defibrotide Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
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

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
Venoocclusive disease 172.59 78.93 29 707 2026 53346304
Venoocclusive liver disease 125.05 78.93 25 711 4547 53343783
Multiple organ dysfunction syndrome 111.98 78.93 38 698 55639 53292691
Death 97.02 78.93 60 676 357172 52991158

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
Venoocclusive disease 262.71 63.86 51 1264 2695 32509516
Venoocclusive liver disease 238.74 63.86 56 1259 7309 32504902
Multiple organ dysfunction syndrome 127.44 63.86 60 1255 69794 32442417
Off label use 111.49 63.86 94 1221 306226 32205985
Death 68.55 63.86 80 1235 382437 32129774

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

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Veno-occlusive disease of the liver indication 65617004

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)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
200MG/2.5ML (80MG/ML) DEFITELIO JAZZ PHARMS INC N208114 March 30, 2016 RX SOLUTION INTRAVENOUS March 30, 2023 FOR THE 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).

Bioactivity Summary:

None

External reference:

IDSource
D07423 KEGG_DRUG
4035614 VANDF
4035615 VANDF
C0057257 UMLSCUI
CHEMBL2108396 ChEMBL_ID
135565962 PUBCHEM_CID
DB04932 DRUGBANK_ID
CHEMBL3707226 ChEMBL_ID
C036901 MESH_SUPPLEMENTAL_RECORD_UI
9087 IUPHAR_LIGAND_ID
4876 INN_ID
L7CHH2B2J0 UNII
1311089 RXNORM
221104 MMSL
31588 MMSL
d06744 MMSL
010017 NDDF
016771 NDDF
441573002 SNOMEDCT_US
442263003 SNOMEDCT_US
717036000 SNOMEDCT_US

Pharmaceutical products:

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