.5 to 25 mg intravenous or oral (or equivalent) approximately 1 hour before axicabtagene ciloleucel infusion is recommended.
• Prophylactic use of systemic corticosteroids is not recommended as it may interfere with the activity of axicabtagene ciloleucel.

Monitoring

• Patients should be monitored daily for the first 10 days following infusion for signs and symptoms of potential CRS, neurologic events and other toxicities. Physicians should consider hospitalisation for the first 10 days post infusion or at the first signs or symptoms of CRS and/or neurologic events.
• After the first 10 days following the infusion, the patient should be monitored at the physician’s discretion.
• Patients should be instructed to remain within proximity of a qualified clinical facility for at least 4 weeks following infusion.