Molecule
Avalglucosidase alfa is a hydrolytic lysosomal glycogen-specific enzyme indicated for the treatment of patients 1 year of age and older with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency). MedsAcross supplies Avalglucosidase 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.
NEXVIAZYME is indicated for the treatment of patients 1 year of age and older with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency). NEXVIAZYME is a hydrolytic lysosomal glycogen-specific enzyme indicated for the treatment of patients 1 year of age and older with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency).
Source: US FDA prescribing information
Pompe disease (also known as glycogen storage disease type II, acid maltase deficiency, and glycogenosis type II) is an inherited disorder of glycogen metabolism caused by a deficiency of the lysosomal enzyme acid α-glucosidase (GAA) that degrades glycogen to glucose in the lysosome. GAA deficiency results in intralysosomal accumulation of glycogen in various tissues. Avalglucosidase alfa-ngpt provides an exogenous source of GAA. The M6P on avalglucosidase alfa-ngpt mediates binding to M6P receptors on the cell surface with high affinity. After binding, it is internalized and transported into lysosomes where it undergoes proteolytic cleavage that results in increased GAA enzymatic activity. Avalglucosidase alfa-ngpt then exerts enzymatic activity in cleaving glycogen.
Source: US FDA prescribing information
Consider administering antihistamines, antipyretics, and/or corticosteroids prior to NEXVIAZYME administration to reduce the risk of IARs. NEXVIAZYME is administered as intravenous infusion. For patients weighing: ≥30 kg, the recommended dosage is 20 mg/kg (of actual body weight) every two weeks. <30 kg, the recommended dosage is 40 mg/kg (of actual body weight) every two weeks. See the full prescribing information for dosage modifications due to hypersensitivity reactions or IARs. Must be reconstituted and diluted prior to use. For instructions on storage and administration, see full prescribing information.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
Boxed warning: Hypersensitivity Reactions Including Anaphylaxis Appropriate medical monitoring and support measures, including cardiopulmonary resuscitation equipment, should be readily available. If a severe hypersensitivity reaction occurs, discontinue NEXVIAZYME immediately and initiate appropriate medical treatment. See boxed warning. Hypersensitivity Reactions Including Anaphylaxis Life-threatening hypersensitivity reactions, including anaphylaxis, have been reported in NEXVIAZYME-treated patients. In NEXVIAZYME clinical studies, 67 (48%) NEXVIAZYME-treated patients experienced hypersensitivity reactions, including 6 (4%) patients who reported severe hypersensitivity reactions and 3 (2%) patients who experienced anaphylaxis, 2 (1%) patients who experienced anaphylaxis discontinued from the study. Some of the hypersensitivity reactions were IgE mediated.
Source: US FDA prescribing information
The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Hypersensitivity Reactions Including Anaphylaxis Infusion-Associated Reactions (IARs) The most common adverse reactions (>5%) were headache, fatigue, diarrhea, nausea, arthralgia, dizziness, myalgia, pruritus, vomiting, dyspnea, erythema, paresthesia and urticaria.
Source: US FDA prescribing information
Store refrigerated at 2°C to 8°C (36°F to 46°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Avalglucosidase alfa, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Nexviazyme 100 mg/10 mL powder for injectionIntravenous Cold chain | Genzyme | 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 Avalglucosidase alfa and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Avalglucosidase alfa, including Nexviazyme.
Yes. The US FDA first approved Avalglucosidase alfa on 6 August 2021, according to Drugs@FDA.
Yes. Avalglucosidase alfa has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Avalglucosidase alfa must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Avalglucosidase alfa is classified under ATC code A16 (Metabolic disease treatments, including enzyme replacement).
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