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
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 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
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 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	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:

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
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:

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