Conditioning treatment prior to conventional haematopoietic progenitor cell transplantation

Active Ingredient: Busulfan

Indication for Busulfan

Population group: only infants (40 days - 1 year old) , children (1 year - 12 years old) , adolescents (12 years - 18 years old)

Busulfan followed by cyclophosphamide (BuCy2) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation (HPCT) in adult patients when the combination is considered the best available option.

Busulfan following fludarabine (FB) is indicated as conditioning treatment prior to haematopoietic progenitor cell transplantation (HPCT) in adult patients who are candidates for a reduced-intensity conditioning (RIC) regimen.

Busulfan followed by cyclophosphamide (BuCy4) or melphalan (BuMel) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in paediatric patients.

For this indication, competent medicine agencies globally authorize below treatments:

3.2-4.8 mg/kg in 4 divided doses daily

Route of admnistration

Intravenous

Defined daily dose

3.2 - 4.8 mg per kg of body weight

Dosage regimen

From 0.8 To 1.2 mg per kg of body weight 4 time(s) per day every day for 4 day(s)

Detailed description

Busulfan in combination with cyclophosphamide or melphalan

Paediatric population (0 to 17 years)

The recommended dose of busulfan is as follows:

Actual body weight (kg) Busulfan dose (mg/kg)
<91.0
9 to <161.2
16 to 231.1
>23 to 340.95
>340.8

followed by:

  • 4 cycles of 50 mg/kg body weight (BW) cyclophosphamide (BuCy4) or
  • one administration of 140 mg/m² melphalan (BuMel) initiated for at least 24 hours following the 16th dose of busulfan.

Busulfan is administered as a two-hour infusion every 6 hours over 4 consecutive days for a total of 16 doses prior to cyclophosphamide or melphalan and haematopoietic progenitor cell transplantation (HPCT).

Dosage considerations

Busulfan should be administered by intravenous infusion via central venous catheter. Busulfan should not be given by rapid intravenous, bolus or peripheral injection.

120-150 mg/m² in 4 divided doses daily

Route of admnistration

Oral

Defined daily dose

120 - 150 mg per m² of body surface area (BSA)

Dosage regimen

From 30 To 37.5 mg per m² of body surface area (BSA) 4 time(s) per day every day for 4 day(s)

Detailed description

The conventional dosage plan for conditioning before haemopoietic stem cell transplantation is 30 to 37.5 mg/m² every 6 hours for 4 days, starting seven days prior to transplantation. 60 mg/kg per day of cyclophosphamide is usually given for two days commencing 24 h after the final dose of Busulfan.

Active ingredient

Busulfan

Busulfan is a potent cytotoxic agent and a bifunctional alkylating agent. In aqueous media, release of the methanesulphonate groups produces carbonium ions which can alkylate DNA, thought to be an important biological mechanism for its cytotoxic effect.

Read more about Busulfan

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