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

Stem definition	Drug id	CAS RN
human origin	4967	476181-74-5

Description:

Molecule	Description
Synonyms: golimumab simponi CNTO 148 CNTO-148	Golimumab plus MTX effectively reduces the signs and symptoms of RA and is generally well tolerated in patients with an inadequate response to MTX. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

golimumab
simponi
CNTO 148
CNTO-148

Golimumab plus MTX effectively reduces the signs and symptoms of RA and is generally well tolerated in patients with an inadequate response to MTX.

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

Drug dosage:

Dose	Unit	Route
1.66	mg	P

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
April 24, 2009	FDA	CENTOCOR ORTHO BIOTECH INC
Oct. 1, 2009	EMA

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
Contraindicated product administered	3677.34	23.46	4679	278333	212969	62993041
Pemphigus	3354.89	23.46	4108	278904	179618	63026392
Glossodynia	3150.27	23.46	3928	279084	174948	63031062
Systemic lupus erythematosus	3011.61	23.46	4157	278855	204761	63001249
Drug ineffective	2701.03	23.46	10435	272577	1034330	62171680
Drug intolerance	2588.12	23.46	4795	278217	303866	62902144
Hand deformity	2582.36	23.46	3360	279652	156097	63049913
Joint swelling	2426.26	23.46	4829	278183	322837	62883173
Swelling	2417.54	23.46	4365	278647	271013	62934997
Therapeutic product effect decreased	2402.40	23.46	3585	279427	189602	63016408

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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
Drug ineffective	873.49	20.27	1411	26745	455340	34473435
Synovitis	480.68	20.27	232	27924	13834	34914941
Treatment failure	467.83	20.27	349	27807	46348	34882427
Rheumatoid arthritis	394.55	20.27	291	27865	37947	34890828
Therapeutic product effect decreased	364.25	20.27	267	27889	34476	34894299
Product dose omission issue	354.39	20.27	458	27698	119253	34809522
Psoriatic arthropathy	289.84	20.27	187	27969	19611	34909164
Product use issue	261.22	20.27	287	27869	62929	34865846
Ankylosing spondylitis	245.98	20.27	110	28046	5494	34923281
Enthesopathy	243.08	20.27	103	28053	4510	34924265

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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
Contraindicated product administered	2891.69	21.94	2803	215132	154735	79371718
Drug intolerance	2879.01	21.94	3571	214364	260548	79265905
Synovitis	2639.15	21.94	2614	215321	148120	79378333
Joint swelling	2513.15	21.94	3495	214440	285151	79241302
Therapeutic product effect decreased	2420.95	21.94	2594	215341	161269	79365184
Pemphigus	2344.59	21.94	2038	215897	97544	79428909
Drug ineffective	2275.80	21.94	7271	210664	1073642	78452811
Hand deformity	2198.55	21.94	2002	215933	101917	79424536
Systemic lupus erythematosus	2136.21	21.94	2110	215825	119039	79407414
Glossodynia	2044.83	21.94	1918	216017	101419	79425034

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	L04AB06	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Tumor necrosis factor alpha (TNF-alpha) inhibitors
FDA EPC	N0000175610	Tumor Necrosis Factor Blocker
FDA MoA	N0000175451	Tumor Necrosis Factor Receptor Blocking Activity
MeSH PA	D000893	Anti-Inflammatory Agents
MeSH PA	D007155	Immunologic Factors
MeSH PA	D007166	Immunosuppressive Agents
MeSH PA	D000079424	Tumor Necrosis Factor Inhibitors

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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
Ankylosing spondylitis	indication	9631008	DOID:7147
Psoriasis with arthropathy	indication	33339001
Ulcerative colitis	indication	64766004	DOID:8577
Rheumatoid arthritis	indication	69896004	DOID:7148
Juvenile idiopathic arthritis	indication	410502007
Nonradiographic axial spondyloarthritis	indication	713777005
Polyarticular juvenile idiopathic arthritis	indication	16044800000000000

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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
Tumor necrosis factor	Cytokine	P01375	TNFA_HUMAN	ANTIBODY BINDING				DRUG LABEL	DRUG LABEL

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External reference:

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ID	Source
013091	NDDF
164144	MMSL
164146	MMSL
26409	MMSL
4028717	VUID
4028717	VANDF
442318002	SNOMEDCT_US
442435002	SNOMEDCT_US
6776	IUPHAR_LIGAND_ID
819300	RXNORM

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Simponi	HUMAN PRESCRIPTION DRUG LABEL	1	57894-070	INJECTION, SOLUTION	50 mg	SUBCUTANEOUS	BLA	30 sections
Simponi	HUMAN PRESCRIPTION DRUG LABEL	1	57894-070	INJECTION, SOLUTION	50 mg	SUBCUTANEOUS	BLA	30 sections
Simponi	HUMAN PRESCRIPTION DRUG LABEL	1	57894-071	INJECTION, SOLUTION	100 mg	SUBCUTANEOUS	BLA	30 sections
Simponi	HUMAN PRESCRIPTION DRUG LABEL	1	57894-071	INJECTION, SOLUTION	100 mg	SUBCUTANEOUS	BLA	30 sections
SIMPONI ARIA	HUMAN PRESCRIPTION DRUG LABEL	1	57894-350	SOLUTION	50 mg	INTRAVENOUS	BLA	29 sections
SIMPONI ARIA	HUMAN PRESCRIPTION DRUG LABEL	1	57894-350	SOLUTION	50 mg	INTRAVENOUS	BLA	29 sections

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