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Molecule

Velaglucerase alfa

Hydrolytic Lysosomal Glucocerebroside-specific Enzyme
Available on requestBiologicOrphanCold chainRare diseases and enzyme replacement
Presentations
1
Brands
1
Manufacturers
1
Available from stock
0

Velaglucerase alfa is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy (ERT) for patients with type 1 Gaucher disease. It is available as powder for injection for intravenous use. MedsAcross supplies Velaglucerase alfa for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Hydrolytic Lysosomal Glucocerebroside-specific Enzyme
ATC classification
A16AB10 Velaglucerase alfa · Metabolic disease treatments, including enzyme replacement, subgroup A16A, subgroup A16AB
US FDA first approval
26 February 2010
EU status
Authorised
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Intravenous
Dosage forms
Powder for injection
Biologic
Yes
Identifiers
UNII 23HYE36B0IRxCUI 901805CAS 884604-91-5DrugBank DB06720Q3492447

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

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.

Source: US FDA prescribing information

How it works

Gaucher disease is an autosomal recessive disorder caused by mutations in the GBA gene, which results in a deficiency of the lysosomal enzyme beta-glucocerebrosidase. Glucocerebrosidase catalyzes the conversion of the sphingolipid glucocerebroside into glucose and ceramide. The enzymatic deficiency causes an accumulation of glucocerebroside primarily in the lysosomal compartment of macrophages, giving rise to foam cells or "Gaucher cells". Velaglucerase alfa catalyzes the hydrolysis of glucocerebroside, reducing the amount of accumulated glucocerebroside. In clinical trials VPRIV reduced spleen and liver size, and improved anemia and thrombocytopenia. In this lysosomal storage disorder (LSD), clinical features are reflective of the accumulation of Gaucher cells in the liver, spleen, bone marrow, and other organs.

Source: US FDA prescribing information

Dosing overview

Administration of VPRIV should be supervised by a healthcare provider knowledgeable in the management of hypersensitivity reactions including anaphylaxis. Recommended Starting Dose in Adults and Pediatric Patients 4 Years of Age or Older: Patients Naïve to Enzyme Replacement Therapy: 60 Units/kg. Patients being treated with stable imiglucerase dosages for Gaucher disease: Can switch to VPRIV at previous imiglucerase dose two weeks after last imiglucerase dose. Determine number of vials to be reconstituted based on patient's actual weight and prescribed dose. Supplied VPRIV lyophilized powder must be reconstituted with Sterile Water for Injection. Reconstituted VPRIV solution must be diluted in 100 mL of 0.9% Sodium Chloride Injection prior to intravenous infusion. Administer the diluted VPRIV solution through an in-line low protein-binding 0.2 or 0.22 µm filter

Source: US FDA prescribing information

Warnings and precautions

Boxed warning (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. See boxed warning Hypersensitivity Reactions Including Anaphylaxis Life-threatening hypersensitivity reactions, including anaphylaxis, have occurred in patients treated with enzyme replacement therapies, including VPRIV. VPRIV-treated patients have had these reactions occur in clinical studies and postmarketing experience. Hypersensitivity reactions were the most commonly observed adverse reactions in patients treated with VPRIV in clinical studies. Patients were not routinely pre-medicated prior to infusion of VPRIV during clinical studies.

Source: US FDA prescribing information

Side effects

Most common adverse reactions (≥10%) are: hypersensitivity reactions, headache, dizziness, abdominal pain, nausea, back pain, joint pain, prolonged activated PTT, fatigue/asthenia, and pyrexia.

Source: US FDA prescribing information

Storage

Store VPRIV refrigerated at 2ºC to 8ºC (36ºF to 46ºF) in the original carton to protect from light. Do not freeze.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Velaglucerase alfa, sorted by availability.

MedicineManufacturerRegisterAvailability
Vpriv 2.5 mg/mL powder for injectionIntravenous Cold chainTakeda PharmaceuticalsUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 26 February 2010Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Velaglucerase alfa in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Velaglucerase alfa available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Velaglucerase alfa and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Velaglucerase alfa have?

The catalogue lists 1 brand names for Velaglucerase alfa, including Vpriv.

Is Velaglucerase alfa approved by the US FDA?

Yes. The US FDA first approved Velaglucerase alfa on 26 February 2010, according to Drugs@FDA.

Is Velaglucerase alfa authorised in the European Union?

Yes. Velaglucerase alfa has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Velaglucerase alfa need cold chain shipping?

At least one listed presentation of Velaglucerase alfa must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.

Which ATC class is Velaglucerase alfa in?

Velaglucerase alfa is classified under ATC code A16AB10 (Velaglucerase alfa).

References

  1. VPRIV prescribing information (Takeda Pharmaceuticals). U.S. National Library of Medicine, DailyMed. Retrieved 26 November 2024
  2. Vpriv: European public assessment report (EPAR). European Medicines Agency. Retrieved 25 August 2026

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