BIVALIRUDIN

Description
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20873lbl.pdf | https://www.ncbi.nlm.nih.gov/pubmed/11833835

Bivalirudin is a synthetic 20 amino acid peptide rationally designed based on structural studies of hirudin, a naturally occurring anticoagulant. Bivalirudin is sold under the brand name Angiomax and is indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA). It is intended for use with aspirin and has been studied only in patients receiving concomitant aspirin. Bivalirudin directly inhibits thrombin by binding simultaneously to its active catalytic site and its substrate recognition site.

Approval Year

Targets

Primary Target	Pharmacology	Condition	Potency
Prothrombin 4 Target ID: P00734\|\|\|Q9UCA1 Gene ID: 2147.0 Gene Symbol: F2 Target Organism: Homo sapiens (Human) Sources: https://www.ncbi.nlm.nih.gov/pubmed/11833835	Inhibitor 8504

Conditions

Condition	Modality	Targets	Highest Phase	Product
unstable angina 2 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20873lbl.pdf	Palliative		Approved 8583	ANGIOMAX Approved Use Angiomax™ is indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA). Angiomax is intended for use with aspirin and has been studied only in patients receiving concomitant aspirin. Launch Date 2000

PubMed

Title	Date	PubMed
Antibodies against lepirudin are polyspecific and recognize epitopes on bivalirudin.	2004-01-15	14512301
Comparison of effectiveness and safety of three different antithrombotic regimens (bivalirudin, eptifibatide, and heparin) in preventing myocardial ischemia during percutaneous coronary intervention.	2003-11-01	14583359
Bivalirudin provides increasing benefit with decreasing renal function: a meta-analysis of randomized trials.	2003-10-15	14556866
Successful use of bivalirudin for cardiopulmonary bypass in a patient with heparin-induced thrombocytopenia.	2003-10	14579220
Direct thrombin inhibitors for non-ST-segment elevation acute coronary syndromes: what, when, and where?	2003-10	14564303
Argatroban for off-pump coronary artery bypass surgery.	2003-10	14500190
Heparin-induced thrombocytopenia: pathophysiology and new treatment options.	2003-09-19	13679659
Bivalirudin in percutaneous coronary intervention.	2003-09-15	14521034
Heparin-induced thrombocytopenia and cardiac surgery.	2003-08	12902132
Contemporary use of antiplatelet therapies in percutaneous coronary interventions.	2003-08	12878902
Can bivalirudin and provisional GP IIb/IIIa blockade REPLACE heparin and planned glycoprotein IIb/IIIa blockade during percutaneous coronary intervention?	2003-08	12877649
Economic impact of bleeding complications and the role of antithrombotic therapies in percutaneous coronary intervention.	2003-07-15	12908378
Current anticoagulant therapy--unmet clinical needs.	2003-07-15	12818628
A 24-hour continuous infusion study of bivalirudin in the rat.	2003-07-10	12851152
Hirulog-like peptide reduces restenosis and expression of tissue factor and transforming growth factor-beta in carotid artery of atherosclerotic rabbits.	2003-07	12860248
Bivalirudin use in off-pump myocardial revascularization in patients with heparin-induced thrombocytopenia [corrected].	2003-07	12842558
Bivalirudin in peripheral vascular interventions: a single center experience.	2003-07	12840239
Evolving role of bivalirudin in percutaneous coronary interventions; impact of the REPLACE-2 study.	2003-06	12783606
Bivalirudin as a foundation anticoagulant in peripheral vascular disease: a safe and feasible alternative for renal and iliac interventions.	2003-06	12777673
Correlation of point-of-care ecarin clotting time versus activated clotting time with bivalirudin concentrations.	2003-05-01	12714157
Predicting the pharmacology of thrombin inhibitors.	2003-05	12871372
Direct thrombin inhibitors.	2003-05	12739991
In-hospital complications of peripheral vascular interventions using unfractionated heparin as the primary anticoagulant.	2003-05	12730630
An assessment of different filter systems for extracorporeal elimination of bivalirudin: an in vitro study.	2003-05	12707125
Management of thrombotic and cardiovascular disorders in the new millenium.	2003-04	12812377
Anticoagulation in acute cardiac care in patients with chronic kidney disease.	2003-04	12679753
Informed consent during the clinical emergency of acute myocardial infarction (HERO-2 consent substudy): a prospective observational study.	2003-03-15	12648970
Safe and efficacious use of bivalirudin for percutaneous coronary intervention with adjunctive platelet glycoprotein IIb/IIIa receptor inhibition.	2003-03-15	12633814
Bivalirudin (Angiomax) use during intracoronary brachytherapy may predispose to acute closure.	2003-03	12652325
The evolving role of direct thrombin inhibitors in acute coronary syndromes.	2003-02-19	12644344
Should bivalirudin replace heparin during percutaneous coronary interventions?	2003-02-19	12588276
Bivalirudin and provisional glycoprotein IIb/IIIa blockade compared with heparin and planned glycoprotein IIb/IIIa blockade during percutaneous coronary intervention: REPLACE-2 randomized trial.	2003-02-19	12588269
Reversing anticoagulants both old and new.	2003-02-01	12557411
Clinician update: direct thrombin inhibitors in acute coronary syndromes.	2003-02	14574076
Bivalirudin monitored with the ecarin clotting time for anticoagulation during cardiopulmonary bypass.	2003-02	12538181
Alternative methods of anticoagulation for dialysis-dependent patients with heparin-induced thrombocytopenia.	2003-01-22	12535303
Favorable outcome with bivalirudin anticoagulation during cardiopulmonary bypass.	2003-01	12537226
Effect of non-heparin thrombin antagonists on thrombin generation, platelet function, and clot structure in whole blood.	2003	14515016
Direct thrombin inhibitors in cardiac disease.	2003	12668887
Anticoagulation with bivalirudin during cardiopulmonary bypass in cardiac surgery.	2002-12	12643418
A Bayesian ordinal model for heterogeneity in a multi-centre myocardial infarction clinical trial.	2002-10-30	12369078
Gateways to clinical trials.	2002-10	12500432
Direct thrombin inhibitors in acute coronary syndromes.	2002-08-10	12241752
Decreased platelet reactivity in blood anticoagulated with bivalirudin or enoxaparin compared with unfractionated heparin: implications for coronary intervention.	2002-06	12355033
Direct thrombin inhibitors.	2002-05-01	12356489
Current developments in antithrombotic therapy: the role of antithrombin agents.	2002	12811005
Current anticoagulation options in percutaneous intervention: designing patient-specific strategies.	2002	12556751
Optimal treatment and current situation in reperfusion after thrombolysis for acute myocardial infarction.	2002	12553491
Development and current applications of thrombin-specific inhibitors.	2001-06	12769663
Thrombin-specific inhibition by and slow cleavage of hirulog-1.	1992-05-01	1290488

