Busulfex Caution For Usage

Special precautions for disposal and other handling: Preparation of Busulfex: Procedures for proper handling and disposal of anticancer medicinal products should be considered. All transfer procedures require strict adherence to aseptic techniques, preferably employing a vertical laminar flow safety hood. As with other cytotoxic compounds, caution should be exercised in handling and preparing the Busulfex solution: The use of gloves and protective clothing is recommended; If Busulfex or diluted Busulfex solution contacts the skin or mucosa, wash them thoroughly with water immediately.
Calculation of the quantity of Busulfex to be diluted and of the diluent: Busulfex must be diluted prior to use with either 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP.
The quantity of the diluent must be 10 times the volume of Busulfex ensuring the final concentration of busulfan remains at approximately 0.5 mg/ml. By example: The amount of Busulfex and diluent to be administered would be calculated as follows: for a patient with a Y kg body weight: Quantity of Busulfex: See Equation 3.

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Y: body weight of the patient in kg.
D: dose of Busulfex (see Dosage & Administration).
Quantity of diluent: See Equation 4.

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To prepare the final solution for infusion, add (A) ml of Busulfex to (B) ml of diluent (0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP).
Preparation of the solution for infusion: Busulfex must be prepared by a healthcare professional using sterile transfer techniques.
Using a non polycarbonate syringe fitted with a needle: the calculated volume of Busulfex must be removed from the vial; the contents of the syringe must be dispensed into an intravenous bag (or syringe) which already contains the calculated amount of the selected diluent. Busulfex must always be added to the diluent, not the diluent to Busulfex. Busulfex must not be put into an intravenous bag that does not contain 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP.
The diluted solution must be mixed thoroughly by inverting several times.
After dilution, 1 ml of solution for infusion contains 0.5 mg of busulfan.
Diluted Busulfex is a clear colourless solution.
Instructions for use: Prior to and following each infusion, flush the indwelling catheter line with approximately 5 ml of 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP.The residual medicinal product must not be flushed in the administration tubing as rapid infusion of Busulfex has not been tested and is not recommended. The entire prescribed Busulfex dose should be delivered over two or three hours depending of the conditioning regimen.
Small volumes may be administered over 2 hours using electric syringes. In this 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 Busulfex infusion and then flushed with 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP.
Busulfex must not be infused concomitantly with another intravenous solution.
Due to incompatibility, do not use any infusion components containing polycarbonate with Busulfex.
For single use only. Only a clear solution without any particles should be used.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements for cytotoxic medicinal products.
Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned previously.
Due to incompatibility, do not use any infusion components containing polycarbonate with Busulfex.