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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
April 30, 2003 FDA BIOMARIN
June 10, 2003 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
Urinary glycosaminoglycans increased 58.88 29.78 6 1822 0 90626619
Pyrexia 58.67 29.78 69 1759 660416 89966203
Stem cell transplant 44.46 29.78 10 1818 2144 90624475
Cyanosis 36.49 29.78 14 1814 19441 90607178
Poor venous access 36.44 29.78 14 1814 19513 90607106
Pneumonia 35.33 29.78 53 1775 638006 89988613
Hydrocephalus 34.14 29.78 10 1818 6084 90620535
Respiratory failure 33.89 29.78 24 1804 118394 90508225
Respiratory distress 33.07 29.78 16 1812 38930 90587689
Pallor 31.95 29.78 15 1813 34150 90592469
Chills 31.56 29.78 24 1804 131957 90494662

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 62.78 34.37 38 1644 73998 42545655
Poor venous access 48.74 34.37 16 1666 7236 42612417
Corneal transplant 45.25 34.37 7 1675 95 42619558
Drug specific antibody present 40.15 34.37 12 1670 3994 42615659
Corneal opacity 37.80 34.37 8 1674 657 42618996
Pyrexia 34.44 34.37 58 1624 393984 42225669

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
Urinary glycosaminoglycans increased 74.68 30.22 8 3586 0 110585705
Pyrexia 74.30 30.22 116 3478 898149 109687556
Poor venous access 72.56 30.22 28 3566 24494 110561211
Bone marrow transplant 69.50 30.22 15 3579 1645 110584060
Cyanosis 63.97 30.22 27 3567 29714 110555991
Respiratory distress 63.63 30.22 35 3559 68839 110516866
Drug specific antibody present 61.86 30.22 19 3575 8415 110577290
Respiratory failure 55.58 30.22 50 3544 215282 110370423
Spinal cord compression 55.33 30.22 17 3577 7535 110578170
Stem cell transplant 54.88 30.22 15 3579 4412 110581293
Hydrocephalus 53.98 30.22 18 3576 10357 110575348
Oxygen saturation decreased 53.96 30.22 43 3551 156939 110428766
Illness 45.34 30.22 30 3564 82141 110503564
Corneal transplant 42.95 30.22 8 3586 415 110585290
Urticaria 40.87 30.22 51 3543 318806 110266899
Pneumonia 39.09 30.22 87 3507 876627 109709078
Pallor 37.05 30.22 23 3571 56444 110529261
Irritability 35.29 30.22 21 3573 47788 110537917
Cardio-respiratory arrest 32.03 30.22 28 3566 115808 110469897
Tachycardia 31.85 30.22 38 3556 226607 110359098
Cardiopulmonary failure 30.60 30.22 11 3583 7892 110577813
Graft versus host disease 30.48 30.22 14 3580 18792 110566913
Body temperature increased 30.23 30.22 20 3574 54693 110531012

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

Related Drugs by ATC class:

A16AB Enzymes 24 drugs
agalsidase alfaagalsidase betaalglucerasealglucosidase alfaasfotase alfaavalglucosidase alfacerliponase alfacipaglucosidase alfaeladocagene exuparvovecelosulfase alfagalsulfaseidursulfase show all 24 →

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
CHEBI:749444 CHEBI
CHEMBL1201595 ChEMBL_ID
C000732080 MESH_SUPPLEMENTAL_RECORD_UI
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 28 sections