Agalsidase beta 5mg powder for solution for infusion vials
Requires a prescription from a doctor or prescriber
Agalsidase beta is a recombinant human α-galactosidase A similar to [agalsidase alfa].
Official documents, adverse reaction reporting, and safety monitoring
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Official medicine documents
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Drug safety updates
MHRA alerts for Agalsidase beta
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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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 beta
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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
MHRA licensed products
View all licensed products for Agalsidase beta on the MHRA register
Fabrazyme 5mg powder for concentrate for solution for infusion vials
WHO defined daily dose (DDD)
5 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: 12 · Randomised trials: 9 · 1983–2026
Showing the 50 most relevant studies, sorted by most relevant.
Banikazemi M, Bultas J, Waldek S, et al.
2007
- Fabry Disease
- Cerebrovascular Disorders
- Kidney Diseases
E. Wallace, O. Goker-Alpan, W. Wilcox, et al.
Journal of Medical Genetics, 2023
- Fabry Disease
- alpha-Galactosidase
- Isoenzymes
A. Ortiz, S. Kanters, A. Hamed, et al.
Clinical Kidney Journal, 2020
P. DasMahapatra, S. Kanters, E. Poggio, et al.
Molecular Genetics and Metabolism, 2019
Lenders M, Brand E
2024
- Fabry Disease
- alpha-Galactosidase
- Isoenzymes
E. Wallace, Wilcox Goker-Alpan, Bernat Holida, et al.
Molecular Genetics and Metabolism, 2023
Moiseev S.V. Moiseev, Shchulkin A.V. Shchulkin, Abalenikhina Yu.V. Abalenikhina, et al.
Nephrology, 2023
Warnock DG, Wallace EL
2024
- Fabry Disease
- alpha-Galactosidase
- Isoenzymes
John Bernat, Eric Wallace, Ozlem Goker-Alpan, et al.
Genetics in Medicine Open, 2023
Ramaswami U, Bichet DG, Clarke LA, et al.
2019
- Skin
- Fabry Disease
- alpha-Galactosidase
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
12 min
Mechanism
α-galactosidase A is uptaken by cells via the mannose 6 phosphate receptor.
Food interactions
None known
Human targets
1 target
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
1 mg/k
Half-life
12 min
[L16383]
Protein binding
[L16383]
Volume of distribution
1 mg/k
[L16383]
Metabolism
[L16383]
…
Elimination
[A182009]
…
Clearance
1 mg/k
[L16383]
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
Agalsidase beta was granted FDA approval on 24 April 2003.[L16383]
[L16383]
Known interactions with other medicines. Always consult a healthcare professional.
Showing 4 of 4 interactions
[L16383]
Patients experiencing an overdose of agalsidase beta may experience an increased incidence and severity of adverse effects.
[L16383]
Overdose can be managed through the use of symptomatic and supportive measures.
How the body processes this drug — absorption, distribution, metabolism, and elimination
[L16383]
[L16383]
[L16383]
[L16383]
[L16383]
However, protein drugs are expected to be degraded by proteases and other catalytic enzymes to smaller peptides and amino acids.
[A182009]
[A182009]
[L16383]
Proteins and enzymes this drug interacts with in the body
Proteins that transport this drug across cell membranes
ATC A16AB04
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 beta
Additional database identifiers
Drugs Product Database (DPD)
13296
Drugs Product Database (DPD)
13300
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