Busulfan

Busulphan

Therapeutic Indications

Busulfan is indicated for:

Polycythemia vera

Irrespective of gender only Adults (18 - 65 years old)

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Oral - 4-6 mg/kg in 4 divided doses daily

Essential thrombocythaemia

Irrespective of gender only Adults (18 - 65 years old)

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Oral - 2-4 mg/kg in 2-4 divided doses daily

Myelofibrosis

Irrespective of gender only Adults (18 - 65 years old)

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Oral - 2-4 mg/kg in 2-4 divided doses daily

Chronic myeloid leukaemia

Irrespective of gender only Adults (18 - 65 years old)

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Oral - 0.03-0.06 mg/kg once daily

Conditioning treatment prior to conventional haematopoietic progenitor cell transplantation

Irrespective of gender only Adults (18 years old or older)

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, the medical literature mentions below treatments (click for details):

Treatment 1: Intravenous - 3.2 mg/kg in 1-4 divided doses daily

Treatment 2: Oral - 4 mg/kg in 4 divided doses daily

Conditioning treatment prior to conventional haematopoietic progenitor cell transplantation

Irrespective of gender 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, the medical literature mentions below treatments (click for details):

Treatment 1: Intravenous - 3.2-4.8 mg/kg in 4 divided doses daily

Treatment 2: Oral - 120-150 mg/mĀ² in 4 divided doses daily

Contraindications

Active ingredient Busulfan is contraindicated in the following cases:

Pregnancy

No gender/age discrimination

Intravenous infusion

HPCT is contraindicated in pregnant women; therefore, busulfan is contraindicated during pregnancy. Studies in animals have shown reproductive toxicity (embryo-fetal lethality and malformations).

There are no or limited amount of data from the use of busulfan or DMA in pregnant women. A few cases of congenital abnormalities have been reported with low-dose oral busulfan, not necessarily attributable to the active substance, and third trimester exposure may be associated with impaired intrauterine growth.

Oral administration

As with all cytotoxic chemotherapy, adequate contraceptive precautions should be advised when either partner is receiving busulfan.

The use of busulfan should be avoided during pregnancy whenever possible. In animal studies it has the potential for teratogenic effects, whilst exposure during the latter half of pregnancy resulted in impairment of fertility in offspring. In every individual case the expected benefit of treatment to the mother must be weighed against the possible risk to the foetus.

A few cases of congenital abnormalities, not necessarily attributable to busulfan, have been reported and third trimester exposure may be associated with impaired intra-uterine growth. However, there have also been many reported cases of apparently normal children born after exposure to busulfan in utero, even during the first trimester.