Posology : מינונים

4.2     Posology and method of administration

Defitelio® must be prescribed and administered to patients by specialised physicians experienced in the diagnosis and treatment of complications of HSCT.

Posology

The recommended dose is 6.25 mg/kg body weight every 6 hours (25 mg/kg/day).
There is limited efficacy and safety data on doses above this level and consequently it is not recommended to increase the dose above 25 mg/kg/day.

The treatment should be administered for a minimum of 21 days and continued until the symptoms and signs of severe VOD resolve.

Renal impairment

Dose adjustment is not required for patients with renal impairment or who are on intermittent haemodialysis (see section 5.2).


Hepatic impairment

No formal pharmacokinetic studies have been performed in patients with hepatic impairment; however, the medicinal product has been used in clinical studies of patients developing hepatic impairment without dose adjustment with no safety issues identified. No dose adjustment is therefore recommended but careful monitoring of patients should be undertaken (see section 5.2).

Paediatric population

The recommended dose for children aged 1 month to 18 years is the same mg/kg dose as for adults i.e.
6.25 mg/kg body weight every 6 hours.
The safety and efficacy of defibrotide in children aged less than 1 month has not yet been established.
No data are available. The use of Defitelio® in children aged less than one month is not recommended.

Method of administration

Defitelio® is for intravenous use. It is administered by intravenous infusion, over two hours.
Defitelio® should always be diluted prior to use. It can be diluted with 5% glucose solution for infusion or sodium chloride 9 mg/mL (0.9%) solution for infusion, to a suitable concentration to permit infusion over 2 hours. The total volume of infusion should be determined based on the individual’s patient weight. The final concentration of Defitelio® should be in the range of 4 mg/mL to 20 mg/mL.

Vials are intended for a single use and unused solution from a single dose must be discarded (see section 6.6)

For instructions on dilution of the medicinal product before administration, see section 6.6.