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

Stem definition	Drug id	CAS RN
humanized origin	5223	637334-45-3

Description:

Molecule	Description
Synonyms: ocrelizumab PR070769 ocrevus	The precise mechanism by which ocrelizumab exerts its therapeutic effects in multiple sclerosis is unknown, but is presumed to involve binding to CD20, a cell surface antigen present on pre-B and mature B lymphocytes. Following cell surface binding to B lymphocytes, ocrelizumab results in antibody-dependent cellular cytolysis and complement-mediated lysis. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

ocrelizumab
PR070769
ocrevus

The precise mechanism by which ocrelizumab exerts its therapeutic effects in multiple sclerosis is unknown, but is presumed to involve binding to CD20, a cell surface antigen present on pre-B and mature B lymphocytes. Following cell surface binding to B lymphocytes, ocrelizumab results in antibody-dependent cellular cytolysis and complement-mediated lysis.

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

Drug dosage:

Dose	Unit	Route
3.29	mg	P

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
Aug. 1, 2018	EMA	Roche Registration GmbH
March 28, 2017	FDA	GENENTECH INC

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
COVID-19	5639.69	16.26	2165	32873	110938	63343046
Multiple sclerosis relapse	875.08	16.26	459	34579	48019	63405965
Throat irritation	779.28	16.26	391	34647	37256	63416728
Urinary tract infection	623.35	16.26	747	34291	263937	63190047
Infusion related reaction	542.11	16.26	671	34367	244850	63209134
Multiple sclerosis	509.56	16.26	255	34783	24117	63429867
SARS-CoV-2 test positive	468.93	16.26	174	34864	7882	63446102
Herpes zoster	431.48	16.26	360	34678	82102	63371882
COVID-19 pneumonia	348.92	16.26	166	34872	14043	63439941
Oral herpes	320.31	16.26	192	34846	25882	63428102

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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
COVID-19	2700.94	21.28	998	10826	76552	34868555
Multiple sclerosis relapse	529.52	21.28	190	11634	12943	34932164
Multiple sclerosis	380.19	21.28	125	11699	6520	34938587
Urinary tract infection	368.60	21.28	270	11554	83811	34861296
JC polyomavirus test positive	223.56	21.28	51	11773	646	34944461
SARS-CoV-2 test positive	220.80	21.28	81	11743	5852	34939255
Infusion related reaction	211.05	21.28	161	11663	52896	34892211
COVID-19 pneumonia	183.35	21.28	97	11727	16870	34928237
Herpes zoster	153.68	21.28	112	11712	34287	34910820
Throat irritation	144.87	21.28	71	11753	10514	34934593

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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
COVID-19	5929.81	16.60	2310	32784	155364	79553930
Multiple sclerosis relapse	920.36	16.60	436	34658	46097	79663197
Infusion related reaction	751.62	16.60	696	34398	229541	79479753
Throat irritation	690.06	16.60	344	34750	40602	79668692
Urinary tract infection	637.79	16.60	690	34404	273822	79435472
Multiple sclerosis	599.62	16.60	259	34835	22023	79687271
SARS-CoV-2 test positive	429.80	16.60	170	34924	11546	79697748
COVID-19 pneumonia	426.55	16.60	222	34872	28627	79680667
Herpes zoster	371.65	16.60	316	34778	92767	79616527
Coronavirus infection	296.87	16.60	115	34979	7382	79701912

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FDA Adverse Event Reporting System (Pediatric)

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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
Perinatal stroke	26.42	20.71	4	10	11	89767

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Pharmacologic Action:

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Source	Code	Description
ATC	L04AA36	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Selective immunosuppressants
FDA CS	M0001357	Antibodies, Monoclonal
FDA CS	M0556300	Antibodies, Monoclonal, Humanized
FDA EPC	N0000175657	CD20-directed Cytolytic Antibody
FDA MoA	N0000175078	CD20-directed Antibody Interactions
MeSH PA	D007155	Immunologic Factors

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

Disease	Relation	SNOMED_ID	DOID
Primary progressive multiple sclerosis	indication	428700003	DOID:0050784

🐶 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	Kd	9.08		IUPHAR	DRUG LABEL

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External reference:

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ID	Source
017151	NDDF
1876366	RXNORM
254931	MMSL
32532	MMSL
4036552	VANDF
733464008	SNOMEDCT_US
7580	IUPHAR_LIGAND_ID
763559000	SNOMEDCT_US
8636	INN_ID
A10SJL62JY	UNII

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
OCREVUS	HUMAN PRESCRIPTION DRUG LABEL	1	50242-150	INJECTION	300 mg	INTRAVENOUS	BLA	29 sections
OCREVUS	HUMAN PRESCRIPTION DRUG LABEL	1	50242-150	INJECTION	300 mg	INTRAVENOUS	BLA	29 sections
OCREVUS	HUMAN PRESCRIPTION DRUG LABEL	1	50242-150	INJECTION	300 mg	INTRAVENOUS	BLA	29 sections

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