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:

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Date	Agency	Company
July 13, 2017	FDA	JANSSEN BIOTECH
March 23, 2018	PMDA	Janssen Pharmaceutical KK
Nov. 10, 2017	EMA	Janssen-Cilag International N.V.

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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
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

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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
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

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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
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

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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

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

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

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

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External reference:

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ID	Source
017278	NDDF
089658A12D	UNII
1928588	RXNORM
259984	MMSL
32911	MMSL
4036845	VANDF
736494008	SNOMEDCT_US
763578000	SNOMEDCT_US
7998	IUPHAR_LIGAND_ID
9774	INN_ID

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Pharmaceutical products:

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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

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