- Approval Id
- a3f8241c3365a6ed
- Drug Name
- VPRIV POWDER FOR SOLUTION FOR INFUSION 400 UNITS/VIAL
- Product Name
- VPRIV POWDER FOR SOLUTION FOR INFUSION 400 UNITS/VIAL
- Approval Number
- SIN16107P
- Approval Date
- 2021-02-24
- Registrant
- TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.
- Licence Holder
- TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p>VPRIV treatment should be supervised by a physician experienced in the management of patients with Gaucher disease.</p>
<p><u>Posology</u><br>
The recommended dose is 60 Units/kg administered every other week.</p>
<p>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.</p>
<p>Patients currently treated with imiglucerase enzyme replacement therapy for type 1 Gaucher disease may be switched to VPRIV, using the same dose and frequency.</p>
<p><u>Special populations</u><br>
<em>Renal or hepatic impairment</em><br>
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 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
<p><em>Elderly (≥65 years old)</em><br>
Elderly patients may be treated within the same dose range (15 to 60 units/kg) as other adult patients. See section 5.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
<p><em>Paediatric population</em><br>
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 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
<p><u>Method of administration</u><br>
For intravenous infusion use only.<br>
To be administered as a 60-minute intravenous infusion.<br>
Must be administered through a 0.2 micrometre or 0.22 micrometre filter.</p>
<p>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 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>)</p>
<p>For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>VPRIV is indicated for long-term enzyme replacement therapy (ERT) in patients with type 1 Gaucher disease.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>Severe allergic reaction to the active substance or to any of the excipients listed in section 6.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
- Atc Code
- A16AB10
- Atc Item Name
- velaglucerase alfa
- Pharma Manufacturer Name
- TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.
