or injection or glucose (5%) solution for injection.
The residual medicinal product must be flushed in the administration tubing as rapid infusion of Busilvex has not been tested and is not recommended.
The entire prescribed Busilvex dose should be delivered over two hours.
Small volumes may be administered over 2 hours using electric syringes. In that case infusion sets with minimal priming space should be used (i.e 0.3-0.6 ml), primed with medicinal product solution prior to beginning the actual Busilvex infusion and then flushed with sodium chloride 9 mg/ml (0.9%) solution for injection or glucose (5%) solution for injection.
Busilvex must not be infused concomitantly with another intravenous solution.
Polycarbonate syringes must not be used with Busilvex.
For single use only. Only a clear solution without particles should be used.
PROCEDURE FOR PROPER DISPOSAL
Any unused product or waste should be disposed of in accordance with local requirements for cytotoxic medicinal products.
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For doctors
What is it?
Busilvex is a concentrate to be made up into a solution for infusion (drip into a vein). It contains the active substance busulfan.
What is it used for?
Busilvex is used in adults and children as a ‘conditioning’ (preparative) treatment before transplantation of haematopoietic progenitor cells (the cells that make blood cells). This type of transplant is used in patients who need to replace their blood-making cells, because they have a blood disorder (such as a rare type of anaemia) or a cancer of the blood. Busilvex treatment is followed by treatment with another medicine (cyclophosphamide in adults, and cyclophosphamide or melphalan in children).
Because of the number of patients in the European Union (EU) that undergo this type of conditioning and transplant is low, busulfan was designated as an ‘orphan medicine’ (a medicine used in rare diseases) on 29 December 2000.
The medicine can only be obtained with a prescription.
How is it used?
Busilvex should be used by a doctor who has experience in treatments given before transplantation. The recommended dose of Busilvex in adults is 0.8 mg per kilogram body weight. In children up to 17 years of age, the recommended dose of Busilvex is based on the weight of the child and varies between 0.8 and 1.2 mg/kg. Busilvex is given as a central intravenous infusion (drip into a central vein in the chest). Each infusion lasts for two hours and it is given to the patient every six hours on four consecutive days before treatment with cyclophosphamide or melphalan and the transplant. Before receiving Busilvex, patients are given anticonvulsive medicines (to prevent seizures) and anti-emetic medicines (to prevent vomiting).
How does it work?
The active substance in Busilvex, busulfan, belongs to a group of medicines called ‘alkylating agents’. These substances are ‘cytotoxic’. This means that they kill cells, especially cells that develop rapidly, such as cancer or progenitor (or ‘stem’) cells (cells that make other types of cell). Busulfan is used before transplantation to destroy abnormal cells and the patient’s existing haematopoietic progenitor c
