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

Stem definition	Drug id	CAS RN
human origin	5246	1350289-85-8

Description:

Molecule	Description
Synonyms: guselkumab CNTO 1959 tremfya	Guselkumab is a human monoclonal IgG1-lambda antibody that selectively binds to the p19 subunit of interleukin 23 (IL-23) and inhibits its interaction with the IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Guselkumab inhibits the release of proinflammatory cytokines and chemokines. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

guselkumab
CNTO 1959
tremfya

Guselkumab is a human monoclonal IgG1-lambda antibody that selectively binds to the p19 subunit of interleukin 23 (IL-23) and inhibits its interaction with the IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Guselkumab inhibits the release of proinflammatory cytokines and chemokines.

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

Drug dosage:

Dose	Unit	Route
1.79	mg	P

ADMET properties:

None

Approvals:

Date	Agency	Company
Nov. 10, 2017	EMA	Janssen-Cilag International N.V.
July 13, 2017	FDA	JANSSEN BIOTECH
March 23, 2018	PMDA	Janssen Pharmaceutical 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
Product dose omission issue	4189.92	31.55	1459	7674	232854	63247035
Accidental exposure to product	1289.82	31.55	363	8770	27042	63452847
Device malfunction	863.75	31.55	242	8891	17615	63462274
Needle issue	807.89	31.55	205	8928	10171	63469718
Drug delivery system malfunction	665.80	31.55	119	9014	1021	63478868
Device issue	554.46	31.55	184	8949	23597	63456292
Product leakage	499.02	31.55	89	9044	752	63479137
Device leakage	346.28	31.55	97	9036	6999	63472890
Drug ineffective	264.44	31.55	505	8628	1044260	62435629
Product storage error	241.14	31.55	88	9045	14868	63465021
Device defective	235.43	31.55	55	9078	1907	63477982
Underdose	230.86	31.55	101	9032	27355	63452534
Syringe issue	224.49	31.55	57	9076	2812	63477077
Inappropriate schedule of product administration	202.57	31.55	146	8987	103819	63376070
COVID-19	189.36	31.55	145	8988	112958	63366931
Psoriasis	129.24	31.55	104	9029	86853	63393036
Product quality issue	95.01	31.55	61	9072	35804	63444085
Liquid product physical issue	90.07	31.55	23	9110	1159	63478730
Therapy interrupted	83	31.55	54	9079	32401	63447488
Psoriatic arthropathy	72.39	31.55	77	9056	91443	63388446
Injection site haemorrhage	56.21	31.55	38	9095	24276	63455613
Product packaging issue	43.30	31.55	13	9120	1193	63478696
Therapy cessation	40.10	31.55	34	9099	30423	63449466
Product complaint	39.48	31.55	24	9109	12785	63467104
Injection site reaction	37.25	31.55	44	9089	58480	63421409
Paternal exposure during pregnancy	35.00	31.55	7	9126	114	63479775

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
Product dose omission issue	3484.93	37.27	1132	5128	118579	34832092
Accidental exposure to product	771.84	37.27	216	6044	12586	34938085
Needle issue	589.64	37.27	150	6110	6015	34944656
Device malfunction	494.06	37.27	146	6114	10275	34940396
Drug delivery system malfunction	407.78	37.27	69	6191	318	34950353
Device issue	394.41	37.27	121	6139	9656	34941015
Product leakage	304.90	37.27	57	6203	503	34950168
Inappropriate schedule of product administration	255.14	37.27	151	6109	62145	34888526
Drug ineffective	233.15	37.27	341	5919	456410	34494261
Product storage error	226.56	37.27	76	6184	8046	34942625
Device leakage	197.22	37.27	65	6195	6510	34944161
Underdose	180.54	37.27	74	6186	13706	34936965
Syringe issue	126.83	37.27	45	6215	5619	34945052
Device defective	115.82	37.27	27	6233	739	34949932
COVID-19	72.57	37.27	79	6181	77471	34873200
Liquid product physical issue	72.23	37.27	17	6243	485	34950186
Psoriasis	72.22	37.27	58	6202	38754	34911917
Product quality issue	71.31	37.27	42	6218	16993	34933678
Psoriatic arthropathy	70.49	37.27	44	6216	19754	34930917
Therapy interrupted	60.57	37.27	35	6225	13662	34937009
Injection site haemorrhage	54.24	37.27	29	6231	9739	34940932
Arthralgia	50.95	37.27	101	6159	169940	34780731
Product use issue	46.62	37.27	57	6203	63159	34887512
Therapeutic product effect decreased	46.46	37.27	43	6217	34700	34915971
Therapy cessation	46.44	37.27	32	6228	16941	34933730
Angioimmunoblastic T-cell lymphoma	41.11	37.27	10	6250	329	34950342
Product packaging issue	39.09	37.27	11	6249	643	34950028

