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

Stem definition	Drug id	CAS RN
human origin	4949	356547-88-1

Description:

Molecule	Description
Synonyms: belimumab benlysta LymphoStat B LymphoStat-B	monoclonal antibody directed against human BLyS protein (B lymphocyte stimulator) for treatment of autoimmune diseases Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

belimumab
benlysta
LymphoStat B
LymphoStat-B

monoclonal antibody directed against human BLyS protein (B lymphocyte stimulator) for treatment of autoimmune diseases

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

Drug dosage:

Dose	Unit	Route
25	mg	P

ADMET properties:

None

Approvals:

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Date	Agency	Company
July 13, 2011	EMA	Glaxo Group Ltd.
March 9, 2011	FDA	HUMAN GENOME SCIENCES INC.
Sept. 27, 2017	PMDA	GlaxoSmithKline 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
Lupus nephritis	312.64	16.61	80	13274	2759	63472909
Therapy interrupted	269.37	16.61	133	13221	32322	63443346
Product dose omission issue	262.99	16.61	283	13071	234030	63241638
Product complaint	194.19	16.61	80	13274	12729	63462939
Exposure via skin contact	187.87	16.61	37	13317	368	63475300
Wrong technique in device usage process	160.38	16.61	50	13304	3548	63472120
SLE arthritis	141.27	16.61	32	13322	649	63475019
Therapy cessation	138.81	16.61	84	13270	30373	63445295
COVID-19	93.49	16.61	117	13237	112986	63362682
Product storage error	77.94	16.61	45	13309	14911	63460757

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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
Progressive multifocal leukoencephalopathy	63.85	37.88	18	681	9746	34946486
T-lymphocyte count decreased	44.87	37.88	7	692	206	34956026

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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
Lupus nephritis	248.03	17.71	61	10234	2947	79731146
Therapy interrupted	248.00	17.71	107	10188	31234	79702859
Product dose omission issue	198.28	17.71	199	10096	247338	79486755
Therapy cessation	108.74	17.71	65	10230	37497	79696596
Exposure via skin contact	84.92	17.71	17	10278	312	79733781
COVID-19	83.07	17.71	102	10193	157572	79576521
Wrong technique in device usage process	68.51	17.71	24	10271	4004	79730089
Product complaint	63.26	17.71	32	10263	13317	79720776
Exposure during pregnancy	62.45	17.71	71	10224	101061	79633032
Product storage error	60.12	17.71	33	10262	16193	79717900

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	L04AA26	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Selective immunosuppressants
FDA EPC	N0000182637	B Lymphocyte Stimulator-specific Inhibitor
FDA MoA	N0000182636	B Lymphocyte Stimulator-directed Antibody Interactions
FDA PE	N0000182156	Decreased B Lymphocyte Activation
MeSH PA	D007155	Immunologic Factors
MeSH PA	D007166	Immunosuppressive Agents

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

Disease	Relation	SNOMED_ID	DOID
Systemic lupus erythematosus	indication	55464009	DOID:9074

🐶 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
Tumor necrosis factor ligand superfamily member 13B	Cytokine	Q9Y275	TN13B_HUMAN	ANTIBODY BINDING				DRUG LABEL	DRUG LABEL

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External reference:

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ID	Source
013666	NDDF
1092437	RXNORM
180467	MMSL
27798	MMSL
4030652	VUID
4030652	VANDF
449043000	SNOMEDCT_US
6887	IUPHAR_LIGAND_ID
704193005	SNOMEDCT_US
73B0K5S26A	UNII

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
BENLYSTA	HUMAN PRESCRIPTION DRUG LABEL	1	49401-088	SOLUTION	200 mg	SUBCUTANEOUS	BLA	30 sections
BENLYSTA	HUMAN PRESCRIPTION DRUG LABEL	1	49401-088	SOLUTION	200 mg	SUBCUTANEOUS	BLA	30 sections
BENLYSTA	HUMAN PRESCRIPTION DRUG LABEL	1	49401-088	SOLUTION	200 mg	SUBCUTANEOUS	BLA	30 sections
BENLYSTA	HUMAN PRESCRIPTION DRUG LABEL	1	49401-101	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	120 mg	INTRAVENOUS	BLA	30 sections
BENLYSTA	HUMAN PRESCRIPTION DRUG LABEL	1	49401-101	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	120 mg	INTRAVENOUS	BLA	30 sections
BENLYSTA	HUMAN PRESCRIPTION DRUG LABEL	1	49401-101	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	120 mg	INTRAVENOUS	BLA	30 sections
BENLYSTA	HUMAN PRESCRIPTION DRUG LABEL	1	49401-102	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	400 mg	INTRAVENOUS	BLA	30 sections
BENLYSTA	HUMAN PRESCRIPTION DRUG LABEL	1	49401-102	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	400 mg	INTRAVENOUS	BLA	30 sections
BENLYSTA	HUMAN PRESCRIPTION DRUG LABEL	1	49401-102	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	400 mg	INTRAVENOUS	BLA	30 sections

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