Patents

Sample Use Guides

In Vivo Use Guide

The recommended dosage of Angiomax (bivalirudin) is an intravenous (IV) bolus dose of 1.0 mg/kg followed by a 4-hour IV infusion at a rate of 2.5 mg/kg/h. After completion of the initial 4-hour infusion, an additional IV infusion of Angiomax may be initiated at a rate of 0.2 mg/kg/h for up to 20 hours if needed.

Route of Administration: Intravenous

Substance Class	Protein Created by `admin` on `Wed Apr 02 08:41:11 GMT 2025` Edited by `admin` on `Wed Apr 02 08:41:11 GMT 2025`
Protein Sub Type
Sequence Type	COMPLETE
Record UNII	TN9BEX005G
Record Status	`Validated (UNII)`
Record Version

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Name

Type

Language

BIVALIRUDIN

Official Name

English

BG-8967

Preferred Name

English

bivalirudin [INN]

Common Name

English

BIVALIRUDIN [ORANGE BOOK]

Common Name

English

BIVALIRUDIN [VANDF]

Common Name

English

BIVALIRUDIN [MART.]

Common Name

English

Bivalirudin [WHO-DD]

Common Name

English

BIVALIRUDIN [EMA EPAR]

Common Name

English

L-LEUCINE, D-PHENYLALANYL-L-PROLYL-L-ARGINYL-L-PROLYLGLYCYLGLYCYLGLYCYLGLYCYL-L-ASPARAGINYLGLYCYL-L-.ALPHA.-ASPARTYL-L-PHENYLALANYL-L-.ALPHA.-GLUTAMYL-L-.ALPHA.-GLUTAMYL-L-ISOLEUCYL-L-PROLYL-L-.ALPHA.-GLUTAMYL-L-.ALPHA.-GLUTAMYL-L-TYROSYL-

Systematic Name

English

BIVALIRUDIN [MI]

Common Name

English

BIVALIRUDIN [USP-RS]

Common Name

English

BG8967

Code

English

BIVALIRUDIN [USAN]

Common Name

English

Classification Tree Code System Code

WHO-ATC

B01AE06