Agalsidase alfa 1mg/1ml solution for infusion vials
Agalsidase alfa is a recombinant human α-galactosidase A similar to [agalsidase beta].
Official documents, adverse reaction reporting, and safety monitoring
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Official medicine documents
Yellow Card
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Drug safety updates
MHRA alerts for Agalsidase alfa
Safety monitoring data
Yellow Card reports
The MHRA Yellow Card scheme collects reports of suspected side effects from healthcare professionals and patients. View the Drug Analysis Profile (iDAP) for real-world adverse reaction data.
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Report a side effect
Submit a Yellow Card report to the MHRA
Data from the MHRA Yellow Card scheme. A reported reaction does not necessarily mean the medicine caused it. Contains public sector information licensed under the Open Government Licence v3.0.
EudraVigilance
The European Medicines Agency (EMA) collects suspected adverse reaction reports from across the EU/EEA through the EudraVigilance system. Search for safety data on this medicine.
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Suspected adverse reactions reported for Agalsidase alfa
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Learn about EU pharmacovigilance and safety monitoring
EudraVigilance data is published by the European Medicines Agency (EMA). A suspected adverse reaction is not necessarily caused by the medicine.
1 branded products available
WHO defined daily dose (DDD)
1 mg
Not a recommended dose. The DDD is the assumed average maintenance dose per day for a drug used for its main indication in adults. It is a statistical measure used for research and comparison purposes only.
Source: WHO Collaborating Centre for Drug Statistics Methodology, distributed via the NHS dm+d supplementary mapping files (NHSBSA). Contains public sector information licensed under the Open Government Licence v3.0.
Therapeutically similar medicines
Similarity is based on WHO Anatomical Therapeutic Chemical (ATC) classification and on a factual NHS dm+d therapeutic-grouping code prefix. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
NHS prescribing volume and spending trends
Guidelines from the National Institute for Health and Care Excellence
NICE clinical guidance(2)
Pegunigalsidase alfa for treating Fabry disease (TA915)
Migalastat for treating Fabry disease (HST4)
Source: National Institute for Health and Care Excellence (NICE). Contains public sector information licensed under the Open Government Licence v3.0.
Check stock at pharmacies and supply information
Pharmacy stock checkers
Search for this medicine at major UK pharmacy chains. These links open the retailer's own website — results depend on their current online catalogue.
Supply & safety information
Official UK regulator monitoring and safety alerts
Pharmacy links redirect to the retailer's own search and do not represent real-time stock levels. Shortage and safety information sourced from MHRA drug safety updates (gov.uk, Crown Copyright under OGL v3.0).
Codes for healthcare professionals and prescribing systems
These codes are used by healthcare IT systems and prescribers to identify this medicine.
NHS UK identifiers
Browse tools
SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Academic studies and reviews for this medicine's active substance
Showing the 50 most relevant studies.
Reviews & meta-analyses: 19 · Randomised trials: 14 · 1994–2025
Showing the 50 most relevant studies, sorted by most relevant.
JNCI Journal of the National Cancer Institute, 1997
D. Hughes, P. Elliott, J. Shah, et al.
Heart, 2007
A. Vedder, G. Linthorst, G. Houge, et al.
PLoS ONE, 2007
- Cerebral Ventricles
- Fabry Disease
- alpha-Galactosidase
Michael P Manns, John G McHutchison, Stuart C Gordon, et al.
The Lancet, 2001
GHJ Mickisch, A Garin, H van Poppel, et al.
The Lancet, 2001
Lise L Kjaergard, Kim Krogsgaard, Christian Gluud
BMJ, 2001
E. Wallace, O. Goker-Alpan, W. Wilcox, et al.
Journal of Medical Genetics, 2023
- Fabry Disease
- alpha-Galactosidase
- Isoenzymes
SB Ainsworth, MW Beresford, DWA Milligan, et al.
The Lancet, 2000
Lenders M, Brand E
2024
- Fabry Disease
- alpha-Galactosidase
- Isoenzymes
E. Wallace, Wilcox Goker-Alpan, Bernat Holida, et al.
Molecular Genetics and Metabolism, 2023
Sources: aggregated from Europe PMC (EMBL-EBI), OpenAlex, Crossref, PubMed and other open scholarly databases. Retracted articles are excluded. Study information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
None known
Half-life
17 minutes
Mechanism
α-galactosidase A is uptaken by cells via the mannose 6 phosphate receptor.
Food interactions
None known
Human targets
2 targets
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
499 min
[A220338]
…
Half-life
17 minutes
[L16398]
Protein binding
[L16398]
Volume of distribution
17%
[A220338][L16398]
…
Metabolism
[L16398]
…
Elimination
[A182009]
…
Clearance
0.007-0.2 mg/k
[L16398]
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
Agalsidase alfa was granted EMA approval on 3 August 2001.[L16413]
[L16398]
Known interactions with other medicines. Always consult a healthcare professional.
Showing 6 of 6 interactions
[L16398]
Patients experiencing an overdose of agalsidase alfa may experience an increased incidence and severity of adverse effects. Overdose can be managed through the use of symptomatic and supportive measures.
How the body processes this drug — absorption, distribution, metabolism, and elimination
[A220338]
[L16398]
[L16398]
[A220338][L16398]
[L16398]
However, protein drugs are expected to be degraded by proteases and other catalytic enzymes to smaller peptides and amino acids.
[A182009]
[A182009]
[L16398]
Proteins and enzymes this drug interacts with in the body
Proteins that transport this drug across cell membranes
ATC A16AB03
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Show
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Agalsidase alfa
Additional database identifiers
Drugs Product Database (DPD)
13300
HUGO Gene Nomenclature Committee (HGNC)
HGNC:4296
GenAtlas
GLA
GeneCards
GLA
GenBank Gene Database
X05790
UniProt Accession
AGAL_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:6752
GeneCards
M6PR
UniProt Accession
MPRD_HUMAN
DrugBank citations
If you use DrugBank data in your research, please cite:
- DrugBank 6.02024Recommended citationKnox C., Wilson M., Klinger C.M., et alDrugBank 6.0: the DrugBank Knowledgebase for 2024Nucleic Acids Res. 2024 Jan 552(D1):D1265-D1275
- DrugBank 5.02018Wishart D.S., Feunang Y.D., Guo A.C., et alDrugBank 5.0: a major update to the DrugBank database for 2018Nucleic Acids Res. 2017 Nov 846(D1):D1074-D1082
- DrugBank 4.02014Law V., Knox C., Djoumbou Y., et alDrugBank 4.0: shedding new light on drug metabolismNucleic Acids Res. 2014 Jan 142(1):D1091-7
- DrugBank 3.02011Knox C., Law V., Jewison T., et alDrugBank 3.0: a comprehensive resource for 'omics' research on drugsNucleic Acids Res. 2011 Jan39(Database issue):D1035-41
- DrugBank 2.02008Wishart D.S., Knox C., Guo A.C., et alDrugBank: a knowledgebase for drugs, drug actions and drug targets.Nucleic Acids Research2008 Jan36(Database issue):D901-6
- DrugBank 1.02006Wishart D.S., Knox C., Guo A.C., et alDrugBank: a comprehensive resource for in silico drug discovery and exploration.Nucleic Acids Research2006 Jan 134(Database issue):D668-72