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
Product dose omission issue	5640.52	28.28	1831	9223	245706	79487628
Accidental exposure to product	1581.92	28.28	435	10619	30887	79702447
Needle issue	1066.17	28.28	266	10788	12802	79720532
Drug delivery system malfunction	912.44	28.28	145	10909	572	79732762
Device malfunction	801.77	28.28	236	10818	21212	79712122
Device issue	685.34	28.28	221	10833	26887	79706447
Product leakage	635.17	28.28	111	10943	859	79732475
Device leakage	398.84	28.28	118	10936	10738	79722596
Product storage error	396.33	28.28	129	10925	16097	79717237
Inappropriate schedule of product administration	310.35	28.28	206	10848	133422	79599912
Underdose	289.85	28.28	124	10930	33027	79700307
Syringe issue	255.67	28.28	74	10980	6224	79727110
COVID-19	233.20	28.28	185	10869	157489	79575845
Device defective	196.54	28.28	47	11007	1873	79731461
Psoriasis	169.72	28.28	122	10932	89465	79643869
Therapy interrupted	137.53	28.28	73	10981	31268	79702066
Product quality issue	134.83	28.28	74	10980	33866	79699468
Liquid product physical issue	121.51	28.28	29	11025	1145	79732189
Drug ineffective	106.55	28.28	359	10695	1080554	78652780
Psoriatic arthropathy	101.33	28.28	85	10969	77914	79655420
Injection site haemorrhage	100.41	28.28	57	10997	27813	79705521
Product packaging issue	66.01	28.28	18	11036	1215	79732119
Therapy cessation	63.91	28.28	48	11006	37514	79695820
Product complaint	55.46	28.28	30	11024	13319	79720015
Hypotension	49.15	28.28	3	11051	440314	79293020
Product use issue	46.73	28.28	95	10959	209727	79523607
Toxicity to various agents	43.84	28.28	4	11050	421536	79311798
Anaemia	41.85	28.28	6	11048	445009	79288325
Angioimmunoblastic T-cell lymphoma	40.53	28.28	10	11044	454	79732880
Injection site pain	39.17	28.28	67	10987	129771	79603563
Acute kidney injury	36.91	28.28	13	11041	519391	79213943
Drug delivery system issue	36.59	28.28	7	11047	93	79733241
Wrong technique in product usage process	33.40	28.28	46	11008	73829	79659505
Wrong schedule	32.47	28.28	8	11046	361	79732973
Off label use	32.10	28.28	225	10829	906990	78826344
Product dispensing error	32.00	28.28	21	11033	13242	79720092
Arthralgia	29.85	28.28	157	10897	571646	79161688
Poor quality product administered	29.73	28.28	13	11041	3632	79729702
Illness	29.01	28.28	34	11020	46477	79686857
Physical product label issue	28.91	28.28	5	11049	36	79733298
Asthenia	28.37	28.28	18	11036	511671	79221663

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L04AC16	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Interleukin inhibitors
FDA MoA	N0000192798	Interleukin-23 Antagonists
FDA EPC	N0000192799	Interleukin-23 Antagonist

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

Disease	Relation	SNOMED_ID	DOID
Palmoplantar pustulosis	indication	27520001	DOID:4398
Plaque psoriasis	indication	200965009

🐶 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
Interleukin-23	Cytokine	P29460 Q9NPF7	IL12B_HUMAN IL23A_HUMAN	ANTIBODY BINDING				UNKNOWN	DRUG LABEL

External reference:

ID	Source
089658A12D	UNII
4036845	VANDF
C3852217	UMLSCUI
CHEMBL2364648	ChEMBL_ID
DB11834	DRUGBANK_ID
D10438	KEGG_DRUG
9774	INN_ID
7998	IUPHAR_LIGAND_ID
259984	MMSL
32911	MMSL
d08615	MMSL
017278	NDDF
736494008	SNOMEDCT_US
763578000	SNOMEDCT_US
1928588	RXNORM
C000588857	MESH_SUPPLEMENTAL_RECORD_UI

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Tremfya	HUMAN PRESCRIPTION DRUG LABEL	1	57894-640	INJECTION	100 mg	SUBCUTANEOUS	BLA	32 sections
Tremfya	HUMAN PRESCRIPTION DRUG LABEL	1	57894-640	INJECTION	100 mg	SUBCUTANEOUS	BLA	32 sections
Tremfya	HUMAN PRESCRIPTION DRUG LABEL	1	57894-640	INJECTION	100 mg	SUBCUTANEOUS	BLA	32 sections