Quick answers
- What is Velaglucerase alfa used for?
- The FDA-approved label (Vpriv, Takeda Pharmaceuticals America, Inc., November 26, 2024) says: “VPRIV is indicated for long-term enzyme replacement therapy (ERT) for patients with type 1 Gaucher disease. VPRIV is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy (ERT) for patients with type 1 Gaucher disease.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Velaglucerase alfa have a boxed warning?
- Yes. The FDA label for Vpriv has a boxed warning (“WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Velaglucerase alfa?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Velaglucerase alfa been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started March 14, 2014 (Class I). A recall usually concerns specific lots, not every product.
- Who makes Velaglucerase alfa?
- 1 company lists prescription products of Velaglucerase alfa in the FDA NDC Directory, including Takeda Pharmaceuticals America, Inc..
What Velaglucerase alfa is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
VPRIV is indicated for long-term enzyme replacement therapy (ERT) for patients with type 1 Gaucher disease. VPRIV is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy (ERT) for patients with type 1 Gaucher disease.
— FDA label: Vpriv, Takeda Pharmaceuticals America, Inc., effective November 26, 2024. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS
. Read it on the full label →
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Vpriv |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Takeda Pharmaceuticals America, Inc.1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA022575 VPRIV | Shire Human Genetic | February 26, 2010 | 16, latest July 10, 2024 2024: Labeling · 2020: Labeling · 2019: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
March 14, 2014 · Class I · Terminated · D-1251-2014
Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate.
VPRIV¿ (velaglucerase alfa for injection) , Lyophilized Powder, 400 Units/vial, Rx Only. Shire Human Genetic Therapies, Inc. 300 Shire Way, Lexington, MA 02421. NDC: 54092-701-04. — Shire Human Genetic Therapies, Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 901808, 901812 |
|---|---|
| SPL set ID of the quoted label | ca02f7a4-ae4f-43c1-a06a-259fe4fcf9cf |
| FDA labels (SPL) | 1 |
| FDA applications | BLA022575 |
| Active ingredients (FDA) | VELAGLUCERASE ALFA |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Vpriv, Takeda Pharmaceuticals America, Inc., effective November 26, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →