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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

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)

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
Hypoalbuminaemia 102.78 45.63 26 1041 15871 90611509
Neuroblastoma recurrent 91.44 45.63 12 1055 173 90627207
Pyrexia 75.91 45.63 62 1005 660423 89966957
Capillary leak syndrome 71.01 45.63 14 1053 2753 90624627
Aspartate aminotransferase increased 64.66 45.63 29 1038 102908 90524472
Alanine aminotransferase increased 57.74 45.63 28 1039 118310 90509070

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 97.84 40.82 93 1447 393949 42225846
Neuroblastoma recurrent 95.78 40.82 16 1524 396 42619399
Hypoalbuminaemia 74.38 40.82 26 1514 15584 42604211
Capillary leak syndrome 60.66 40.82 15 1525 2692 42617103
Aspartate aminotransferase increased 49.16 40.82 32 1508 77131 42542664
Cardiotoxicity 45.66 40.82 15 1525 7430 42612365
Eyelid oedema 45.35 40.82 14 1526 5681 42614114
Hypoxia 44.58 40.82 29 1511 69757 42550038
Myelitis transverse 43.33 40.82 10 1530 1337 42618458
Mydriasis 43.25 40.82 15 1525 8755 42611040
Alanine aminotransferase increased 42.90 40.82 31 1509 88375 42531420
Thrombotic microangiopathy 42.45 40.82 17 1523 14765 42605030
Gamma-glutamyltransferase increased 40.87 40.82 21 1519 32476 42587319

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
Neuroblastoma recurrent 165.32 42.27 25 2518 515 110586241
Pyrexia 155.38 42.27 142 2401 898123 109688633
Hypoalbuminaemia 149.87 42.27 46 2497 28928 110557828
Aspartate aminotransferase increased 100.71 42.27 56 2487 159880 110426876
Alanine aminotransferase increased 90.87 42.27 55 2488 183718 110403038
Capillary leak syndrome 88.95 42.27 21 2522 4887 110581869
Gamma-glutamyltransferase increased 69.51 42.27 32 2511 61277 110525479
Hypoxia 67.15 42.27 40 2503 129475 110457281
Abdominal pain 60.03 42.27 66 2477 512923 110073833
Myelitis transverse 58.09 42.27 13 2530 2388 110584368
Eyelid oedema 57.26 42.27 19 2524 15243 110571513
Face oedema 56.01 42.27 23 2520 33446 110553310
Thrombotic microangiopathy 48.66 42.27 20 2523 29129 110557627
Urinary retention 48.17 42.27 26 2517 69657 110517099

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
CHEBI has role CHEBI:35610 antineoplastic agent

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
CHEBI:755169 CHEBI
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 33 sections
Unituxin HUMAN PRESCRIPTION DRUG LABEL 1 66302-014 INJECTION 3.50 mg INTRAVENOUS BLA 33 sections