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

Stem definition	Drug id	CAS RN
humanized origin	4983	949142-50-1

Description:

Molecule	Description
Synonyms: gazyva RO-5072759 RO 5072759 obinutuzumab huMAB<CD20> GA101 gazyvaro	anti-CD20 mAb for treating B-cell lymphoid cancers Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

gazyva
RO-5072759
RO 5072759
obinutuzumab
huMAB<CD20>
GA101
gazyvaro

anti-CD20 mAb for treating B-cell lymphoid cancers

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
July 2, 2018	PMDA	Chugai Pharmaceutical Co., Ltd.
July 23, 2014	EMA
Nov. 1, 2013	FDA	GENENTECH

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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
Febrile neutropenia	380.08	27.09	218	7939	118231	63362634
Myelosuppression	354.53	27.09	128	8029	23575	63457290
Neutropenia	327.61	27.09	229	7928	174776	63306089
COVID-19	325.29	27.09	194	7963	112909	63367956
Thrombocytopenia	250.84	27.09	184	7973	150973	63329892
Tumour lysis syndrome	210.56	27.09	68	8089	8922	63471943
Infusion related reaction	197.11	27.09	197	7960	245324	63235541
Cytokine release syndrome	179.61	27.09	68	8089	14246	63466619
Pyrexia	145.05	27.09	234	7923	470244	63010621
Disease progression	137.92	27.09	119	8038	122639	63358226

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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
Infusion related reaction	443.77	21.86	264	12685	52793	34891189
COVID-19	368.22	21.86	271	12678	77279	34866703
Myelosuppression	339.41	21.86	158	12791	19107	34924875
Tumour lysis syndrome	273.06	21.86	131	12818	16928	34927054
Febrile neutropenia	265.20	21.86	288	12661	136561	34807421
Neutropenia	244.71	21.86	295	12654	156483	34787499
COVID-19 pneumonia	169.58	21.86	95	12854	16872	34927110
End stage renal disease	169.45	21.86	77	12872	8784	34935198
Chills	167.91	21.86	177	12772	80866	34863116
Disease progression	162.74	21.86	200	12749	107877	34836105

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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
Myelosuppression	673.59	21.96	278	18415	40018	79685677
COVID-19	631.90	21.96	416	18277	157258	79568437
Febrile neutropenia	617.63	21.96	476	18217	230523	79495172
Neutropenia	483.18	21.96	454	18239	287256	79438439
Infusion related reaction	442.32	21.96	392	18301	229845	79495850
Tumour lysis syndrome	423.05	21.96	172	18521	23767	79701928
Cytokine release syndrome	293.54	21.96	151	18542	35847	79689848
COVID-19 pneumonia	282.39	21.96	137	18556	28712	79696983
Pyrexia	248.91	21.96	512	18181	678197	79047498
Thrombocytopenia	239.01	21.96	302	18391	264957	79460738

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	L01FA03	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES CD20 (Clusters of Differentiation 20) inhibitors
FDA EPC	N0000175657	CD20-directed Cytolytic Antibody
FDA MoA	N0000175078	CD20-directed Antibody Interactions
MeSH PA	D000970	Antineoplastic Agents
MeSH PA	D000074322	Antineoplastic Agents, Immunological

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

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Disease	Relation	SNOMED_ID	DOID
CD20-positive follicular lymphoma	indication	55150002
Chronic lymphoid leukemia, disease	indication	92814006

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🐶 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 CD20	Surface antigen	P11836	CD20_HUMAN	ANTIBODY BINDING				DRUG LABEL	DRUG LABEL

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External reference:

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ID	Source
015268	NDDF
14160522	PUBCHEM_CID
1442694	RXNORM
206788	MMSL
29767	MMSL
4032842	VUID
4032842	VANDF
6941	IUPHAR_LIGAND_ID
710287009	SNOMEDCT_US
715547003	SNOMEDCT_US

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Gazyva	HUMAN PRESCRIPTION DRUG LABEL	1	50242-070	INJECTION, SOLUTION, CONCENTRATE	1000 mg	INTRAVENOUS	BLA	31 sections
Gazyva	HUMAN PRESCRIPTION DRUG LABEL	1	50242-070	INJECTION, SOLUTION, CONCENTRATE	1000 mg	INTRAVENOUS	BLA	31 sections
Gazyva	HUMAN PRESCRIPTION DRUG LABEL	1	50242-070	INJECTION, SOLUTION, CONCENTRATE	1000 mg	INTRAVENOUS	BLA	31 sections

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