dinutuximab 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
chimeric origin 4948 1363687-32-4

Description:

MoleculeDescription

Synonyms:

  • dinutuximab
  • unituxin
  • ch14.18
  • ch14.18-UTC
a human-mouse chimeric monoclonal antibody directed against disialoganglioside (GD2); used for treatment of refractory neuroblastoma & osteosarcoma
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Aug. 14, 2015 EMA United Therapeutics Europe Ltd
March 10, 2015 FDA UNITED THERAP
June 23, 2021 PMDA OHARA PHARMACEUTICAL Co.,Ltd.

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
Neuroblastoma recurrent 80.29 47.62 10 891 75 63488046
Hypoalbuminaemia 61.86 47.62 17 884 11788 63476333
Pyrexia 54.33 47.62 48 853 470430 63017691
Capillary leak syndrome 47.78 47.62 10 891 2190 63485931

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
Pyrexia 77.35 43.55 73 1091 332940 34622827
Hypoalbuminaemia 54.66 43.55 19 1145 12155 34943612
Hypoxia 53.21 43.55 29 1135 55066 34900701
Cardiotoxicity 50.97 43.55 15 1149 5633 34950134
Capillary leak syndrome 49.01 43.55 12 1152 2246 34953521
Myelitis transverse 45.82 43.55 10 1154 1130 34954637
Thrombotic microangiopathy 45.44 43.55 16 1148 10614 34945153

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
Pyrexia 121.49 44.89 115 1939 678594 79063740
Hypoalbuminaemia 107.14 44.89 34 2020 21263 79721071
Neuroblastoma recurrent 103.62 44.89 15 2039 200 79742134
Aspartate aminotransferase increased 75.58 44.89 46 2008 138595 79603739
Hypoxia 71.43 44.89 40 2014 103203 79639131
Capillary leak syndrome 70.29 44.89 17 2037 3908 79738426
Alanine aminotransferase increased 61.71 44.89 43 2011 162527 79579807
Myelitis transverse 59.34 44.89 13 2041 1934 79740400
Neuroblastoma 56.21 44.89 9 2045 241 79742093
Thrombotic microangiopathy 53.63 44.89 20 2034 20149 79722185
Face oedema 50.52 44.89 21 2033 28115 79714219
C-reactive protein increased 46.29 44.89 33 2021 128994 79613340
Abdominal pain 45.70 44.89 53 2001 389516 79352818

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
MeSH PA D000970 Antineoplastic Agents
FDA MoA N0000191499 Glycolipid Disialoganglioside-directed Antibody Interactions
FDA EPC N0000191500 Glycolipid Disialoganglioside-directed Antibody

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

DiseaseRelationSNOMED_IDDOID
Neuroblastoma indication 432328008 DOID:769




🐶 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
D10559 KEGG_DRUG
4034568 VUID
N0000191732 NUI
4034568 VANDF
CHEMBL2109420 ChEMBL_ID
CHEMBL3137342 ChEMBL_ID
C112746 MESH_SUPPLEMENTAL_RECORD_UI
7979 IUPHAR_LIGAND_ID
DB09077 DRUGBANK_ID
1606274 RXNORM
233210 MMSL
30928 MMSL
d08351 MMSL
016047 NDDF
724036009 SNOMEDCT_US
763590003 SNOMEDCT_US
C0281581 UMLSCUI
9754 INN_ID
7SQY4ZUD30 UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Unituxin HUMAN PRESCRIPTION DRUG LABEL 1 66302-014 INJECTION 3.50 mg INTRAVENOUS BLA 32 sections
Unituxin HUMAN PRESCRIPTION DRUG LABEL 1 66302-014 INJECTION 3.50 mg INTRAVENOUS BLA 32 sections
Unituxin HUMAN PRESCRIPTION DRUG LABEL 1 66302-014 INJECTION 3.50 mg INTRAVENOUS BLA 32 sections