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

Stem definitionDrug idCAS RN
humanized origin 5055 1362509-93-0

Description:

MoleculeDescription

Synonyms:

  • idarucizumab
  • praxbind
  • BI 655075
  • BI-655075
an anticoagulant reversal agent that targets dabigatran
  • 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
Oct. 16, 2015 FDA BOEHRINGER INGELHEIM
Nov. 20, 2015 EMA Boehringer Ingelheim International GmbH

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
Haemorrhage 130.26 81.84 41 814 69328 90558264
Death 109.65 81.84 62 793 456489 90171103
Cerebral haemorrhage 106.54 81.84 30 825 34492 90593100
Multiple organ dysfunction syndrome 102.13 81.84 34 821 68302 90559290
Shock haemorrhagic 83.43 81.84 20 835 12225 90615367

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
Cerebral haemorrhage 109.69 59.15 42 1254 38924 42581115
Haemorrhage 104.63 59.15 46 1250 60517 42559522
Death 68.37 59.15 77 1219 471108 42148931
Haemorrhage intracranial 64.75 59.15 23 1273 17169 42602870
Gastrointestinal haemorrhage 62.29 59.15 38 1258 97688 42522351

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
Haemorrhage 203.35 61.75 77 2111 106615 110480496
Cerebral haemorrhage 200.18 61.75 67 2121 64901 110522210
Death 142.66 61.75 114 2074 698755 109888356
Shock haemorrhagic 124.57 61.75 38 2150 27209 110559902
Multiple organ dysfunction syndrome 123.46 61.75 60 2128 151650 110435461
Haemorrhage intracranial 118.08 61.75 37 2151 28932 110558179
Gastrointestinal haemorrhage 109.78 61.75 57 2131 165461 110421650
Cerebral infarction 100.61 61.75 38 2150 51800 110535311
Haemorrhagic transformation stroke 90.51 61.75 19 2169 3018 110584093
Ischaemic stroke 86.44 61.75 32 2156 41231 110545880
Subdural haematoma 75.34 61.75 28 2160 36426 110550685
Coagulopathy 72.20 61.75 28 2160 40883 110546228

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC V03AB37 VARIOUS
ALL OTHER THERAPEUTIC PRODUCTS
ALL OTHER THERAPEUTIC PRODUCTS
Antidotes
FDA CS M0556300 Antibodies, Monoclonal, Humanized
FDA EPC N0000191873 Humanized Monoclonal Antibody Fragment

Related Drugs by ATC class:

V03AB Antidotes 28 drugs
4-dimethylaminophenolacetylcysteineamyl nitriteandexanet alfaatropinecopper sulfatedimercaprolethanolflumazenilfomepizoleglutathionehydroxocobalamin show all 28 →

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

DiseaseRelationSNOMED_IDDOID
Drug-induced coagulation inhibitor disorder indication 16773005




🐶 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
97RWB5S1U6 UNII
D10741 KEGG_DRUG
4034988 VANDF
C3885063 UMLSCUI
CHEBI:755412 CHEBI
CHEMBL3544996 ChEMBL_ID
DB09264 DRUGBANK_ID
9698 INN_ID
C000594745 MESH_SUPPLEMENTAL_RECORD_UI
8298 IUPHAR_LIGAND_ID
1716191 RXNORM
236513 MMSL
31242 MMSL
d08387 MMSL
016531 NDDF
716017002 SNOMEDCT_US
763599002 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Praxbind HUMAN PRESCRIPTION DRUG LABEL 1 0597-0197 INJECTION 50 mg INTRAVENOUS BLA 26 sections