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

Stem definition	Drug id	CAS RN
chimeric origin	4948	1363687-32-4

Description:

Molecule

Description

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:

Date	Agency	Company	Orphan
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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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:

Source	Code	Description
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|

Disease	Relation	SNOMED_ID	DOID
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:

ID	Source
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:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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