Treosulfan is given in combination with fludarabine.
The recommended dose and schedule of administration is:
- Treosulfan 10 g/m² body surface area (BSA) per day as a two-hour intravenous infusion, given on three consecutive days (day -4, -3, -2) before stem cell infusion (day 0). The total treosulfan dose is 30 g/m²;
- Fludarabine 30 mg/m² BSA per day as a 0.5-hour intravenous infusion, given on five consecutive days (day -6, -5, -4, -3, -2) before stem cell infusion (day 0). The total fludarabine dose is 150 mg/m²;
- Treosulfan should be administered before fludarabine on days -4, -3, -2 (FT 10 regimen).
Health Canada has not authorized the use of Treosulfan in children less than 1 year of age.
No dose adjustment is necessary for mild or moderate liver or renal impairment, but treosulfan is contraindicated in patients with severe impairment.
Pediatrics (>1 year to 18 years): The use of Treosulfan has not been fully investigated in the pediatric population.
Geriatrics: Eighty-one (13.2%) of the 613 adult patients treated within the clinical trial program for Treosulfan were above the age of 65 years.
Hepatic Insufficiency: No pharmacokinetic studies with treosulfan were conducted in patients with severe hepatic impairment, because such patients are generally excluded from alloHSCT.
Renal Insufficiency: No pharmacokinetic studies with treosulfan were conducted in patients with severe renal impairment.
