VPRIV Powder for solution for infusion Ref.[9230] Active ingredients: Velaglucerase alfa

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.

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.

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.

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.

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)

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

There is no experience with overdose of velaglucerase alfa. The maximum dose of velaglucerase alfa in clinical studies was 60 Units/kg. See section 4.4.

Shelf life: 3 years.

Reconstituted and diluted solution for infusion: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C to 8°C under protection from light.

From a microbiological point of view, the medicinal product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and must not exceed 24 hours at 2°C to 8°C.

Store in a refrigerator (2°C-8°C).

Do not freeze.

Keep the vial in the outer carton in order to protect from light.

For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.

20 ml vial (type I glass) with a stopper (fluoro-resin coated butyl rubber), one piece seal, and flip-off cap.

Pack sizes of 1, 5 and 25 vials. Not all pack sizes may be marketed.

VPRIV requires reconstitution and dilution, and is intended for intravenous infusion only. It is for single-use only and is administered through a 0.22 µm filter.

Aseptic technique must be used.

Prepare VPRIV as follows:

1. The number of vials to be reconstituted is determined based on the individual patient’s weight and the prescribed dose.
2. The required vials are removed from the refrigerator. Each 400 Units vial is reconstituted with 4.3 ml of sterile water for injections.
3. Upon reconstitution, vials should be mixed gently. Vials should not be shaken. Each vial will contain an extractable volume of 4.0 ml (100 Units/ml).
4. Prior to further dilution, the solution in the vials should be visually inspected; the solution should be clear to slightly opalescent and colourless; the solution should not be used if it is discoloured or if foreign particulate matter is present.
5. The calculated volume of medicinal product is withdrawn from the appropriate number of vials and the total volume required is diluted in 100 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion. The product should be mixed gently. It should not be shaken. The infusion should be initiated within 24 hours from the time of reconstitution.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.