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

Stem definition	Drug id	CAS RN
blood coagulation factor XA inhibitors, antithrombotics	4897	480449-70-5

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: edoxaban tosylate edoxaban edoxaban tosilate edoxaban tosilate hydrate lixiana DU-176b savaysa	An orally active inhibitor of coagulation factor Xa (activated factor X) with anticoagulant activity. Edoxaban is administered as edoxaban tosylate. This agent has an elimination half-life of 9-11 hours and undergoes renal excretion. Molecular weight: 548.06 Formula: C24H30ClN7O4S CLOGP: 1.86 LIPINSKI: 2 HAC: 11 HDO: 3 TPSA: 136.63 ALOGS: -4.68 ROTB: 6 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

edoxaban tosylate
edoxaban
edoxaban tosilate
edoxaban tosilate hydrate
lixiana
DU-176b
savaysa

An orally active inhibitor of coagulation factor Xa (activated factor X) with anticoagulant activity. Edoxaban is administered as edoxaban tosylate. This agent has an elimination half-life of 9-11 hours and undergoes renal excretion.

Molecular weight: 548.06
Formula: C24H30ClN7O4S
CLOGP: 1.86
LIPINSKI: 2
HAC: 11
HDO: 3
TPSA: 136.63
ALOGS: -4.68
ROTB: 6

Status: ONP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
60	mg	O

ADMET properties:

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Property	Value	Reference
t_half (Half-life)	6.70 hours	Lombardo F, Berellini G, Obach RS
CL (Clearance)	5.19 mL/min/kg	Lombardo F, Berellini G, Obach RS
BDDCS (Biopharmaceutical Drug Disposition Classification System)	4	Hosey CM, Chan R, Benet LZ
Vd (Volume of distribution)	1.53 L/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.50 %	Lombardo F, Berellini G, Obach RS
S (Water solubility)	0.09 mg/mL	Bocci G, Oprea TI, Benet LZ

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Approvals:

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Date	Agency	Company
April 22, 2011	PMDA	DAIICHI SANKYO COMPANY, Limited
Jan. 8, 2015	FDA	DAIICHI SANKYO
June 19, 2015	EMA	Daiichi Sankyo Europe GmbH

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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
General physical health deterioration	275.48	21.04	264	12385	201138	63275235
Anaemia	233.43	21.04	289	12360	293141	63183232
Cardiac failure	182.11	21.04	147	12502	88995	63387378
Labelled drug-drug interaction medication error	142.15	21.04	64	12585	13335	63463038
Melaena	138.03	21.04	82	12567	30283	63446090
Renal impairment	136.13	21.04	124	12525	88231	63388142
Product monitoring error	132.03	21.04	45	12604	4471	63471902
Atrial fibrillation	124.50	21.04	134	12515	116502	63359871
Haematochezia	115.00	21.04	91	12558	53453	63422920
Drug ineffective	103.31	21.04	40	12609	1044725	62431648

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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
General physical health deterioration	148.88	18.37	187	10251	128082	34818411
Renal impairment	141.46	18.37	157	10281	94356	34852137
Anaemia	139.37	18.37	249	10189	233086	34713407
Cerebral infarction	131.76	18.37	89	10349	27366	34919127
Haematuria	116.98	18.37	106	10332	49960	34896533
Cardiac failure	102.47	18.37	131	10307	91117	34855376
Atrial fibrillation	97.56	18.37	149	10289	122244	34824249
Melaena	94.80	18.37	81	10357	35299	34911194
Product monitoring error	88.04	18.37	37	10401	4344	34942149
Pelvic mass	87.67	18.37	19	10419	214	34946279

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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
General physical health deterioration	410.64	16.53	441	21748	274797	79447402
Anaemia	352.13	16.53	519	21670	444496	79277703
Renal impairment	274.68	16.53	275	21914	157508	79564691
Cardiac failure	251.50	16.53	260	21929	154582	79567617
Cerebral infarction	213.80	16.53	142	22047	45534	79676665
Melaena	209.93	16.53	157	22032	60733	79661466
Atrial fibrillation	209.03	16.53	266	21923	197620	79524579
Product monitoring error	207.56	16.53	82	22107	8824	79713375
Haematuria	182.40	16.53	152	22037	68684	79653515
Labelled drug-drug interaction medication error	159.25	16.53	98	22091	27552	79694647

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	B01AF03	BLOOD AND BLOOD FORMING ORGANS ANTITHROMBOTIC AGENTS ANTITHROMBOTIC AGENTS Direct factor Xa inhibitors
CHEBI has role	CHEBI:50249	anticoagulants
CHEBI has role	CHEBI:50427	platelet aggregation inhibitors
CHEBI has role	CHEBI:68581	factor Xa inhibitors
FDA EPC	N0000175637	Factor Xa Inhibitor
FDA MoA	N0000175635	Factor Xa Inhibitors
MeSH PA	D000925	Anticoagulants
MeSH PA	D000991	Antithrombins
MeSH PA	D004791	Enzyme Inhibitors
MeSH PA	D065427	Factor Xa 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
Pulmonary embolism	indication	59282003	DOID:9477
Embolism	indication	414086009
Ischemic stroke	indication	422504002
Prevention of deep vein thrombosis	indication	439993001

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

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Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	11.7	acidic
pKa2	12.4	acidic
pKa3	6.8	Basic
pKa4	3.01	Basic
pKa5	2.14	Basic

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Orange Book patent data (new drug applications)

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Orange Book exclusivity data (new drug applications)

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Coagulation factor X	Enzyme	P00742	FA10_HUMAN	INHIBITOR	Ki	9.25		SCIENTIFIC LITERATURE	SCIENTIFIC LITERATURE

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External reference:

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ID	Source
015852	NDDF
015853	NDDF
10280735	PUBCHEM_CID
1162278009	SNOMEDCT_US
1599538	RXNORM
232451	MMSL
30841	MMSL
30865	MMSL
4034081	VANDF
480449-71-6	SECONDARY_CAS_RN

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
SAVAYSA	HUMAN PRESCRIPTION DRUG LABEL	1	65597-201	TABLET, FILM COATED	15 mg	ORAL	NDA	34 sections
SAVAYSA	HUMAN PRESCRIPTION DRUG LABEL	1	65597-201	TABLET, FILM COATED	15 mg	ORAL	NDA	34 sections
SAVAYSA	HUMAN PRESCRIPTION DRUG LABEL	1	65597-201	TABLET, FILM COATED	15 mg	ORAL	NDA	34 sections
SAVAYSA	HUMAN PRESCRIPTION DRUG LABEL	1	65597-202	TABLET, FILM COATED	30 mg	ORAL	NDA	34 sections
SAVAYSA	HUMAN PRESCRIPTION DRUG LABEL	1	65597-202	TABLET, FILM COATED	30 mg	ORAL	NDA	34 sections
SAVAYSA	HUMAN PRESCRIPTION DRUG LABEL	1	65597-202	TABLET, FILM COATED	30 mg	ORAL	NDA	34 sections
SAVAYSA	HUMAN PRESCRIPTION DRUG LABEL	1	65597-203	TABLET, FILM COATED	60 mg	ORAL	NDA	34 sections
SAVAYSA	HUMAN PRESCRIPTION DRUG LABEL	1	65597-203	TABLET, FILM COATED	60 mg	ORAL	NDA	34 sections
SAVAYSA	HUMAN PRESCRIPTION DRUG LABEL	1	65597-203	TABLET, FILM COATED	60 mg	ORAL	NDA	34 sections

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