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

Stem definition	Drug id	CAS RN
humanized origin	4968	428863-50-7

Description:

Molecule	Description
Synonyms: certolizumab pegol cimzia certolizumab	A polyethylene-glycolated Fab' fragment of TUMOR NECROSIS FACTOR antibody that binds specifically to TNF-ALPHA and neutralises it in a dose-dependent manner. It also inhibits the production of lipopolysaccharide-induced TNF-ALPHA and IL-1 BETA and is used to treat RHEUMATOID ARTHRITIS and PSORIATIC ARTHRITIS. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

certolizumab pegol
cimzia
certolizumab

A polyethylene-glycolated Fab' fragment of TUMOR NECROSIS FACTOR antibody that binds specifically to TNF-ALPHA and neutralises it in a dose-dependent manner. It also inhibits the production of lipopolysaccharide-induced TNF-ALPHA and IL-1 BETA and is used to treat RHEUMATOID ARTHRITIS and PSORIATIC ARTHRITIS.

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

Drug dosage:

Dose	Unit	Route
14	mg	P

ADMET properties:

None

Approvals:

Date	Agency	Company
April 22, 2008	FDA	UCB INC
Dec. 25, 2012	PMDA	UCB Japan Co., Ltd.
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
Drug ineffective	3656.04	19.04	12031	290146	1032734	62154111
Pemphigus	3468.64	19.04	4316	297861	179410	63007435
Systemic lupus erythematosus	3195.21	19.04	4425	297752	204493	62982352
Contraindicated product administered	3137.45	19.04	4481	297696	213167	62973678
Glossodynia	2923.70	19.04	3914	298263	174962	63011883
Hand deformity	2461.68	19.04	3395	298782	156062	63030783
Maternal exposure during pregnancy	2431.34	19.04	4007	298170	216055	62970790
Alopecia	2393.84	19.04	5079	297098	332457	62854388
Swelling	2322.81	19.04	4455	297722	270923	62915922
Abdominal discomfort	2229.12	19.04	4789	297388	316096	62870749

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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	1323.50	19.53	1772	28280	454979	34471900
Synovitis	581.78	19.53	270	29782	13796	34913083
Treatment failure	413.09	19.53	333	29719	46364	34880515
No adverse event	362.96	19.53	233	29819	22694	34904185
Joint swelling	332.12	19.53	328	29724	59562	34867317
Maternal exposure before pregnancy	302.20	19.53	80	29972	711	34926168
Rheumatoid arthritis	301.10	19.53	255	29797	37983	34888896
Therapeutic product effect decreased	294.92	19.53	242	29810	34501	34892378
Loss of personal independence in daily activities	273.03	19.53	227	29825	32952	34893927
Maternal exposure during pregnancy	269.30	19.53	115	29937	4803	34922076

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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
Drug ineffective	2791.57	20.07	7693	205195	1073220	78458280
Synovitis	2738.38	20.07	2639	210249	148095	79383405
Contraindicated product administered	2662.04	20.07	2651	210237	154887	79376613
Pemphigus	2429.32	20.07	2059	210829	97523	79433977
Drug intolerance	2381.41	20.07	3214	209674	260905	79270595
Hand deformity	2326.89	20.07	2046	210842	101873	79429627
Systemic lupus erythematosus	2280.64	20.07	2164	210724	118985	79412515
Joint swelling	2198.26	20.07	3240	209648	285406	79246094
Glossodynia	2134.22	20.07	1944	210944	101393	79430107
Anti-cyclic citrullinated peptide antibody positive	2088.91	20.07	1749	211139	81394	79450106

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	L04AB05	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	D018501	Antirheumatic 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
Crohn's disease	indication	34000006
Rheumatoid arthritis	indication	69896004	DOID:7148
Psoriatic arthritis	indication	156370009	DOID:9008
Plaque psoriasis	indication	200965009
Pustular psoriasis	indication	200973000
Erythrodermic psoriasis	indication	200977004

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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	Kd	10.05		DRUG LABEL	DRUG LABEL

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External reference:

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ID	Source
012650	NDDF
136438	MMSL
25282	MMSL
4027433	VANDF
4028807	VUID
4028807	VANDF
430306004	SNOMEDCT_US
430307008	SNOMEDCT_US
6774	IUPHAR_LIGAND_ID
709271	RXNORM

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Cimzia	HUMAN PRESCRIPTION DRUG LABEL	1	50474-710	INJECTION, SOLUTION	200 mg	SUBCUTANEOUS	BLA	33 sections
Cimzia	HUMAN PRESCRIPTION DRUG LABEL	1	50474-710	INJECTION, SOLUTION	200 mg	SUBCUTANEOUS	BLA	33 sections

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