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:

Date	Agency	Company
July 23, 2014	EMA
Nov. 1, 2013	FDA	GENENTECH
July 2, 2018	PMDA	Chugai 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
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
Neutrophil count decreased	129.43	27.09	84	8073	56322	63424543
Off label use	127.93	27.09	272	7885	674190	62806675
COVID-19 pneumonia	94.78	27.09	43	8114	14166	63466699
Cytomegalovirus infection	93.10	27.09	48	8109	20904	63459961
Lymphocyte count decreased	81.73	27.09	50	8107	30207	63450658
Platelet count decreased	79.88	27.09	86	8071	116036	63364829
Pneumonia	76.84	27.09	176	7981	456591	63024274
Cytopenia	73.88	27.09	34	8123	11567	63469298
Chills	72.81	27.09	81	8076	113297	63367568
B-cell lymphoma recurrent	69.73	27.09	15	8142	398	63480467
Lymphoma	69.22	27.09	33	8124	12154	63468711
Hypogammaglobulinaemia	68.62	27.09	28	8129	7127	63473738
Pneumonitis	62.99	27.09	45	8112	35177	63445688
Pancytopenia	56.69	27.09	66	8091	96867	63383998
Blood lactate dehydrogenase increased	49.49	27.09	33	8124	23083	63457782
Hypertensive cardiomyopathy	49.00	27.09	10	8147	204	63480661
Cytomegalovirus chorioretinitis	47.89	27.09	15	8142	1778	63479087
Progressive multifocal leukoencephalopathy	44.40	27.09	25	8132	12946	63467919
Pain	44.31	27.09	20	8137	740608	62740257
Neutropenic infection	43.14	27.09	13	8144	1354	63479511
Chronic lymphocytic leukaemia recurrent	41.98	27.09	9	8148	235	63480630
Post-acute COVID-19 syndrome	41.91	27.09	10	8147	426	63480439
Listeria sepsis	41.44	27.09	11	8146	724	63480141
Atrial fibrillation	39.75	27.09	61	8096	116575	63364290
White blood cell count decreased	39.56	27.09	67	8090	139037	63341828
Lymphoma transformation	39.44	27.09	8	8149	158	63480707
Obliterative bronchiolitis	37.69	27.09	13	8144	2082	63478783
Blood disorder	37.42	27.09	18	8139	6753	63474112
Serum sickness	37.34	27.09	14	8143	2846	63478019
Blood immunoglobulin G decreased	31.98	27.09	12	8145	2446	63478419
Hypertransaminasaemia	31.84	27.09	16	8141	6593	63474272
Vaccination failure	31.63	27.09	9	8148	767	63480098
Sepsis	31.29	27.09	64	8093	153059	63327806
Follicular lymphoma	31.16	27.09	7	8150	228	63480637
Lymphadenopathy	30.91	27.09	31	8126	38427	63442438
Abdominal discomfort	30.46	27.09	3	8154	320882	63159983
Condition aggravated	28.87	27.09	8	8149	402209	63078656
Chronic lymphocytic leukaemia refractory	28.20	27.09	5	8152	46	63480819

