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:

Date	Agency	Company
July 13, 2011	EMA	Glaxo Group Ltd.
March 9, 2011	FDA	HUMAN GENOME SCIENCES INC.
Sept. 27, 2017	PMDA	GlaxoSmithKline KK

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
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
Proteinuria	75.05	16.61	48	13306	19097	63456571
Systemic lupus erythematosus rash	74.65	16.61	25	13329	2227	63473441
Exposure during pregnancy	68.96	16.61	120	13234	155427	63320241
Accidental exposure to product	66.03	16.61	51	13303	27354	63448314
Coombs positive haemolytic anaemia	63.97	16.61	15	13339	356	63475312
Leukopenia	62.30	16.61	79	13275	77211	63398457
Antinuclear antibody negative	59.55	16.61	13	13341	221	63475447
Pleuritic pain	58.03	16.61	30	13324	7999	63467669
Product availability issue	56.59	16.61	24	13330	4097	63471571
Circumstance or information capable of leading to medication error	54.68	16.61	23	13331	3847	63471821
Social problem	51.84	16.61	15	13339	823	63474845
Lupus pneumonitis	49.70	16.61	9	13345	54	63475614
Central nervous system lupus	49.38	16.61	13	13341	501	63475167
Rhesus antigen positive	48.75	16.61	10	13344	124	63475544
Antiphospholipid syndrome	48.16	16.61	17	13337	1773	63473895
Surgery	46.53	16.61	47	13307	35865	63439803
Renal vascular thrombosis	44.47	16.61	8	13346	46	63475622
Herpes simplex reactivation	43.44	16.61	12	13342	556	63475112
Urinary tract infection	43.20	16.61	138	13216	264546	63211122
Hospitalisation	42.11	16.61	69	13285	85012	63390656
Cutaneous lupus erythematosus	41.29	16.61	17	13337	2695	63472973
Malaise	36.95	16.61	179	13175	415775	63059893
Vasculitis	35.61	16.61	30	13324	18179	63457489
Gastritis haemorrhagic	35.29	16.61	13	13341	1532	63474136
Contraindicated product administered	34.67	16.61	3	13351	217645	63258023
Pyrexia	34.54	16.61	192	13162	470286	63005382
Parotid gland enlargement	34.40	16.61	11	13343	847	63474821
Drug interaction	34.31	16.61	4	13350	229127	63246541
Toxicity to various agents	33.13	16.61	6	13348	247244	63228424
Chills	31.49	16.61	72	13282	113306	63362362
Abortion spontaneous	31.48	16.61	44	13310	47151	63428517
Headache	31.44	16.61	234	13120	633007	62842661
Herpes zoster	30.64	16.61	59	13295	82403	63393265
Complex regional pain syndrome	29.97	16.61	13	13341	2344	63473324
Blood albumin increased	29.14	16.61	10	13344	959	63474709
Blood immunoglobulin M decreased	28.95	16.61	10	13344	978	63474690
Hyperparathyroidism secondary	28.62	16.61	11	13343	1456	63474212
Serositis	28.18	16.61	9	13345	690	63474978
Confusional state	27.17	16.61	8	13346	236372	63239296
Underdose	26.89	16.61	31	13323	27425	63448243
Immunoglobulins decreased	26.33	16.61	10	13344	1282	63474386
Blood immunoglobulin G decreased	26.26	16.61	12	13342	2446	63473222
Triple negative breast cancer	25.52	16.61	6	13348	144	63475524
Drug intolerance	25.23	16.61	17	13337	308644	63167024
Ophthalmic herpes zoster	24.95	16.61	11	13343	2062	63473606
Arthralgia	24.10	16.61	203	13151	569507	62906161
Complement factor decreased	24.08	16.61	5	13349	66	63475602
Lymphopenia	23.76	16.61	24	13330	18303	63457365
Haemorrhagic cyst	23.75	16.61	6	13348	196	63475472
Herpes zoster meningitis	23.43	16.61	5	13349	76	63475592
Anxiety disorder	23.29	16.61	13	13341	4037	63471631
Injection site rash	23.24	16.61	24	13330	18785	63456883
Skin disorder	21.94	16.61	29	13325	29478	63446190
Illness	21.89	16.61	38	13316	49021	63426647
Disseminated varicella zoster virus infection	21.87	16.61	6	13348	271	63475397
Cytomegalovirus enteritis	21.57	16.61	6	13348	285	63475383
Type 1 diabetes mellitus	21.34	16.61	12	13342	3778	63471890
Inappropriate schedule of product administration	20.49	16.61	58	13296	103907	63371761
Depression	19.92	16.61	88	13266	196404	63279264
Pneumocystis jirovecii pneumonia	19.85	16.61	21	13333	16893	63458775
Erysipelas	19.66	16.61	15	13339	7890	63467778
Osteonecrosis	19.63	16.61	25	13329	24505	63451163
General physical health deterioration	19.46	16.61	9	13345	201393	63274275
Female reproductive tract disorder	19.26	16.61	6	13348	424	63475244
Heat stroke	18.87	16.61	7	13347	841	63474827
Mean cell haemoglobin increased	18.44	16.61	10	13344	2933	63472735
Protein urine present	18.35	16.61	13	13341	6107	63469561
Intentional dose omission	17.24	16.61	14	13340	8061	63467607
Acute kidney injury	17.22	16.61	18	13336	263397	63212271
Acarodermatitis	17.21	16.61	7	13347	1076	63474592
Nephrotic syndrome	17.08	16.61	12	13342	5564	63470104
Influenza	17.06	16.61	56	13298	108666	63367002
Appendicitis	17.00	16.61	14	13340	8215	63467453
Pneumonia	16.82	16.61	158	13196	456609	63019059

