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

Stem definition	Drug id	CAS RN
hirudin derivatives	385	128270-60-0

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: bivalirudin angiomax angiox hirulog	designed to bind to the alpha-thrombin catalytic site and anion-binding exosite for fibrin(ogen) recognition Molecular weight: 2180.32 Formula: C98H138N24O33 CLOGP: LIPINSKI: 3 HAC: 57 HDO: 28 TPSA: 901.57 ALOGS: -4.67 ROTB: 66

Molecule

Description

Molfile Inchi Smiles

Synonyms:

bivalirudin
angiomax
angiox
hirulog

designed to bind to the alpha-thrombin catalytic site and anion-binding exosite for fibrin(ogen) recognition

Molecular weight: 2180.32
Formula: C98H138N24O33
CLOGP:
LIPINSKI: 3
HAC: 57
HDO: 28
TPSA: 901.57
ALOGS: -4.67
ROTB: 66

Drug dosage:

Dose	Unit	Route
0.25	g	P

ADMET properties:

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Property	Value	Reference
CL (Clearance)	8.10 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	1 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	0.42 hours	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	0.27 L/kg	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
Dec. 15, 2000	FDA	MEDICINES CO

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
Coronary artery thrombosis	426.90	61.51	64	1633	1075	63486250
Thrombosis in device	285.74	61.51	52	1645	2938	63484387
Coagulation time abnormal	235.32	61.51	28	1669	59	63487266
Device occlusion	151.99	61.51	36	1661	7351	63479974
Retroperitoneal haemorrhage	132.30	61.51	27	1670	2770	63484555
Heparin-induced thrombocytopenia	129.92	61.51	29	1668	4553	63482772
Cardiac procedure complication	89.08	61.51	13	1684	177	63487148
Thrombosis	87.78	61.51	40	1657	64715	63422610
Coronary artery perforation	82.25	61.51	10	1687	27	63487298
Haemorrhage	71.21	61.51	34	1663	60988	63426337

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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
Thrombosis in device	512.37	54.38	100	2258	3225	34951348
Coronary artery thrombosis	483.80	54.38	89	2269	2070	34952503
Coagulation time abnormal	356.92	54.38	48	2310	108	34954465
Thrombosis	146.01	54.38	70	2288	50388	34904185
Procedural complication	138.27	54.38	36	2322	4247	34950326
Heparin-induced thrombocytopenia	133.32	54.38	37	2321	5558	34949015
Vascular stent thrombosis	106.07	54.38	27	2331	2908	34951665
Device occlusion	88.80	54.38	28	2330	6517	34948056
Acute myocardial infarction	80.06	54.38	48	2310	53671	34900902
Haemorrhage	74.21	54.38	45	2313	51325	34903248

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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
Coronary artery thrombosis	660.74	50.97	116	3627	2990	79737655
Thrombosis in device	608.11	50.97	118	3625	5324	79735321
Coagulation time abnormal	441.13	50.97	58	3685	170	79740475
Heparin-induced thrombocytopenia	258.61	50.97	65	3678	9617	79731028
Thrombosis	183.84	50.97	86	3657	84014	79656631
Procedural complication	175.93	50.97	46	3697	7937	79732708
Vascular stent thrombosis	172.42	50.97	39	3704	3671	79736974
Device occlusion	162.31	50.97	47	3696	11819	79728826
Acute myocardial infarction	132.75	50.97	67	3676	76969	79663676
Coagulation time prolonged	114.68	50.97	26	3717	2469	79738176

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	B01AE06	BLOOD AND BLOOD FORMING ORGANS ANTITHROMBOTIC AGENTS ANTITHROMBOTIC AGENTS Direct thrombin inhibitors
CHEBI has role	CHEBI:50249	anticoagulants
CHEBI has role	CHEBI:65232	thrombin inhibitors
FDA EPC	N0000175518	Direct Thrombin Inhibitor
FDA EPC	N0000175980	Anti-coagulant
FDA MoA	N0000009963	Thrombin Inhibitors
MeSH PA	D000925	Anticoagulants
MeSH PA	D000991	Antithrombins
MeSH PA	D004791	Enzyme Inhibitors
MeSH PA	D006401	Hematologic Agents

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID
Percutaneous coronary intervention	indication	415070008
Unstable Angina Pectoris during PTCA	indication
Acute coronary syndrome	off-label use	394659003
Intracranial hemorrhage	contraindication	1386000
Bleeding	contraindication	131148009

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	3.06	acidic
pKa10	12.84	acidic
pKa11	13.06	acidic
pKa12	13.08	acidic
pKa13	13.4	acidic
pKa14	13.64	acidic
pKa15	13.69	acidic
pKa16	13.81	acidic
pKa17	13.99	acidic
pKa18	10.75	Basic

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Orange Book patent data (new drug applications)

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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
Prothrombin	Enzyme	P00734	THRB_HUMAN	INHIBITOR	Ki	8.60		IUPHAR	CHEMBL

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External reference:

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ID	Source
009031	NDDF
129498009	SNOMEDCT_US
15879	MMSL
16129704	PUBCHEM_CID
234768	MMSL
285044	RXNORM
400610005	SNOMEDCT_US
4021268	VUID
4021268	VANDF
41019	MMSL

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Angiomax	HUMAN PRESCRIPTION DRUG LABEL	1	0781-3447	INJECTION	250 mg	INTRAVENOUS	NDA	25 sections
Angiomax	HUMAN PRESCRIPTION DRUG LABEL	1	0781-3447	INJECTION	250 mg	INTRAVENOUS	NDA	25 sections
Angiomax RTU	HUMAN PRESCRIPTION DRUG LABEL	1	70511-141	INJECTION, SOLUTION	250 mg	INTRAVENOUS	NDA	25 sections
Bivalirudin	HUMAN PRESCRIPTION DRUG LABEL	1	0409-8300	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	250 mg	INTRAVENOUS	ANDA	28 sections
Bivalirudin	HUMAN PRESCRIPTION DRUG LABEL	1	0409-8300	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	250 mg	INTRAVENOUS	ANDA	28 sections
Bivalirudin	HUMAN PRESCRIPTION DRUG LABEL	1	0409-8300	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	250 mg	INTRAVENOUS	ANDA	28 sections
Bivalirudin	HUMAN PRESCRIPTION DRUG LABEL	1	0409-8300	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	250 mg	INTRAVENOUS	ANDA	28 sections
bivalirudin	HUMAN PRESCRIPTION DRUG LABEL	1	0781-3158	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	250 mg	INTRAVENOUS	NDA authorized generic	25 sections
bivalirudin	HUMAN PRESCRIPTION DRUG LABEL	1	0781-9158	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	250 mg	INTRAVENOUS	NDA authorized generic	25 sections
Bivalirudin	HUMAN PRESCRIPTION DRUG LABEL	1	16729-275	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	250 mg	INTRAVENOUS	ANDA	25 sections

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