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

Stem definition	Drug id	CAS RN
chimeric origin	4974	170277-31-3

Description:

Molecule	Description
Synonyms: INFLIXIMAB-QBTX inflectra infliximab remicade infliximab-dyyb	Infliximab products neutralize the biological activity of TNF-alpha by binding with high affinity to the soluble and transmembrane forms of TNF-alpha and inhibit binding of TNF-alpha with its receptors. Infliximab products do not neutralize TNF-beta (lymphotoxin-alpha), a related cytokine that utilizes the same receptors as TNF-alpha. Biological activities attributed to TNF-alpha include: induction of pro-inflammatory cytokines such as interleukins (IL) 1 and 6, enhancement of leukocyte migration by increasing endothelial layer permeability and expression of adhesion molecules by endothelial cells and leukocytes, activation of neutrophil and eosinophil functional activity, induction of acute phase reactants and other liver proteins, as well as tissue degrading enzymes produced by synoviocytes and/or chondrocytes. Cells expressing transmembrane TNF-alpha bound by infliximab products can be lysed in vitro or in vivo. Infliximab products inhibit the functional activity of TNF-alpha in a wide variety of in vitro bioassays utilizing human fibroblasts, endothelial cells, neutrophils, B and T-lymphocytes and epithelial cells. The relationship of these biological response markers to the mechanism(s) by which infliximab products exert their clinical effects is unknown. Anti-TNF-alpha antibodies reduce disease activity in the cotton-top tamarin colitis model, and decrease synovitis and joint erosions in a murine model of collagen-induced arthritis. Infliximab products prevent disease in transgenic mice that develop polyarthritis as a result of constitutive expression of human TNF-alpha, and when administered after disease onset, allow eroded joints to heal. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

INFLIXIMAB-QBTX
inflectra
infliximab
remicade
infliximab-dyyb

Infliximab products neutralize the biological activity of TNF-alpha by binding with high affinity to the soluble and transmembrane forms of TNF-alpha and inhibit binding of TNF-alpha with its receptors. Infliximab products do not neutralize TNF-beta (lymphotoxin-alpha), a related cytokine that utilizes the same receptors as TNF-alpha. Biological activities attributed to TNF-alpha include: induction of pro-inflammatory cytokines such as interleukins (IL) 1 and 6, enhancement of leukocyte migration by increasing endothelial layer permeability and expression of adhesion molecules by endothelial cells and leukocytes, activation of neutrophil and eosinophil functional activity, induction of acute phase reactants and other liver proteins, as well as tissue degrading enzymes produced by synoviocytes and/or chondrocytes. Cells expressing transmembrane TNF-alpha bound by infliximab products can be lysed in vitro or in vivo. Infliximab products inhibit the functional activity of TNF-alpha in a wide variety of in vitro bioassays utilizing human fibroblasts, endothelial cells, neutrophils, B and T-lymphocytes and epithelial cells. The relationship of these biological response markers to the mechanism(s) by which infliximab products exert their clinical effects is unknown. Anti-TNF-alpha antibodies reduce disease activity in the cotton-top tamarin colitis model, and decrease synovitis and joint erosions in a murine model of collagen-induced arthritis. Infliximab products prevent disease in transgenic mice that develop polyarthritis as a result of constitutive expression of human TNF-alpha, and when administered after disease onset, allow eroded joints to heal.

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

Drug dosage:

Dose	Unit	Route
3.75	mg	P

ADMET properties:

None

Approvals:

Date	Agency	Company
Aug. 13, 1999	EMA
Aug. 24, 1998	FDA	CENTOCOR INC
Jan. 17, 2002	PMDA	Tanabe Seiyaku

