Molecule
Pegunigalsidase alfa is a hydrolytic lysosomal neutral glycosphingolipid-specific enzyme indicated for the treatment of adults with confirmed Fabry disease. It is available as injection for intravenous use. MedsAcross supplies Pegunigalsidase 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.
ELFABRIO is indicated for the treatment of adults with confirmed Fabry disease. ELFABRIO is a hydrolytic lysosomal neutral glycosphingolipid-specific enzyme indicated for the treatment of adults with confirmed Fabry disease.
Source: US FDA prescribing information
Fabry disease is caused by deficiency of the lysosomal enzyme alpha-galactosidase A. ELFABRIO provides an exogenous source of alpha-galactosidase A. ELFABRIO is internalized and transported into lysosomes where it is thought to exert enzymatic activity and reduce accumulated globotriaosylceramide (Gb3).
Source: US FDA prescribing information
For pretreatment recommendations, see Full Prescribing Information. Recommended dosage is 1 mg/kg every 2 weeks administered as an intravenous infusion. For dosage and administration modifications due to hypersensitivity reactions or infusion-associated reactions (IARs), see Full Prescribing Information. For instructions on preparation (including dilution), storage, and administration (including rates for the initial 4-6 infusions for ERT-experienced and ERT-naïve patients), see Full Prescribing Information. 2. 1 Recommendations Prior to ELFABRIO Treatment Pretreatment In enzyme replacement therapy (ERT)-experienced patients, if pretreatment with antihistamines, antipyretics, and/or corticosteroids was used prior to ERT administration, consider similar pretreatment with these medications before the first several ELFABRIO infusions.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
Boxed warning (hypersensitivity reactions including anaphylaxis): Patients treated with ELFABRIO have experienced hypersensitivity reactions, including anaphylaxis. Appropriate medical support measures, including cardiopulmonary resuscitation equipment, should be readily available during ELFABRIO administration. Infusion-Associated Reactions: If severe IARs occur, discontinue ELFABRIO and initiate appropriate medical treatment. Membranoproliferative Glomerulonephritis: Monitor serum creatinine and urinary protein to creatinine ratio. Discontinue ELFABRIO if glomerulonephritis is suspected, until a diagnostic evaluation can be conducted.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in labeling: Hypersensitivity Reactions Including Anaphylaxis Infusion-Associated Reactions (IARs) Membranoproliferative Glomerulonephritis Most common adverse reactions (≥15%) are: infusion-associated reactions, nasopharyngitis, headache, diarrhea, fatigue, nausea, back pain, pain in extremity, and sinusitis.
Source: US FDA prescribing information
Store refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Do not shake.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
2 presentations of Pegunigalsidase alfa, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Elfabrio 20 mg/10 mL injectionIntravenous Cold chain | Chiesi | US FDA | Available on request |
| Elfabrio 5 mg/2.5 mL 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 2 presentations of Pegunigalsidase alfa and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Pegunigalsidase alfa, including Elfabrio.
Yes. The US FDA first approved Pegunigalsidase alfa on 9 May 2023, according to Drugs@FDA.
Yes. Pegunigalsidase alfa has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Pegunigalsidase alfa must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Pegunigalsidase alfa is classified under ATC code A16AB20 (Pegunigalsidase alfa).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.