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

Stem definition	Drug id	CAS RN
Tumour Necrosis Factor (TNF) receptors	4978	185243-69-0

Description:

Molecule	Description
Synonyms: etanercept-szzs erelzi etanercept enbrel TNR 001 TNR-001 etanercept (genetical recombination)	A recombinant version of soluble human TNF receptor fused to an IgG FC fragment that binds specifically to TUMOR NECROSIS FACTOR and inhibits its binding with endogenous TNF receptors. It prevents the inflammatory effect of TNF and is used to treat RHEUMATOID ARTHRITIS; PSORIATIC ARTHRITIS and ANKYLOSING SPONDYLITIS. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

etanercept-szzs
erelzi
etanercept
enbrel
TNR 001
TNR-001
etanercept (genetical recombination)

A recombinant version of soluble human TNF receptor fused to an IgG FC fragment that binds specifically to TUMOR NECROSIS FACTOR and inhibits its binding with endogenous TNF receptors. It prevents the inflammatory effect of TNF and is used to treat RHEUMATOID ARTHRITIS; PSORIATIC ARTHRITIS and ANKYLOSING SPONDYLITIS.

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

Drug dosage:

Dose	Unit	Route
7	mg	P

ADMET properties:

None

Approvals:

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Date	Agency	Company
Feb. 3, 2000	EMA
Jan. 19, 2005	PMDA	WYETH LEDERLE JAPAN, WYETH
Nov. 2, 1998	FDA	IMMUNEX

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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
Injection site erythema	40081.01	13.57	21479	980092	61695	62425756
Injection site pain	39179.79	13.57	24727	976844	105073	62382378
Injection site pruritus	22445.77	13.57	11919	989652	33197	62454254
Injection site swelling	21359.43	13.57	11741	989830	35831	62451620
Injection site reaction	16654.77	13.57	10768	990803	47756	62439695
Injection site bruising	13179.40	13.57	8217	993354	33693	62453758
Injection site warmth	11831.93	13.57	5451	996120	9744	62477707
Drug ineffective	9031.56	13.57	36285	965286	1008480	61478971
Injection site rash	6664.36	13.57	3983	997588	14826	62472625
Arthralgia	5975.37	13.57	21107	980464	548603	61938848

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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
Injection site pain	11175.94	13.86	5390	231768	33615	34686158
Injection site erythema	7222.46	13.86	3036	234122	12863	34706910
Arthralgia	4779.52	13.86	5808	231350	164233	34555540
Drug ineffective	4663.87	13.86	9787	227371	446964	34272809
Injection site swelling	4336.56	13.86	1928	235230	9599	34710174
Injection site pruritus	3877.00	13.86	1541	235617	5442	34714331
Injection site reaction	3132.12	13.86	1602	235556	11431	34708342
Therapeutic product effect decreased	2846.33	13.86	2150	235008	32593	34687180
Injection site bruising	2802.93	13.86	1305	235853	7358	34712415
Joint swelling	2711.78	13.86	2637	234521	57253	34662520

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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
Injection site pain	48976.75	13.87	26208	956708	103630	78657842
Injection site erythema	47604.30	13.87	21873	961043	56324	78705148
Injection site pruritus	26104.73	13.87	11961	970955	30322	78731150
Injection site swelling	25651.43	13.87	12219	970697	34913	78726559
Injection site reaction	18430.47	13.87	10279	972637	44506	78716966
Injection site bruising	16543.56	13.87	8681	974235	32321	78729151
Injection site warmth	13575.15	13.87	5543	977373	9264	78752208
Arthralgia	10406.11	13.87	22173	960743	549630	78211842
Drug ineffective	8781.94	13.87	31136	951780	1049777	77711695
Wrong technique in product usage process	8581.35	13.87	7182	975734	66693	78694779

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	L04AB01	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	D000700	Analgesics
MeSH PA	D018712	Analgesics, Non-Narcotic
MeSH PA	D000893	Anti-Inflammatory Agents
MeSH PA	D000894	Anti-Inflammatory Agents, Non-Steroidal
MeSH PA	D018501	Antirheumatic Agents
MeSH PA	D005765	Gastrointestinal Agents
MeSH PA	D007155	Immunologic Factors

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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
Rheumatoid arthritis	indication	69896004	DOID:7148
Plaque psoriasis	indication	200965009
Juvenile idiopathic arthritis	indication	410502007
Nonradiographic axial spondyloarthritis	indication	713777005
Sepsis	contraindication	91302008

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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	INHIBITOR				DRUG LABEL	DRUG LABEL

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External reference:

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ID	Source
007673	NDDF
016975	NDDF
118259007	SNOMEDCT_US
13915	MMSL
2103480	RXNORM
33391	MMSL
387045004	SNOMEDCT_US
4021136	VUID
4021136	VANDF
6789	IUPHAR_LIGAND_ID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
ENBREL	HUMAN PRESCRIPTION DRUG LABEL	1	50090-3531	SOLUTION	50 mg	SUBCUTANEOUS	BLA	32 sections
ENBREL	HUMAN PRESCRIPTION DRUG LABEL	1	50090-4490	SOLUTION	50 mg	SUBCUTANEOUS	BLA	29 sections
ENBREL	HUMAN PRESCRIPTION DRUG LABEL	1	50090-4590	SOLUTION	50 mg	SUBCUTANEOUS	BLA	32 sections
ENBREL	HUMAN PRESCRIPTION DRUG LABEL	1	58406-010	SOLUTION	25 mg	SUBCUTANEOUS	BLA	34 sections
ENBREL	HUMAN PRESCRIPTION DRUG LABEL	1	58406-010	SOLUTION	25 mg	SUBCUTANEOUS	BLA	34 sections
ENBREL	HUMAN PRESCRIPTION DRUG LABEL	1	58406-010	SOLUTION	25 mg	SUBCUTANEOUS	BLA	34 sections
ENBREL	HUMAN PRESCRIPTION DRUG LABEL	1	58406-010	SOLUTION	25 mg	SUBCUTANEOUS	BLA	34 sections
ENBREL	HUMAN PRESCRIPTION DRUG LABEL	1	58406-021	SOLUTION	50 mg	SUBCUTANEOUS	BLA	34 sections
ENBREL	HUMAN PRESCRIPTION DRUG LABEL	1	58406-021	SOLUTION	50 mg	SUBCUTANEOUS	BLA	34 sections
ENBREL	HUMAN PRESCRIPTION DRUG LABEL	1	58406-021	SOLUTION	50 mg	SUBCUTANEOUS	BLA	34 sections

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