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

Stem definitionDrug idCAS RN
peptides and glycopeptides 5092 83712-60-1

Description:

MoleculeDescription

Synonyms:

  • defibrotide
  • defibrotide sodium
  • JZP-381
  • defibrinotide
  • defitelio
Single-stranded polydeoxyribonucleotide extracted from mammalian organs and used in the treatment of HEPATIC VENO-OCCLUSIVE DISEASE in patients with kidney or lung abnormalities following HEMATOPOIETIC STEM CELL TRANSPLANTATION. The compound is a sodium salt.
  • Molecular weight:
  • Formula: None
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
1.75 g P

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
June 18, 2019 PMDA Nippon Shinyaku Co., Ltd.
Oct. 18, 2013 EMA Gentium S.r.l.
March 30, 2016 FDA GENTIUM SRL

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
Off label use 236.28 79.30 149 922 1102103 89525273
Multiple organ dysfunction syndrome 162.43 79.30 51 1020 68285 90559091
Death 130.12 79.30 75 996 456476 90170900
Graft versus host disease 87.02 79.30 20 1051 8124 90619252

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
Off label use 286.39 80.64 223 1577 638112 41981423
Multiple organ dysfunction syndrome 200.52 80.64 92 1708 96943 42522592
Cystitis haemorrhagic 117.02 80.64 32 1768 7297 42612238
Venoocclusive disease 95.79 80.64 24 1776 3891 42615644
Death 93.33 80.64 106 1694 471079 42148456
Gastrointestinal haemorrhage 84.52 80.64 52 1748 97674 42521861

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
Venoocclusive disease 1409.37 87.58 230 3103 6120 110579846
Off label use 953.22 87.58 566 2767 1499619 109086347
Multiple organ dysfunction syndrome 325.75 87.58 134 3199 151576 110434390
Death 222.39 87.58 176 3157 698693 109887273
Venoocclusive liver disease 166.78 87.58 46 3287 15161 110570805
Graft versus host disease 135.35 87.58 41 3292 18765 110567201
Acute graft versus host disease 123.12 87.58 35 3298 12846 110573120
Gastrointestinal haemorrhage 117.87 87.58 69 3264 165449 110420517
Hypotension 116.75 87.58 108 3225 523741 110062225
Acute myeloid leukaemia 106.97 87.58 41 3292 38069 110547897
Cystitis haemorrhagic 102.53 87.58 30 3303 12179 110573787

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC B01AX01 BLOOD AND BLOOD FORMING ORGANS
ANTITHROMBOTIC AGENTS
ANTITHROMBOTIC AGENTS
Other antithrombotic agents
MeSH PA D002317 Cardiovascular Agents
MeSH PA D005343 Fibrinolytic Agents
MeSH PA D006401 Hematologic Agents
MeSH PA D010975 Platelet Aggregation Inhibitors
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:50249 anticoagulant
CHEBI has role CHEBI:75835 anti-anaemic agent

Related Drugs by ATC class:

B01AX Other antithrombotic agents 3 drugs
caplacizumabdermatan sulfatefondaparinux

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

DiseaseRelationSNOMED_IDDOID
Veno-occlusive disease of the liver indication 65617004




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
200MG/2.5ML (80MG/ML) DEFITELIO JAZZ PHARMS INC N208114 March 30, 2016 RX SOLUTION INTRAVENOUS 11236328 June 22, 2032 TREATMENT OF ADULT AND PEDIATRIC PATIENTS WITH HEPATIC VENO-OCCLUSIVE DISEASE (VOD), ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME (SOS), WITH RENAL OR PULMONARY DYSFUNCTION FOLLOWING HEMATOPOIETIC STEM-CELL TRANSPLANTATION (HSCT)

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

IDSource
D07423 KEGG_DRUG
4035614 VANDF
4035615 VANDF
C0057257 UMLSCUI
CHEBI:753370 CHEBI
CHEMBL2108396 ChEMBL_ID
DB04932 DRUGBANK_ID
CHEMBL3707226 ChEMBL_ID
C036901 MESH_SUPPLEMENTAL_RECORD_UI
9087 IUPHAR_LIGAND_ID
1311089 RXNORM
221104 MMSL
31588 MMSL
d06744 MMSL
010017 NDDF
016771 NDDF
441573002 SNOMEDCT_US
442263003 SNOMEDCT_US
717036000 SNOMEDCT_US
4876 INN_ID
L7CHH2B2J0 UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
DEFITELIO HUMAN PRESCRIPTION DRUG LABEL 1 68727-800 INJECTION, SOLUTION 80 mg INTRAVENOUS NDA 25 sections