Table of Contents
1. Name of the medicinal product
2. Qualitative and quantitative composition
3. Pharmaceutical form
4. Clinical particulars
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Fertility, pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. Pharmacological properties
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. Pharmaceutical particulars
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. Marketing authorisation holder
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
10. Date of revision of the text
1. Name of the medicinal product
 Busilvex 6 mg/ml concentrate for solution for infusion
2. Qualitative and quantitative composition
 One ml of concentrate contains 6 mg of busulfan (60 mg in 10 ml).
After dilution: 1 ml of solution contains 0.5 mg of busulfan
For the full list of excipients see section 6.1
3. Pharmaceutical form
 Concentrate for solution for infusion (sterile concentrate).
Clear, colourless solution.
Go to top of the page4. Clinical particulars
4.1 Therapeutic indications
 Busilvex 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.
Busilvex followed by cyclophosphamide (BuCy4) or melphalan (BuMel) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in paediatric patients.
2 Posology and method of administration
 Busilvex administration should be supervised by a physician experienced in conditioning treatment prior to haematopoietic progenitor cell transplantation.
Busilvex is administered prior to the conventional haematopoietic progenitor cell transplantation (HPCT).
Posology in adults
The recommended dose and schedule of administration is:
- 0.8 mg/kg body weight (BW) of busulfan as a two-hour infusion every 6 hours over 4 consecutive days for a total of 16 doses,
- followed by cyclophosphamide at 60 mg/kg/day over 2 days initiated for at least 24 hours following the 16th dose of Busilvex (see section 4.5).
Posology in paediatric population (0 to 17 years)
The recommended dose of Busilvex is as follows: