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

Stem definitionDrug idCAS RN
enzymes 4989 884604-91-5

Description:

MoleculeDescription

Synonyms:

  • velaglucerase alfa
  • vpriv
  • EC 3.2.1.45
produced by gene activation technology in a human fibroblast cell line and has the same amino acid sequence as the naturally occurring human enzyme glucocerebrosidase
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
300 U P

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
Feb. 26, 2010 FDA SHIRE HUMAN GENETIC
Aug. 26, 2010 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
Inappropriate schedule of product administration 109.90 31.78 51 1348 149882 90477166
Poor venous access 60.16 31.78 19 1380 19508 90607540
Product dose omission issue 56.80 31.78 42 1357 291645 90335403
No adverse event 49.23 31.78 23 1376 67959 90559089
Abortion spontaneous 47.72 31.78 21 1378 54035 90573013
Exposure during pregnancy 45.61 31.78 34 1365 238376 90388672
Pregnancy 44.94 31.78 21 1378 62026 90565022
Cholangiocarcinoma 39.93 31.78 8 1391 1295 90625753
COVID-19 36.61 31.78 26 1373 168817 90458231

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
Inappropriate schedule of product administration 101.21 35.75 54 1410 95848 42524023
Bone pain 68.49 35.75 27 1437 23765 42596106
Weight fluctuation 67.44 35.75 19 1445 5932 42613939
Poor venous access 59.40 35.75 18 1446 7234 42612637
COVID-19 45.38 35.75 35 1429 115913 42503958
Infusion related reaction 44.40 35.75 27 1437 60779 42559092
Product dose omission issue 40.53 35.75 37 1427 154328 42465543
Weight increased 36.66 35.75 30 1434 107953 42511918

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
Inappropriate schedule of product administration 172.11 30.44 87 2491 203550 110383171
Poor venous access 93.54 30.44 31 2547 24491 110562230
Product dose omission issue 90.12 30.44 68 2510 321714 110265007
Bone pain 89.38 30.44 39 2539 65094 110521627
Weight fluctuation 80.49 30.44 27 2551 22118 110564603
COVID-19 66.76 30.44 51 2527 245009 110341712
Blood pressure increased 40.09 30.44 39 2539 258334 110328387
Blood pressure abnormal 39.31 30.44 16 2562 22408 110564313
Product availability issue 34.21 30.44 11 2567 7879 110578842
Irregular sleep phase 30.83 30.44 5 2573 161 110586560
Weight increased 30.66 30.44 43 2535 419601 110167120

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A16AB10 ALIMENTARY TRACT AND METABOLISM
OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
Enzymes
FDA EPC N0000175820 Hydrolytic Lysosomal Glucocerebroside-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
Chronic non-neuropathic Gaucher's disease indication 62201009




🐶 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
23HYE36B0I UNII
D09029 KEGG_DRUG
4029768 VUID
N0000180860 NUI
4029768 VANDF
C2919267 UMLSCUI
CHEBI:747652 CHEBI
CHEMBL1201865 ChEMBL_ID
DB06720 DRUGBANK_ID
8925 INN_ID
7464 IUPHAR_LIGAND_ID
901805 RXNORM
171696 MMSL
27053 MMSL
d07588 MMSL
013387 NDDF
444773003 SNOMEDCT_US
445499001 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
VPRIV HUMAN PRESCRIPTION DRUG LABEL 1 54092-701 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 2.50 mg INTRAVENOUS BLA 25 sections