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
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
Pyrexia	126.83	21.86	337	12612	332676	34611306
Cytokine release syndrome	126.67	21.86	88	12861	22789	34921193
Lymphocyte count decreased	120.54	21.86	85	12864	22537	34921445
Off label use	101.20	21.86	362	12587	419162	34524820
Pneumonia	85.64	21.86	311	12638	362316	34581666
Neutrophil count decreased	85.63	21.86	100	12849	51004	34892978
Cytomegalovirus infection	82.30	21.86	72	12877	26063	34917919
Basal cell carcinoma	76.05	21.86	61	12888	19597	34924385
Thrombocytopenia	75.93	21.86	174	12775	156073	34787909
Lymphoma transformation	64.90	21.86	16	12933	261	34943721
B-cell lymphoma recurrent	64.45	21.86	20	12929	784	34943198
Blood lactate dehydrogenase increased	61.88	21.86	58	12891	22932	34921050
Cytopenia	56.84	21.86	43	12906	12680	34931302
Organic brain syndrome	54.98	21.86	14	12935	262	34943720
Chronic lymphocytic leukaemia recurrent	54.05	21.86	15	12934	395	34943587
Mantle cell lymphoma refractory	52.01	21.86	11	12938	86	34943896
Hypogammaglobulinaemia	50.53	21.86	33	12916	7707	34936275
Squamous cell carcinoma	49.53	21.86	38	12911	11437	34932545
Toxicity to various agents	48.57	21.86	8	12941	200354	34743628
Intentional product use issue	47.60	21.86	82	12867	59734	34884248
Urge incontinence	45.43	21.86	14	12935	536	34943446
Lymphocyte count increased	45.31	21.86	23	12926	3342	34940640
Platelet count decreased	45.03	21.86	121	12828	119596	34824386
Lymphadenopathy	44.82	21.86	54	12895	28409	34915573
Cytomegalovirus chorioretinitis	43.91	21.86	23	12926	3566	34940416
Ill-defined disorder	43.12	21.86	38	12911	13871	34930111
Bladder hypertrophy	42.61	21.86	14	12935	661	34943321
Condition aggravated	39.79	21.86	11	12938	192185	34751797
Atrial fibrillation	37.57	21.86	115	12834	122278	34821704
Progressive multifocal leukoencephalopathy	37.11	21.86	30	12919	9734	34934248
White blood cell count decreased	34.39	21.86	95	12854	95350	34848632
Product dose omission issue	33.33	21.86	3	12946	119708	34824274
Febrile infection	32.38	21.86	16	12933	2195	34941787
Coronavirus infection	32.18	21.86	20	12929	4287	34939695
Blood immunoglobulin G decreased	31.98	21.86	14	12935	1459	34942523
Pancytopenia	31.64	21.86	92	12857	95065	34848917
Splenomegaly	31.16	21.86	33	12916	15084	34928898
Pneumonitis	30.35	21.86	49	12900	33829	34910153
Cytomegalovirus enterocolitis	30.18	21.86	12	12937	982	34943000
Retinitis viral	29.87	21.86	7	12942	91	34943891
Flushing	29.19	21.86	47	12902	32373	34911609
Cerebral aspergillosis	29.12	21.86	13	12936	1419	34942563
Diffuse large B-cell lymphoma	28.76	21.86	23	12926	7347	34936635
Hypotension	28.42	21.86	159	12790	221490	34722492
Arthralgia	28.03	21.86	14	12935	170027	34773955
Fatigue	27.86	21.86	60	12889	370593	34573389
Respiratory tract infection	25.63	21.86	34	12915	19678	34924304
Insomnia	25.48	21.86	4	12945	103903	34840079
Meningitis enteroviral	25.24	21.86	5	12944	27	34943955
Bronchopulmonary aspergillosis	25.04	21.86	29	12920	14630	34929352
Tumour flare	24.75	21.86	10	12939	853	34943129
Gallbladder polyp	24.10	21.86	8	12941	390	34943592
Abdominal neoplasm	24.04	21.86	8	12941	393	34943589
Sepsis	23.71	21.86	123	12826	166438	34777544
Overdose	23.51	21.86	3	12946	91056	34852926
Lymphoma	23.50	21.86	26	12923	12481	34931501
Pruritus allergic	22.82	21.86	7	12942	264	34943718
Peroneal nerve palsy	22.54	21.86	14	12935	2997	34940985
Initial insomnia	22.07	21.86	14	12935	3110	34940872
Weight increased	21.88	21.86	4	12945	93029	34850953

