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

Stem definition	Drug id	CAS RN
humanized origin	4970	189261-10-7

Description:

Molecule	Description
Synonyms: antegren natalizumab tysabri	A humanized monoclonal immunoglobulin G4 antibody to human INTEGRIN ALPHA4 that binds to the alpha4 subunit of INTEGRIN ALPHA4BETA1 and integrin alpha4beta7. It is used as an IMMUNOLOGIC FACTOR in the treatment of RELAPSING-REMITTING MULTIPLE SCLEROSIS and CROHN'S DISEASE. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

antegren
natalizumab
tysabri

A humanized monoclonal immunoglobulin G4 antibody to human INTEGRIN ALPHA4 that binds to the alpha4 subunit of INTEGRIN ALPHA4BETA1 and integrin alpha4beta7. It is used as an IMMUNOLOGIC FACTOR in the treatment of RELAPSING-REMITTING MULTIPLE SCLEROSIS and CROHN'S DISEASE.

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

Drug dosage:

Dose	Unit	Route
10	mg	P

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
June 27, 2006	EMA
Nov. 23, 2004	FDA	BIOGEN IDEC

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
Multiple sclerosis relapse	13035.57	13.26	4298	99392	44180	63341152
Progressive multifocal leukoencephalopathy	3818.38	13.26	1236	102454	11735	63373597
Immune reconstitution inflammatory syndrome	2592.38	13.26	770	102920	5314	63380018
General symptom	1795.36	13.26	488	103202	2320	63383012
Urinary tract infection	1752.05	13.26	2154	101536	262530	63122802
Opportunistic infection	1185.44	13.26	325	103365	1604	63383728
Malaise	1184.79	13.26	2290	101400	413664	62971668
Abortion spontaneous	1179.69	13.26	812	102878	46383	63338949
Drug specific antibody present	1139.85	13.26	378	103312	3881	63381451
Prescribed underdose	884.47	13.26	570	103120	29119	63356213

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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
Multiple sclerosis relapse	4680	16.19	1254	29033	11879	34914765
Progressive multifocal leukoencephalopathy	1902.97	16.19	584	29703	9180	34917464
Immune reconstitution inflammatory syndrome	962.19	16.19	340	29947	8419	34918225
Urinary tract infection	746.86	16.19	602	29685	83479	34843165
General symptom	679.87	16.19	157	30130	727	34925917
Opportunistic infection	443.91	16.19	127	30160	1531	34925113
Prescribed underdose	357.20	16.19	168	30119	8765	34917879
Drug specific antibody present	347.10	16.19	124	30163	3161	34923483
Malaise	329.86	16.19	582	29705	185243	34741401
Gait disturbance	329.86	16.19	387	29900	84753	34841891

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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
Multiple sclerosis relapse	13130.97	12.93	3995	93427	42538	79604428
Progressive multifocal leukoencephalopathy	5094.06	12.93	1603	95819	18997	79627969
Immune reconstitution inflammatory syndrome	3229.05	12.93	1031	96391	12810	79634156
Urinary tract infection	1973.58	12.93	2029	95393	272483	79374483
General symptom	1432.45	12.93	376	97046	2158	79644808
Abortion spontaneous	1055.01	12.93	575	96847	28932	79618034
Drug specific antibody present	994.57	12.93	355	97067	6297	79640669
Prescribed underdose	929.15	12.93	529	96893	28985	79617981
Malaise	773.64	12.93	1787	95635	488082	79158884
Fall	742.78	12.93	1754	95668	485875	79161091

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	L04AA23	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Selective immunosuppressants
FDA EPC	N0000175775	Integrin Receptor Antagonist
FDA MoA	N0000175774	Integrin Receptor Antagonists
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
Multiple sclerosis	indication	24700007	DOID:2377
Crohn's disease	indication	34000006
Progressive multifocal leukoencephalopathy	contraindication	22255007	DOID:643

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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
Integrin alpha-4/beta-1	Adhesion	P13612 P05556	ITA4_HUMAN ITB1_HUMAN	ANTIBODY BINDING				DRUG LABEL	DRUG LABEL
Integrin alpha-4/beta-7	Adhesion	P13612 P26010	ITA4_HUMAN ITB7_HUMAN	ANTIBODY BINDING				DRUG LABEL	DRUG LABEL

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External reference:

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ID	Source
008765	NDDF
19083	MMSL
354770	RXNORM
3JB47N2Q2P	UNII
4021508	VUID
4021508	VANDF
414804006	SNOMEDCT_US
414805007	SNOMEDCT_US
63826	MMSL
6591	IUPHAR_LIGAND_ID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
TYSABRI	HUMAN PRESCRIPTION DRUG LABEL	1	64406-008	INJECTION	300 mg	INTRAVENOUS	BLA	30 sections
TYSABRI	HUMAN PRESCRIPTION DRUG LABEL	1	64406-008	INJECTION	300 mg	INTRAVENOUS	BLA	30 sections
TYSABRI	HUMAN PRESCRIPTION DRUG LABEL	1	64406-008	INJECTION	300 mg	INTRAVENOUS	BLA	30 sections

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