Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Elosulfase alfa
Drug ID BADD_D00758
Description Elosulfase alfa is a synthetic version of the enzyme N-acetylgalactosamine-6-sulfatase. It was approved by the FDA in 2014 for the treatment of Morquio syndrome. Elosulfase alfa was developed by BioMarin Pharmaceutical Inc. and is marketed under the brand Vimizim™. The recommended dose is 2 mg per kg given intravenously over a minimum range of 3.5 to 4.5 hours, based on infusion volume, once every week.
Indications and Usage Vimizim is a hydrolytic lysosomal glycosaminoglycan (GAG)-specific enzyme indicated for patients with Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome).
Marketing Status approved; investigational
ATC Code A16AB12
DrugBank ID DB09051
KEGG ID D10333
MeSH ID C102295
PubChem ID Not Available
TTD Drug ID D0J1UA
NDC Product Code 68135-100; 71931-500
UNII ODJ69JZG85
Synonyms GALNS protein, human | N-acetylgalactosamine-6-sulfatase, human | mucopolysaccharidosis type IVA protein, human | galactose-6-sulfate sulfatase, human | GALNAC6S protein, human | Morquio syndrome protein, human | galactosamine (N-acetyl)-6-sulfate sulfatase, human | Vimizim | elosulfase alfa | BMN-100 | BMN 110
Chemical Information
Molecular Formula Not Available
CAS Registry Number 9025-60-9
SMILES Not Available
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal pain07.01.05.002--
Anaphylactic reaction10.01.07.001; 24.06.03.006--
Chills08.01.09.001; 15.05.03.016--
Fatigue08.01.01.002--
Headache17.14.01.001--
Hypersensitivity10.01.03.003--
Nausea07.01.07.001--
Pyrexia08.05.02.003--
Vomiting07.01.07.003--
Immunology test13.06.03.007---
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