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Treosulfan with fludarabine for malignant disease before allogeneic stem cell transplant

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2 Information about treosulfan

Marketing authorisation indication

2.1 Treosulfan (Trecondi, Medac) in combination with fludarabine (generic) is indicated 'as part of conditioning treatment prior to allogeneic haematopoietic stem cell transplantation (alloHSCT) in adult patients with malignant and non-malignant diseases, and in paediatric patients older than 1 month with malignant diseases'.

2.2 This appraisal focuses on malignant diseases only.

Dosage in the marketing authorisation

2.3 Adults with malignant disease:

  • Treosulfan 10 g/m² body surface area (BSA) per day as a 2‑hour intravenous infusion, given on 3 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 5 consecutive days (day -6, -5, -4, -3, -2) before stem cell infusion (day 0). The total fludarabine dose is 150 mg/m².

2.4 Children with malignant disease:

  • Treosulfan 10 to 14 g/m² BSA per day as a 2‑hour intravenous infusion, given on 3 consecutive days (day -6, -5, -4) before stem cell infusion (day 0). The total treosulfan dose is 30 to 42 g/m².

  • Fludarabine 30 mg/m² BSA per day as a 0.5‑hour intravenous infusion, given on 5 consecutive days (day -7, -6, -5, -4, -3) before stem cell infusion (day 0). The total fludarabine dose is 150 mg/m².

2.5 For full details of dose schedules, see the summary of product characteristics.

Price

2.6 Treosulfan:

  • £494.40 per 5‑vial pack of 1 g powder for solution for injection (BNF online accessed December 2019)

  • £2,434.25 per 5‑vial pack of 5 g powder for solution for injection (BNF online accessed December 2019).

2.7 Fludarabine:

  • £155.00 per vial of 50 mg powder for solution for injection (BNF online accessed November 2019).