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
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
Pneumonia	199.48	21.96	461	18232	659785	79065910
Neutrophil count decreased	191.87	21.96	166	18527	93793	79631902
Chills	182.92	21.96	206	18487	160028	79565667
End stage renal disease	179.45	21.96	77	18616	12143	79713552
Disease progression	173.96	21.96	215	18478	184147	79541548
Cytomegalovirus infection	166.48	21.96	111	18582	42533	79683162
Lymphocyte count decreased	158.40	21.96	112	18581	47177	79678518
Off label use	139.76	21.96	497	18196	906718	78818977
Cytopenia	133.67	21.96	74	18619	20309	79705386
Hypogammaglobulinaemia	113.27	21.96	57	18636	12894	79712801
Platelet count decreased	111.77	21.96	179	18514	194485	79531210
Blood lactate dehydrogenase increased	91.82	21.96	75	18618	39095	79686600
Cytomegalovirus chorioretinitis	85.25	21.96	36	18657	5454	79720241
Atrial fibrillation	83.60	21.96	159	18534	197727	79527968
Basal cell carcinoma	80.20	21.96	68	18625	37307	79688388
Pneumonitis	79.32	21.96	84	18609	60776	79664919
B-cell lymphoma recurrent	78.17	21.96	22	18671	978	79724717
Progressive multifocal leukoencephalopathy	74.10	21.96	51	18642	20549	79705146
Condition aggravated	73.98	21.96	14	18679	501110	79224585
Squamous cell carcinoma	71.60	21.96	45	18648	15577	79710118
Pancytopenia	71.00	21.96	134	18559	165611	79560084
Lymphoma transformation	64.09	21.96	15	18678	315	79725380
Arthralgia	64.08	21.96	27	18666	571776	79153919
White blood cell count decreased	63.69	21.96	138	18555	188150	79537545
Blood immunoglobulin G decreased	61.89	21.96	25	18668	3384	79722311
Sepsis	57.86	21.96	166	18527	269262	79456433
Neutropenic infection	55.36	21.96	21	18672	2406	79723289
Lymphoma	55.31	21.96	40	18653	17420	79708275
Mantle cell lymphoma refractory	54.33	21.96	11	18682	113	79725582
Bronchopulmonary aspergillosis	52.89	21.96	43	18650	22251	79703444
Lymphadenopathy	51.54	21.96	63	18630	53184	79672511
Fatigue	49.68	21.96	89	18604	929638	78796057
Chronic lymphocytic leukaemia recurrent	49.49	21.96	14	18679	634	79725061
Respiratory tract infection	49.40	21.96	59	18634	48630	79677065
Pain	48.79	21.96	56	18637	703746	79021949
Post-acute COVID-19 syndrome	43.32	21.96	12	18681	503	79725192
Headache	41.13	21.96	56	18637	653716	79071979
Obliterative bronchiolitis	40.91	21.96	18	18675	3010	79722685
Hypoxia	39.93	21.96	80	18613	103163	79622532
Febrile infection	39.19	21.96	18	18675	3328	79722367
Vaccination failure	38.57	21.96	15	18678	1838	79723857
Toxicity to various agents	38.24	21.96	26	18667	421514	79304181
Tumour flare	37.96	21.96	13	18680	1110	79724585
Alopecia	37.38	21.96	5	18688	231350	79494345
Hypotension	37.11	21.96	202	18491	440115	79285580
Abdominal discomfort	36.95	21.96	7	18686	250720	79474975
Cytomegalovirus enterocolitis	36.60	21.96	14	18679	1641	79724054
Bone marrow failure	36.36	21.96	52	18641	51055	79674640
Nasopharyngitis	35.53	21.96	8	18685	253873	79471822
Pain in extremity	35.09	21.96	21	18672	364517	79361178
Meningitis enteroviral	34.48	21.96	7	18686	73	79725622
Listeria sepsis	34.37	21.96	11	18682	761	79724934
Product dose omission issue	34.24	21.96	8	18685	247529	79478166
Neutropenic sepsis	32.86	21.96	36	18657	27028	79698667
Coronavirus infection	32.86	21.96	21	18672	7476	79718219
Diffuse large B-cell lymphoma recurrent	32.39	21.96	17	18676	4190	79721505
Agranulocytosis	32.30	21.96	46	18647	44984	79680711
Cerebral aspergillosis	32.02	21.96	13	18680	1783	79723912
Serum sickness	31.65	21.96	16	18677	3650	79722045
Blood disorder	30.98	21.96	21	18672	8252	79717443
Septic shock	30.63	21.96	80	18613	122721	79602974
Organic brain syndrome	30.48	21.96	9	18684	475	79725220
Retinitis viral	30.23	21.96	7	18686	140	79725555
Swelling	29.98	21.96	7	18686	216704	79508991
Colitis	29.78	21.96	58	18635	73249	79652446
Overdose	29.71	21.96	4	18689	184202	79541493
Weight increased	29.59	21.96	14	18679	277372	79448323
Insomnia	28.34	21.96	11	18682	245159	79480536
Intentional product use issue	28.14	21.96	89	18604	152023	79573672
Follicular lymphoma	27.95	21.96	8	18685	378	79725317
Epididymitis	27.79	21.96	12	18681	1918	79723777
Bladder hypertrophy	27.74	21.96	9	18684	650	79725045
Somnolence	27.17	21.96	11	18682	238970	79486725
Squamous cell carcinoma of skin	27.00	21.96	24	18669	14009	79711686
Cytomegalovirus test positive	26.92	21.96	17	18676	5930	79719765
Urge incontinence	26.77	21.96	10	18683	1098	79724597
Borrelia infection	26.35	21.96	7	18686	250	79725445
Gait disturbance	26.25	21.96	8	18685	207498	79518197
Myelodysplastic syndrome	24.81	21.96	33	18660	30268	79695427
Aspartate aminotransferase increased	24.63	21.96	80	18613	138561	79587134
B-cell lymphoma refractory	24.60	21.96	6	18687	151	79725544
Contusion	24.54	21.96	3	18690	148773	79576922
Fall	23.92	21.96	49	18644	487580	79238115
Hepatocellular injury	23.54	21.96	41	18652	47552	79678143
Therapeutic product effect decreased	23.25	21.96	5	18688	163858	79561837
Febrile bone marrow aplasia	22.56	21.96	21	18672	12999	79712696
Herpes zoster	22.55	21.96	60	18633	93023	79632672
Transaminases increased	22.32	21.96	42	18651	51701	79673994
Feeling abnormal	22.30	21.96	5	18688	159194	79566501
Malignant neoplasm of orbit	22.27	21.96	4	18689	20	79725675
Hypertransaminasaemia	22.16	21.96	20	18673	11904	79713791

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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

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

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

🐶 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:

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

External reference:

ID	Source
D09321	KEGG_DRUG
4032842	VUID
N0000189499	NUI
4032842	VANDF
CHEMBL1743048	ChEMBL_ID
C543332	MESH_SUPPLEMENTAL_RECORD_UI
6941	IUPHAR_LIGAND_ID
DB08935	DRUGBANK_ID
1442694	RXNORM
206788	MMSL
29767	MMSL
d08134	MMSL
015268	NDDF
710287009	SNOMEDCT_US
715547003	SNOMEDCT_US
C2742503	UMLSCUI
9043	INN_ID
14160522	PUBCHEM_CID
O43472U9X8	UNII

Pharmaceutical products:

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