Molecule
Velmanase alfa is a prescription medicine indicated for the treatment of non-central nervous system manifestations of alpha-mannosidosis in adult and pediatric patients. It is available as powder for injection for intravenous use. MedsAcross supplies Velmanase 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
From the regulator-approved product information. Each section names its source.
1 INDICA TIONS AND USAGE LAMZEDE is indicated for the treatment of non-central nervous system manifestations of alpha-mannosidosis in adult and pediatric patients. LAMZEDE is recombinant human lysosomal alpha-mannosidase indicated for the treatment of non-central nervous system manifestations of alpha-mannosidosis in adult and pediatric patients.
Source: US FDA prescribing information
Alpha-mannosidosis is a lysosomal storage disease that results from reduced activity of the enzyme alpha-mannosidase, caused by gene variants in Mannosidase Alpha Class 2B Member 1. Alpha-mannosidase catalyzes the degradation of accumulated mannose-containing oligosaccharides. The deficiency of alpha-mannosidase causes an intra-lysosomal accumulation of mannose-rich oligosaccharides in various tissues. Velmanase alfa-tycv provides an exogenous source of alpha-mannosidase. Velmanase alfa-tycv is internalized via binding to the mannose-6-phosphate receptor on the cell surface and transported into lysosomes where it is thought to exert enzyme activity.
Source: US FDA prescribing information
For females of reproductive potential, verify that the patient is not pregnant prior to initiating treatment. Consider pretreating with antihistamines, antipyretics, and/or corticosteroids prior to LAMZEDE administration. Recommended LAMZEDE dosage is 1 mg/kg (actual body weight) administered once every week as an intravenous infusion. See the full prescribing information for dosage modifications due to hypersensitivity reactions or IARs. See the full prescribing information for reconstitution and administration instructions.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
Boxed warning (severe hypersensitivity reactions): Hypersensitivity Reactions Including Anaphylaxis Patients treated with LAMZEDE have experienced hypersensitivity reactions, including anaphylaxis. Appropriate medical support measures, including cardiopulmonary resuscitation equipment, should be readily available during LAMZEDE administration. Infusion -Associ ated Reactions (IARs): If severe IARs occur, discontinue LAMZEDE and initiate appropriate medical treatment. Embryo - F etal Toxicity: May cause fetal harm. Advise females of reproductive potential to use effective contraception during treatment and for 14 days after the last dose if LAMZEDE is discontinued.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions Including Anaphylaxis Infusion-Associated Reactions (IARs) Most common adverse reactions (incidence > 20%) are hypersensitivity reactions including anaphylaxis, nasopharyngitis, pyrexia, headache, and arthralgia.
Source: US FDA prescribing information
Store refrigerated at 2°C to 8°C (36°F to 46°F) 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.
1 presentations of Velmanase alfa, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Lamzede 10 mg powder for injectionIntravenous Cold chain | Chiesi | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 1 presentations of Velmanase alfa and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Velmanase alfa, including Lamzede.
Yes. The US FDA first approved Velmanase alfa on 16 February 2023, according to Drugs@FDA.
Yes. Velmanase alfa has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Velmanase alfa must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Velmanase alfa is classified under ATC code A16AB15 (Velmanase alfa).
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