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FDA Labeling Changes

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


There is currently no drug history available for this drug.

Other Information

The active ingredient of VPRIV is velaglucerase alfa, which is produced by gene activation technology in a human fibroblast cell line. Velaglucerase alfa is a glycoprotein of 497 amino acids; with a molecular weight of approximately 63 kDa. Velaglucerase alfa has the same amino acid sequence as the naturally occurring human enzyme, glucocerebrosidase. Velaglucerase alfa contains 5 potential N-linked glycosylation sites; four of these sites are occupied by glycan chains. Velaglucerase alfa contains predominantly high mannose-type N-linked glycan chains. The high mannose type N-linked glycan chains are specifically recognized and internalized via the mannose receptor present on the surface on macrophages, the cells that accumulate glucocerebroside in Gaucher disease. Velaglucerase alfa catalyzes the hydrolysis of the glycolipid glucocerebroside to glucose and ceramide in the lysosome.

VPRIV is a hydrolytic lysosomal glucocerebroside-specific enzyme. VPRIV is dosed by Units/kg, where one Unit of enzyme activity is defined as the quantity of enzyme required to convert one micromole of p-nitrophenyl ß-D-glucopyranoside to p-nitrophenol per minute at 37°C.

VPRIV is supplied as a sterile, preservative free, lyophilized powder in single-use vials, each containing 400 Units, for intravenous use. Following reconstitution with Sterile Water for Injection, USP, the solution contains the components listed in Table 2.

Table 2: Composition of VPRIV Reconstituted Solution
Extractable 400 Units/vial
Active Ingredient
velaglucerase alfa400 Units
Inactive Ingredients
citric acid, monohydrate5.04 mg
polysorbate 200.44 mg
sodium citrate, dihydrate51.76 mg
Sucrose200 mg

Vpriv Manufacturers

  • Shire Us Manufacturing Inc.
    Vpriv (Velaglucerase Alfa) Injection, Powder, Lyophilized, For Solution [Shire Us Manufacturing Inc.]

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