Active Ingredient: Busulfan
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:
Intravenous
3.2 - 3.2 mg per kg of body weight
From 0.8 To 0.8 mg per kg of body weight 4 time(s) per day every day for 4 day(s)
The recommended dose and schedule of administration is:
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).
Patients older than 50 years of age (n=23) have been successfully treated with busulfan without doseadjustment. However, for the safe use of busulfan in patients older than 60 years only limited information is available. Same dose for elderly patients as for adults (<50 years old) should be used.
The recommended dose and schedule of administration is:
The administration of FB regimen has not been specifically investigated in elderly patients. However, more than 500 patients aged ≥55 years were reported in publications with FB conditioning regimens, yielding efficacy outcomes similar to younger patients. No dose adjustment was deemed necessary.
Busulfan should be administered by intravenous infusion via central venous catheter. Busulfan should not be given by rapid intravenous, bolus or peripheral injection.
Oral
4 - 4 mg per kg of body weight
From 1 To 1 mg per kg of body weight 4 time(s) per day every day for 4 day(s)
The recommended dose of busulfan in adult patients is 1 mg/kg every 6 hours for four 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.
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