laronidase 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
enzymes 4997 210589-09-6

Description:

MoleculeDescription

Synonyms:

  • laronidase
  • aldurazyme
  • laronidase (genetical recombination)
Laronidase is a polymorphic variant of the human enzyme alpha‑l‑iduronidase that is produced by recombinant DNA technology which catalyzes the hydrolysis of terminal alpha-l-iduronic acid residues of dermatan sulfate and heparan sulfate. Reduced or absent alpha-L-iduronidase activity results in the accumulation of the glycosaminoglycans (GAG) substrates, dermatan sulfate and heparan sulfate, throughout the body and leads to widespread cellular, tissue, and organ dysfunction.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
1 TU P

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
June 10, 2003 EMA
April 30, 2003 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
Stem cell transplant 44.46 28.47 10 1504 1812 63485696
Pyrexia 44.30 28.47 55 1459 470423 63017085
Urinary glycosaminoglycans increased 38.58 28.47 4 1510 0 63487508
Cyanosis 36.11 28.47 14 1500 16921 63470587
Hydrocephalus 33.87 28.47 10 1504 5290 63482218
Respiratory failure 31.27 28.47 23 1491 101835 63385673
Pneumonia 30.12 28.47 45 1469 456722 63030786
Respiratory distress 29.67 28.47 15 1499 33936 63453572

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
Urticaria 62.32 40.67 35 1281 62342 34893273

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
Respiratory distress 62.41 31.15 34 2885 58305 79683164
Cyanosis 61.86 31.15 26 2893 25156 79716313
Pyrexia 60.88 31.15 97 2822 678612 79062857
Respiratory failure 56.00 31.15 49 2870 180862 79560607
Stem cell transplant 55.77 31.15 15 2904 3689 79737780
Bone marrow transplant 53.15 31.15 12 2907 1436 79740033
Urticaria 53.03 31.15 48 2871 185153 79556316
Hydrocephalus 50.60 31.15 17 2902 8883 79732586
Urinary glycosaminoglycans increased 46.08 31.15 5 2914 0 79741469
Poor venous access 45.44 31.15 19 2900 18130 79723339
Oxygen saturation decreased 44.06 31.15 37 2882 129010 79612459
Corneal transplant 37.21 31.15 7 2912 340 79741129
Infusion related reaction 35.71 31.15 43 2876 230194 79511275
Spinal cord compression 35.54 31.15 12 2907 6365 79735104
Pneumonia 32.28 31.15 73 2846 660173 79081296
Tachycardia 32.24 31.15 36 2883 177732 79563737
Pallor 32.11 31.15 21 2898 50041 79691428
Graft versus host disease 31.90 31.15 14 2905 15012 79726457

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A16AB05 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

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

DiseaseRelationSNOMED_IDDOID
Mucopolysaccharidosis, MPS-I indication 75610003 DOID:12802




🐶 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
D04670 KEGG_DRUG
4021389 VUID
N0000148807 NUI
4021389 VANDF
CHEMBL1201595 ChEMBL_ID
DB00090 DRUGBANK_ID
392509 RXNORM
17247 MMSL
46700 MMSL
d04867 MMSL
009982 NDDF
398789008 SNOMEDCT_US
409264006 SNOMEDCT_US
C1302054 UMLSCUI
8015 INN_ID
WP58SVM6R4 UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
ALDURAZYME HUMAN PRESCRIPTION DRUG LABEL 1 58468-0070 INJECTION, SOLUTION, CONCENTRATE 2.90 mg INTRAVENOUS BLA 25 sections
ALDURAZYME HUMAN PRESCRIPTION DRUG LABEL 1 58468-0070 INJECTION, SOLUTION, CONCENTRATE 2.90 mg INTRAVENOUS BLA 25 sections