elosulfase alfa 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
enzymes 4999 9025-60-9

Description:

MoleculeDescription

Synonyms:

  • elosulfase alfa
  • vimizim
  • BMN 110
  • rhGALNS
  • EC 3.1.6.4
  • BMN-110
BMN-100 and BMN 110 are recombinant GALNS; RefSeq NM_000512
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
20 mg P

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
Feb. 14, 2014 FDA BIOMARIN PHARM
April 28, 2014 EMA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Pyrexia 70.31 40.75 57 914 660428 89967048
Knee deformity 66.99 40.75 12 959 1550 90625926
Vascular access complication 43.74 40.75 9 962 2404 90625072
Developmental hip dysplasia 41.29 40.75 8 963 1577 90625899

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Knee deformity 58.37 55.29 10 583 769 42619973
Spinal cord compression 57.39 55.29 13 580 4211 42616531

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Pyrexia 89.62 43.36 77 1198 898188 109689836
Knee deformity 79.27 43.36 14 1261 1549 110586475
Spinal cord compression 78.18 43.36 18 1257 7534 110580490
Developmental hip dysplasia 46.72 43.36 7 1268 276 110587748
Urticaria 45.67 43.36 34 1241 318823 110269201
Oxygen saturation decreased 45.33 43.36 26 1249 156956 110431068
Cough 44.45 43.36 39 1236 461602 110126422

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A16AB12 ALIMENTARY TRACT AND METABOLISM
OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
Enzymes
FDA CS M0000794 alpha-Glucosidases
FDA EPC N0000175823 Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme

Related Drugs by ATC class:

A16AB Enzymes 24 drugs

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Mucopolysaccharidosis, MPS-IV-A indication 7259005 DOID:0111391




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

IDSource
D10333 KEGG_DRUG
4033117 VUID
N0000190127 NUI
4033117 VANDF
CHEBI:753624 CHEBI
CHEMBL2108676 ChEMBL_ID
C102295 MESH_SUPPLEMENTAL_RECORD_UI
7392 IUPHAR_LIGAND_ID
DB09051 DRUGBANK_ID
1489914 RXNORM
213108 MMSL
30194 MMSL
d08244 MMSL
015387 NDDF
702395005 SNOMEDCT_US
716640004 SNOMEDCT_US
C3817397 UMLSCUI
9686 INN_ID
ODJ69JZG85 UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
VIMIZIM HUMAN PRESCRIPTION DRUG LABEL 1 68135-100 INJECTION, SOLUTION, CONCENTRATE 5 mg INTRAVENOUS BLA 28 sections