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
Infusion related reaction	5425.41	11.99	8106	496605	237415	62746896
Off label use	4304.54	11.99	13404	491307	661058	62323253
Intentional product use issue	3239.09	11.99	4511	500200	123381	62860930
Product use issue	3191.95	11.99	6031	498680	214489	62769822
Drug ineffective	2875.05	11.99	16028	488683	1028737	61955574
Condition aggravated	2488.99	11.99	7926	496785	394291	62590020
Systemic lupus erythematosus	2238.27	11.99	5050	499661	203868	62780443
Contraindicated product administered	2144.83	11.99	5091	499620	212557	62771754
Inappropriate schedule of product administration	1907.25	11.99	3158	501553	100807	62883504
Drug intolerance	1883.74	11.99	6058	498653	302603	62681708

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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
Off label use	5859.70	12.22	9223	186628	410301	34350779
Intentional product use issue	4802.19	12.22	3385	192466	56431	34704649
Infusion related reaction	4211.83	12.22	2983	192868	50074	34711006
Inappropriate schedule of product administration	3382.16	12.22	2794	193057	59502	34701578
Product use issue	3166.89	12.22	2707	193144	60509	34700571
Condition aggravated	2529.54	12.22	4135	191716	188061	34573019
Blood pressure fluctuation	1717.31	12.22	1295	194556	23954	34737126
Drug ineffective	1344.79	12.22	5570	190281	451181	34309899
Weight increased	1158.59	12.22	1957	193894	91076	34670004
Drug level below therapeutic	1110.57	12.22	569	195282	5046	34756034

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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
Off label use	10470.80	11.54	20331	514635	886884	78322538
Intentional product use issue	8445.74	11.54	7463	527503	144649	79064773
Infusion related reaction	6024.94	11.54	7560	527406	222677	78986745
Inappropriate schedule of product administration	6023.84	11.54	5840	529126	127788	79081634
Product use issue	5517.28	11.54	6908	528058	202914	79006508
Condition aggravated	5165.39	11.54	10755	524211	490369	78719053
Drug ineffective	2786.71	11.54	14411	520555	1066502	78142920
Toxicity to various agents	2441.59	11.54	88	534878	421452	78787970
Blood pressure fluctuation	2417.94	11.54	2603	532363	64542	79144880
Acute kidney injury	2260.36	11.54	385	534581	519019	78690403

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	L04AB02	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	D003879	Dermatologic Agents
MeSH PA	D005765	Gastrointestinal 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
Ulcerative colitis	indication	64766004	DOID:8577
Rheumatoid arthritis	indication	69896004	DOID:7148
Plaque psoriasis	indication	200965009
Pustular psoriasis	indication	200973000
Erythrodermic psoriasis	indication	200977004
Behcet's disease	indication	310701003	DOID:13241
Adenosine deaminase deficiency 2	off-label use	987840791000119102

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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				UNKNOWN	DRUG LABEL

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External reference:

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ID	Source
007640	NDDF
016773	NDDF
017837	NDDF
108675009	SNOMEDCT_US
11846	MMSL
1790539	RXNORM
230325	MMSL
33395	MMSL
33397	MMSL
353325	MMSL

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
AVSOLA	HUMAN PRESCRIPTION DRUG LABEL	1	55513-670	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	BLA	33 sections
AVSOLA	HUMAN PRESCRIPTION DRUG LABEL	1	55513-670	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	BLA	33 sections
AVSOLA	HUMAN PRESCRIPTION DRUG LABEL	1	55513-670	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	BLA	33 sections
INFLECTRA	HUMAN PRESCRIPTION DRUG LABEL	1	0069-0809	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	BLA	33 sections
INFLECTRA	HUMAN PRESCRIPTION DRUG LABEL	1	0069-0809	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	BLA	33 sections
INFLECTRA	HUMAN PRESCRIPTION DRUG LABEL	1	0069-0809	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	BLA	33 sections
INFLIXIMAB	HUMAN PRESCRIPTION DRUG LABEL	1	57894-160	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	BLA	32 sections
REMICADE	HUMAN PRESCRIPTION DRUG LABEL	1	57894-030	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	BLA	31 sections
REMICADE	HUMAN PRESCRIPTION DRUG LABEL	1	57894-030	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	BLA	31 sections
Renflexis	HUMAN PRESCRIPTION DRUG LABEL	1	0006-4305	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	BLA	29 sections

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