Laronidase 500units/5ml solution for infusion vials
Requires a prescription from a doctor or prescriber
Human recombinant alpha-L-iduronidase, 628 residues (mature form), produced by recombinant DNAtechnology in a Chinese hamster ovary cell line.
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Safety monitoring data
Yellow Card reports
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Suspected adverse reactions reported for Laronidase
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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
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Suspected adverse reactions reported for Laronidase
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1 branded products available
MHRA licensed products
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Aldurazyme 500units/5ml concentrate for solution for infusion vials
WHO defined daily dose (DDD)
1000 unit
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 BNF/ATC 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
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Supply & safety information
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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
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SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. BNF code shown is the factual mapping value distributed by NHS Business Services Authority (NHSBSA) in the dm+d supplementary file under OGL v3.0; it is not affiliated with, nor licensed from, the publishers of the British National Formulary. 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: 10 · 2004–2026
Showing the 50 most relevant studies, sorted by most relevant.
Alícia Dorneles Dornelles, Osvaldo Artigalás, André Anjos da Silva, et al.
PLoS ONE, 2017
- Clinical Trials as Topic
- Iduronidase
- Mucopolysaccharidosis I
OBJECTIVE: To evaluate the efficacy and safety of IV laronidase for MPS I. METHODS: A systematic literature review was performed by searching the ClinicalTrials.gov, MEDLINE/PubMed, EMBASE, LILACS, and Cochrane Library databases, limited to clinical trials published until December 31, 2016. The first inclusion criterion was being a randomized controlled trial (RCT). If < five RCTs were identified, open-label and nonrandomized trials, controlled or uncontrolled (quasi-experimental), including ≥ five patients, and evaluating relevant outcomes defined a priori, would also be included. For meta-analysis, primary inferences were based on random-effects models. Assessment of article quality was performed in accordance with the GRADE criteria. The Cochrane Risk of Bias tool was used to examine the risk of bias for RCTs. RESULTS: The selection phase retrieved 632 articles. During the first phase of selection, 158 had the abstract or full text read for assessment of eligibility, of which nine (two RCTs) were included for qualitative synthesis. Four papers were included in the meta-analysis, which was performed for the following outcomes: occurrence of treatment-emergent or infusion-related adverse events (65%; 95%CI 53, 76), mild in most cases; development of IgG antibodies to laronidase (88%; 95%CI 67, 100); apnea-hypopnea index (not significant-NS), urinary glycosaminoglycans (GAGs) [mean change -65.5 μg/mg creatinine (95%CI -68.8, -62.3)], liver size [mean change -31.03% (95%CI -36.1, -25.9)], left ventricular mass index (LVMI) [mean change -1.8 (95%CI -2.32, -0.25)], and distance covered in the 6-minute walk test (NS). Among the outcomes not included in meta-analysis, we found evidence for benefit of laronidase only on shoulder flexion. CONCLUSIONS: Our findings suggest that IV laronidase effectively reduces urinary GAGs excretion, hepatomegaly and LVMI, and can improve shoulder flexion in MPS I patients. Laronidase appears to be safe in the studied population.
Abstract licence: CC BY 4.0
Jordi Pérez‐López, Montserrat Morales‐Conejo, M. López Rodríguez, et al.
Molecular Genetics and Metabolism, 2017
- Enzyme Replacement Therapy
- Clinical Studies as Topic
- Age Factors
Yong Xue, S. Richards, Asif Mahmood, et al.
Molecular genetics and metabolism, 2016
- Antibodies
- Clinical Trials as Topic
- Drug Hypersensitivity
J. Wraith
Expert Opinion on Pharmacotherapy, 2005
- Clinical Trials as Topic
- Glycosaminoglycans
- Iduronidase
J. E. Wraith, L. Clarke, Michael Beck, et al.
The Journal of Pediatrics, 2004
- Analysis of Variance
- Iduronidase
- Mucopolysaccharidosis I
L. Clarke, J. E. Wraith, Michael Beck, et al.
PEDIATRICS, 2008
- Exanthema
- Headache
- Iduronidase
J. E. Wraith, Michael Beck, Roderick Lane, et al.
PEDIATRICS, 2007
- Child Development
- Glycosaminoglycans
- Iduronidase
Monica Sifuentes, Robin Winkler Doroshow, Richard H. Hoft, et al.
Molecular Genetics and Metabolism, 2006
- Body Height
- Body Weight
- Central Nervous System Diseases
Elisabeth Jameson, Simon Jones, Tracey Remmington
Cochrane Database of Systematic Reviews, 2016
- Antibodies
- Iduronidase
- Mucopolysaccharidosis I
E. Jameson, Simon A. Jones, J. E. Wraith
The Cochrane database of systematic reviews, 2013
- Iduronidase
- Mucopolysaccharidosis I
- Rare Diseases
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
1.5-3.6 hrs
Mechanism
Laronidase catalyses the hydrolysis of terminal alpha-L-iduronic acid residues of dermatan sulfate and heparin sulfate.
Food interactions
None known
Human targets
1 target
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Half-life
1.5-3.6 hrs
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
How the body processes this drug — absorption, distribution, metabolism, and elimination
ATC A16AB05
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
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Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Laronidase
DrugBank citations
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Structured knowledge from the free knowledge base
ATC classifications (Wikidata)
Linked open data from Wikidata (Q20801774), a free and open knowledge base operated by the Wikimedia Foundation. Data is available under the Creative Commons CC0 1.0 Public Domain Dedication.