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

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
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
Proteinuria	59.01	17.71	42	10253	32460	79701633
Rhesus antigen positive	53.62	17.71	10	10285	124	79733969
Product availability issue	50.28	17.71	19	10276	3928	79730165
Progressive multifocal leukoencephalopathy	45.39	17.71	30	10265	20570	79713523
Urinary tract infection	42.55	17.71	103	10192	274409	79459684
Herpes zoster	40.76	17.71	55	10240	93028	79641065
Renal vascular thrombosis	38.91	17.71	7	10288	70	79734023
Social problem	38.22	17.71	12	10283	1426	79732667
Headache	38.16	17.71	176	10119	653596	79080497
Abortion spontaneous	37.84	17.71	31	10264	29476	79704617
Circumstance or information capable of leading to medication error	36.25	17.71	15	10280	3933	79730160
Toxicity to various agents	35.31	17.71	6	10289	421534	79312559
Surgery	35.01	17.71	31	10264	32735	79701358
Drug interaction	34.57	17.71	6	10289	415177	79318916
Hospitalisation	31.50	17.71	49	10246	94187	79639906
Systemic lupus erythematosus	31.15	17.71	56	10239	121093	79613000
Blood immunoglobulin M decreased	30.98	17.71	10	10285	1299	79732794
Pleuritic pain	30.48	17.71	18	10277	10134	79723959
Arthralgia	30.46	17.71	150	10145	571653	79162440
Blood albumin increased	29.67	17.71	10	10285	1485	79732608
Triple negative breast cancer	29.67	17.71	6	10289	116	79733977
Immunoglobulins decreased	29.26	17.71	10	10285	1550	79732543
Malaise	28.60	17.71	132	10163	489737	79244356
Blood immunoglobulin G decreased	28.11	17.71	12	10283	3397	79730696
Hyperparathyroidism secondary	27.48	17.71	11	10284	2649	79731444
Vasculitis	27.32	17.71	24	10271	25078	79709015
JC virus infection	26.62	17.71	12	10283	3869	79730224
Accidental exposure to product	26.45	17.71	26	10269	31296	79702797
Serositis	26.35	17.71	8	10287	850	79733243
Acute kidney injury	25.50	17.71	18	10277	519386	79214707
Lupus pneumonitis	25.39	17.71	5	10290	84	79734009
Leukopenia	25.16	17.71	50	10245	116463	79617630
T-lymphocyte count decreased	25.00	17.71	7	10288	560	79733533
Bulbar palsy	24.84	17.71	6	10289	268	79733825
Female reproductive tract disorder	24.40	17.71	6	10289	289	79733804
Haemorrhagic cyst	24.16	17.71	6	10289	301	79733792
Ophthalmic herpes zoster	23.98	17.71	10	10285	2674	79731419
Pneumonia	23.77	17.71	156	10139	660090	79074003
Influenza	23.76	17.71	52	10243	129554	79604539
Injection site rash	23.30	17.71	19	10276	17935	79716158
Cutaneous lupus erythematosus	22.89	17.71	10	10285	2993	79731100
Chills	22.55	17.71	58	10237	160176	79573917
Acarodermatitis	22.52	17.71	8	10287	1390	79732703
Pyrexia	22.42	17.71	157	10138	678552	79055541
Migraine	21.92	17.71	40	10255	87453	79646640
Confusional state	21.73	17.71	7	10288	317990	79416103
Herpes zoster meningitis	21.64	17.71	5	10290	184	79733909
Type 1 diabetes mellitus	20.07	17.71	12	10283	6907	79727186
Premature rupture of membranes	19.99	17.71	10	10285	4059	79730034
Underdose	19.97	17.71	23	10272	33128	79700965
Disseminated varicella zoster virus infection	19.86	17.71	6	10289	627	79733466
Mean cell haemoglobin increased	19.50	17.71	10	10285	4275	79729818
Insurance issue	19.43	17.71	11	10284	5722	79728371
Knee operation	19.20	17.71	11	10284	5855	79728238
Hysterectomy	18.51	17.71	11	10284	6261	79727832
Cytomegalovirus enteritis	18.38	17.71	6	10289	808	79733285
Hypnotherapy	18.03	17.71	3	10292	18	79734075
Parophthalmia	17.96	17.71	5	10290	392	79733701

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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

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:

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

External reference:

ID	Source
D03068	KEGG_DRUG
4030652	VUID
N0000182640	NUI
4030652	VANDF
CHEMBL1789843	ChEMBL_ID
C511911	MESH_SUPPLEMENTAL_RECORD_UI
6887	IUPHAR_LIGAND_ID
DB08879	DRUGBANK_ID
1092437	RXNORM
180467	MMSL
27798	MMSL
d07756	MMSL
013666	NDDF
449043000	SNOMEDCT_US
704193005	SNOMEDCT_US
C1723401	UMLSCUI
8381	INN_ID
73B0K5S26A	UNII

Pharmaceutical products:

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