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

Stem definitionDrug idCAS RN
enzymes 5101 552858-79-4

Description:

MoleculeDescription

Synonyms:

  • galsulfase
  • aryplase
  • naglazyme
  • galsulfase (genetical recombination)
a recombinant form of N-acetylgalactosamine-4-sulfatase
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

None

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
Jan. 24, 2006 EMA
May 31, 2005 FDA BIOMARIN

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
Spinal cord compression 153.82 46.69 28 769 4883 90622767
Cervical cord compression 153.15 46.69 19 778 235 90627415
Cervical spinal stenosis 115.49 46.69 20 777 2615 90625035
Corneal opacity 61.37 46.69 10 787 901 90626749
Pneumonia 53.17 46.69 44 753 638015 89989635

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
Spinal cord compression 142.33 41.66 28 632 4196 42616479
Cervical cord compression 102.71 41.66 14 646 205 42620470
Cervical spinal stenosis 57.64 41.66 11 649 1388 42619287

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
Cervical cord compression 177.75 38.78 24 1142 490 110587643
Spinal cord compression 160.40 38.78 32 1134 7520 110580613
Cervical spinal stenosis 142.60 38.78 25 1141 2917 110585216
Corneal opacity 49.78 38.78 9 1157 1242 110586891
Sleep apnoea syndrome 38.92 38.78 15 1151 40432 110547701

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A16AB08 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
agalsidase alfaagalsidase betaalglucerasealglucosidase alfaasfotase alfaavalglucosidase alfacerliponase alfacipaglucosidase alfaeladocagene exuparvovecelosulfase alfaidursulfaseidursulfase beta show all 24 →

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

DiseaseRelationSNOMED_IDDOID
Maroteaux-Lamy syndrome indication 69463008




🐶 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
59UA429E5G UNII
D06565 KEGG_DRUG
4024918 VANDF
C1615657 UMLSCUI
CHEBI:749598 CHEBI
CHEMBL1201822 ChEMBL_ID
DB01279 DRUGBANK_ID
8567 INN_ID
C508864 MESH_SUPPLEMENTAL_RECORD_UI
578033 RXNORM
20500 MMSL
71096 MMSL
d05634 MMSL
010814 NDDF
419797001 SNOMEDCT_US
420241006 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
NAGLAZYME HUMAN PRESCRIPTION DRUG LABEL 1 68135-020 SOLUTION 5 mg INTRAVENOUS BLA 26 sections