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

Stem definition	Drug id	CAS RN
mouse origin	4915	853426-35-4

Description:

Molecule	Description
Synonyms: blinatumomab blincyto MEDI-538 MT-103	a single-chain bispecific recombinant antibody from Micromet's BiTE (bispecific T-cell engager) product platform that binds both the CD19 antigen and the T-cell receptor (CD3), for the potential treatment of B-cell lymphoma Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

blinatumomab
blincyto
MEDI-538
MT-103

a single-chain bispecific recombinant antibody from Micromet's BiTE (bispecific T-cell engager) product platform that binds both the CD19 antigen and the T-cell receptor (CD3), for the potential treatment of B-cell lymphoma

Molecular weight:
Formula:
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA:
ALOGS:
ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

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Date	Agency	Company
Dec. 3, 2014	FDA	AMGEN
Nov. 23, 2015	EMA	Amgen Europe B.V.
Sept. 21, 2018	PMDA	Amgen Astellas Biopharma KK

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FDA Adverse Event Reporting System (Female)

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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
Acute lymphocytic leukaemia recurrent	1163.24	27.78	198	5632	2071	63481121
Cytokine release syndrome	974.16	27.78	232	5598	14082	63469110
Neurotoxicity	542.94	27.78	151	5679	16839	63466353
Pyrexia	368.66	27.78	319	5511	470159	63013033
Central nervous system leukaemia	202.11	27.78	30	5800	113	63483079
Leukaemic infiltration extramedullary	169.66	27.78	24	5806	58	63483134
Blast cell count increased	116.38	27.78	22	5808	424	63482768
Acute lymphocytic leukaemia refractory	106.04	27.78	16	5814	69	63483123
Neoplasm recurrence	100.57	27.78	27	5803	2611	63480581
Graft versus host disease in skin	97.99	27.78	27	5803	2878	63480314

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FDA Adverse Event Reporting System (Male)

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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
Cytokine release syndrome	858.62	24.40	281	7429	22596	34926625
Acute lymphocytic leukaemia recurrent	818.00	24.40	178	7532	2866	34946355
Neurotoxicity	389.14	24.40	147	7563	17863	34931358
Pyrexia	358.49	24.40	400	7310	332613	34616608
Central nervous system leukaemia	199	24.40	37	7673	249	34948972
Blast cell count increased	191.31	24.40	45	7665	1033	34948188
Leukaemic infiltration extramedullary	185.08	24.40	30	7680	75	34949146
Acute lymphocytic leukaemia refractory	105.23	24.40	19	7691	106	34949115
Minimal residual disease	103.05	24.40	23	7687	414	34948807
Acute lymphocytic leukaemia	81.07	24.40	29	7681	3000	34946221

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FDA Adverse Event Reporting System (Geriatric)

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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
Acute lymphocytic leukaemia recurrent	1553.43	23.24	307	11972	4417	79727692
Cytokine release syndrome	1410.27	23.24	420	11859	35578	79696531
Neurotoxicity	645.83	23.24	227	12052	32291	79699818
Pyrexia	538.46	23.24	586	11693	678123	79053986
Central nervous system leukaemia	315.43	23.24	55	12224	371	79731738
Leukaemic infiltration extramedullary	276.86	23.24	44	12235	151	79731958
Blast cell count increased	222.29	23.24	50	12229	1360	79730749
Acute lymphocytic leukaemia refractory	160.40	23.24	27	12252	143	79731966
Acute lymphocytic leukaemia	151.52	23.24	48	12231	4921	79727188
Febrile neutropenia	138.59	23.24	174	12105	230825	79501284

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	L01FX07	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES Other monoclonal antibodies and antibody drug conjugates
FDA CS	M0018640	Recombinant Fusion Proteins
FDA EPC	N0000191421	Bispecific CD19-directed CD3-directed T Cell Engager
FDA MoA	N0000175617	CD3-directed Antibody Interactions
FDA MoA	N0000175618	CD3 Receptor Agonists
FDA MoA	N0000191422	CD19-directed Antibody Interactions
MeSH PA	D000970	Antineoplastic Agents

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

Disease	Relation	SNOMED_ID	DOID
Pre B-cell acute lymphoblastic leukemia	indication	277572006

🐶 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:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
B-lymphocyte antigen CD19	Surface antigen	P15391	CD19_HUMAN	ANTIBODY BINDING	Kd	9		IUPHAR	DRUG LABEL
T-cell surface glycoprotein CD3	Surface antigen	P07766 P09693 P04234	CD3E_HUMAN CD3G_HUMAN CD3D_HUMAN	ANTIBODY BINDING	Kd	7		IUPHAR	DRUG LABEL

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External reference:

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ID	Source
015799	NDDF
1597258	RXNORM
231126	MMSL
30709	MMSL
4033958	VUID
4033958	VANDF
4FR53SIF3A	UNII
716122004	SNOMEDCT_US
7384	IUPHAR_LIGAND_ID
774173007	SNOMEDCT_US

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Pharmaceutical products:

None