Active Ingredient: Tisagenlecleucel
Tisagenlecleucel is indicated for the treatment of paediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse.
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
200,000 - 5,000,000 [CCID_50] per kg of body weight
From 200,000 To 5,000,000 [CCID_50] per kg of body weight once every day
Tisagenlecleucel must be administered in a qualified treatment centre. Therapy should be initiated under the direction of and supervised by a healthcare professional experienced in the treatment of haematological malignancies and trained for administration and management of patients treated with tisagenlecleucel. A minimum of four doses of tocilizumab for use in the event of cytokine release syndrome and emergency equipment must be available prior to infusion.
Tisagenlecleucel is intended for autologous use only. Manufacture and release of tisagenlecleucel usually takes about 3-4 weeks.
Dosage in paediatric and young adult B-cell ALL patients:
Lymphodepleting chemotherapy is recommended to be administered before tisagenlecleucel infusion unless the white blood cell (WBC) count within one week prior to infusion is ≤1,000 cells/μL. Tisagenlecleucel is recommended to be infused 2 to 14 days after completion of the lymphodepleting chemotherapy. The availability of tisagenlecleucel must be confirmed prior to starting the lymphodepleting regimen. If there is a delay of more than 4 weeks between completing lymphodepleting chemotherapy and the infusion and the WBC count is >1,000 cells/μL, then the patient should be re-treated with lymphodepleting chemotherapy prior to receiving tisagenlecleucel.
The recommended lymphodepleting chemotherapy regimen is:
To minimise potential acute infusion reactions, it is recommended that patients be pre-medicated with paracetamol and diphenhydramine or another H1 antihistamine within approximately 30 to 60 minutes prior to tisagenlecleucel infusion. Corticosteroids should not be used at any time except in the case of a life-threatening emergency.
Tisagenlecleucel treatment should be delayed in some patient groups at risk.
Patients should be monitored daily for the first 10 days following infusion for signs and symptoms of potential cytokine release syndrome, neurological events and other toxicities. Physicians should consider hospitalisation for the first 10 days post infusion or at the first signs/symptoms of cytokine release syndrome and/or neurological 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.
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