VPRIV POWDER FOR SOLUTION FOR INFUSION 400 UNITS/VIAL [SIN16107P]

Product Info

VPRIV POWDER FOR SOLUTION FOR INFUSION 400 UNITS/VIAL

[SIN16107P]

4.1 Therapeutic indications

VPRIV is indicated for long-term enzyme replacement therapy (ERT) in patients with type 1 Gaucher disease.

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
Renal or hepatic impairment
No dosing adjustment is recommended in patients with renal or hepatic impairment based on current knowledge of the pharmacokinetics and pharmacodynamics of velaglucerase alfa. See section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Paediatric population
Twenty of the 94 patients (21%) who received velaglucerase alfa during clinical studies were in the paediatric and adolescent age range. The studies allowed inclusion of patients 2 years and older; however, no data are available for children under the age of 4 years. The safety and efficacy profiles were similar between paediatric and adult patients. See section 5.1 for further information – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Method of administration
For intravenous infusion use only.
To be administered as a 60-minute intravenous infusion.
Must be administered through a 0.2 micrometre or 0.22 micrometre filter.

Home administration under the supervision of a healthcare professional may be considered only for those patients who have received at least three infusions and were tolerating their infusions well. Appropriate medical support, including adequately trained personnel in emergency measures, should be readily available when velaglucerase alfa is administered. If anaphylactic or other acute reactions occur, immediately discontinue the infusion and initiate appropriate medical treatment. (refer to Section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.3 Contraindications

Severe allergic reaction to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.