TRECONDI POWDER FOR SOLUTION FOR INFUSION 1 G PER VIAL

INJECTION, POWDER, FOR SOLUTION

**4.2 Posology and method of administration** Administration of treosulfan should be supervised by a physician experienced in conditioning treatment followed by alloHSCT. Posology _Adults with AML and MDS_ 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 (FT10 regimen). _Elderly_ No dose adjustment is necessary in any subset of the elderly population. _Renal and hepatic impairment_ No dose adjustment is necessary for mild or moderate impairment, but treosulfan is contraindicated in patients with severe impairment (see section 4.3). _Paediatric population_ Treosulfan is given in combination with fludarabine, with thiotepa (intensified regimen; FT10–14TT regimen) or without thiotepa (FT10–14 regimen). The recommended dose and schedule of administration is: - Treosulfan 10–14 g/m² body surface area (BSA) per day as a two-hour intravenous infusion, given on three consecutive days (day -6, -5, -4) before stem cell infusion (day 0). The total treosulfan dose is 30–42 g/m²; The dose of treosulfan should be adapted to the patient’s BSA as follows (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_):  - Fludarabine 30 mg/m² BSA per day as a 0.5-hour intravenous infusion, given on five consecutive days (day -7, -6, -5, -4, -3) before stem cell infusion (day 0). The total fludarabine dose is 150 mg/m²; - Treosulfan should be administered before fludarabine; - Thiotepa (intensified regimen 5 mg/kg twice a day), given as two intravenous infusions over 2– 4 hours on day -2 before stem cell infusion (day 0). The safety and efficacy of treosulfan in children less than 1 month of age has not yet been established. Method of administration Treosulfan is for intravenous use as a two-hour infusion. _Precautions to be taken before handling or administering the medicinal product_ When handling treosulfan, inhalation, skin contact or contact with mucous membranes should be avoided. Pregnant personnel should be excluded from handling cytotoxics. Intravenous administration should be performed using a safe technique to avoid extravasation (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). For instructions on reconstitution of the medicinal product before administration, see section 6.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.