Prescription medicine
Velaglucerase alfa Brand names: Vpriv
Velaglucerase alfa (Vpriv) is a prescription medicine with an FDA approval on record since 2010. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the velaglucerase alfa FDA label on DailyMed (effective November 26, 2024, Takeda Pharmaceuticals America, Inc.); the BLA 22575 record on Drugs@FDA; every velaglucerase alfa label on DailyMed.
Highlights of the record
FDA label of November 26, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS.
Patients treated with enzyme replacement therapies have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred during the early course of enzyme replacement and after extended duration of therapy. Initiate VPRIV in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue VPRIV and immediately initiate appropriate medical treatment, including use of epinephrine. Inform patients of the symptoms of life-threatening hypersensitivity reactions, including anaphylaxis and to seek immediate medical care should symptoms occur [see Warnings and Precautions (5.1) ]. WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS See full prescribing information for complete boxed warning. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. ( 5.1 ) Initiate VPRIV in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment. […]
Used for
From the label: indications and usageVPRIV is indicated for long-term enzyme replacement therapy (ERT) for patients with type 1 Gaucher disease.
Forms and strengths
- 2.5 mg/ml
Injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- February 26, 2010 Vpriv, Shire Human Genetic; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2014 1 Class I among all firms' recalls; latest March 14, 2014
- FAERS reports
- 2,049 through July 30, 2026
What is velaglucerase alfa used for?
From the label: indications and usageVPRIV 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 pharmacologic class: Hydrolytic Lysosomal Glucocerebroside-specific Enzyme.
Source: FDA drug label (VPRIV), BLA022575 (Shire Human Genetic), as published by Takeda Pharmaceuticals America, Inc., effective November 26, 2024 (SPL set ca02f7a4-ae4f-43c1-a06a-259fe4fcf9cf), via openFDA; the full label on DailyMed
Is there a generic for velaglucerase alfa (Vpriv)?
No generic velaglucerase alfa is approved (Drugs@FDA, October 8, 2026).
- 2010 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has velaglucerase alfa been recalled?
The FDA's Enforcement Report lists 1 recall naming velaglucerase alfa since 2014: 1 Class I (the most serious), 0 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 14, 2014 | Class I | Shire Human Genetic Therapies, Inc. | Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the velaglucerase alfa label say about other medicines?
The velaglucerase alfa label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Epinephrine | boxed warning | … anaphylaxis) occurs, discontinue VPRIV and immediately initiate appropriate medical treatment, including use of epinephrine. |
Source: FDA drug label (VPRIV), BLA022575 (Shire Human Genetic), as published by Takeda Pharmaceuticals America, Inc., effective November 26, 2024 (SPL set ca02f7a4-ae4f-43c1-a06a-259fe4fcf9cf), via openFDA; the full label on DailyMed
What do FAERS reports show for velaglucerase alfa?
The FDA Adverse Event Reporting System holds 2,049 reports that list velaglucerase alfa among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 279 are coded as a death and 879 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other hydrolytic lysosomal glucocerebroside-specific enzymes
- the pharmacologic class, with prices and generics
- Velaglucerase alfa side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other