Active Ingredient: Nelarabine
Nelarabine is indicated for the treatment of patients with T-cell acute lymphoblastic leukaemia (T-ALL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
650 - 650 mg per m² of body surface area (BSA)
From 650 To 650 mg per m² of body surface area (BSA) once every day for 5 day(s)
The recommended dose of nelarabine for children and adolescents (aged 21 years and younger) is 650 mg/m² administered intravenously over one hour daily for 5 consecutive days, repeated every 21 days.
In clinical studies, the 650 mg/m² and 1,500 mg/m² dose have both been used in patients in the age range 16 to 21 years. Efficacy and safety were similar for both regimens. The prescribing physician should consider which regimen is appropriate when treating patients in this age range.
Limited clinical pharmacology data are available for patients below the age of 4 years.
Nelarabine must be discontinued at the first sign of neurological events of National Cancer Institute Common Terminology Criteria Adverse Event (NCI CTCAE) grade 2 or greater. Delaying subsequent dosing is an option for other toxicities, including haematological toxicity.
It should be administered intravenously as a one-hour infusion.
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