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

FDA Adverse Event Reporting System (Female)

None

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
Thrombotic microangiopathy 53.20 45.62 16 723 8665 29565123
Cardiotoxicity 53.05 45.62 14 725 4730 29569058
Pyrexia 45.73 45.62 45 694 287577 29286211

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 72.09 39.26 72 1275 558572 63938813
Myelitis transverse 58.52 39.26 12 1335 1611 64495774
Thrombotic microangiopathy 49.57 39.26 17 1330 16638 64480747
Cardiotoxicity 44.78 39.26 14 1333 10260 64487125
Pancytopenia 44.76 39.26 31 1316 143278 64354107
Neuroblastoma recurrent 43.77 39.26 6 1341 66 64497319
Hypoxia 42.26 39.26 25 1322 88124 64409261

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 (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
9754 INN_ID
DB09077 DRUGBANK_ID
7SQY4ZUD30 UNII
1606274 RXNORM
233210 MMSL
30928 MMSL
d08351 MMSL
724036009 SNOMEDCT_US
763590003 SNOMEDCT_US
C0281581 UMLSCUI
016047 NDDF

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