Posology : מינונים

4.2   Posology and method of administration

VPRIV treatment should be supervised by a physician experienced in the management of patients with Gaucher disease.

Posology

The recommended dose is 60 Units/kg administered every other week.
Dose adjustments can be made on an individual basis based on achievement and maintenance of therapeutic goals. Clinical studies have evaluated doses ranging from 15 to 60 Units/kg every other week. Doses higher than 60 Units/kg have not been studied.

Patients currently treated with imiglucerase enzyme replacement therapy for type 1 Gaucher disease may be switched to VPRIV, using the same dose and frequency.

Special populations


1
Elderly (≥65 years old)
Elderly patients may be treated within the same dose range (15 to 60 Units/kg) as other adult patients (see section 5.1).

Renal impairment
No dosing adjustment is recommended in patients with renal impairment based on current knowledge of the pharmacokinetics and pharmacodynamics of velaglucerase alfa (see section 5.2).

Hepatic impairment
No dosing adjustment is recommended in patients with hepatic impairment based on current knowledge of the pharmacokinetics and pharmacodynamics of velaglucerase alfa (see section 5.2).

Paediatric population
Twenty of the 94 patients (21%) who received velaglucerase alfa during clinical studies were in the paediatric and adolescent age range (4 to 17 years). The safety and efficacy profiles were similar between paediatric and adult patients (see section 5.1 for further information).

The safety and efficacy of velaglucerase alfa in children below the age of 4 years have not yet been established. No data are available.

Method of administration

For intravenous infusion use only.
To be administered as a 60-minute intravenous infusion.
Must be administered through a 0.22 µm filter.
For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.