Bivalirudin: Difference between revisions

Revision as of 23:06, 10 March 2014

Bivalirudin
ANGIOMAX^® FDA Package Insert
Indications and Usage
Dosage and Administration
Dosage Forms and Strengths
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
Clinical Studies
How Supplied/Storage and Handling
Patient Counseling Information
Labels and Packages
Clinical Trials on Bivalirudin
ClinicalTrials.gov

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Jesus Rosario Hernandez, M.D. [2]

For patient information about Bivalirudin, click here.

Synonyms / Brand Names: ANGIOMAX^®

Overview

Bivalirudin (Angiomax or Angiox, manufactured by The Medicines Company) is a specific and reversible direct thrombin inhibitor (DTI).

Chemically, it is a synthetic congener of the naturally occurring drug hirudin (found in the saliva of the medicinal leech Hirudo medicinalis).

Bivalirudin is a DTI that overcomes many limitations seen with indirect thrombin inhibitors, such as heparin. Bivalirudin is a short, synthetic peptide that is potent, highly specific, and a reversible inhibitor of thrombin. It inhibits both circulating and clot-bound thrombin, while also inhibiting thrombin-mediated platelet activation and aggregation. It does not bind to plasma proteins (other than thrombin) or to red blood cells. Therefore it has a predictable antithrombotic response. There is no risk for Heparin Induced Thrombocytopenia/Heparin Induced Thrombosis-Thrombocytopenia Syndrome (HIT/HITTS). It does not require a binding cofactor such as antithrombin and does not activate platelets. These characteristics make bivalirudin an ideal alternative to heparin.

Bivalirudin clinical studies demonstrated consistent positive outcomes in patients with stable angina, unstable angina (UA), non-ST segment elevation myocardial infarction (NSTEMI), and ST-segment elevation myocardial infarction (STEMI) undergoing PCI in 7 major randomized trials.

FDA Package Insert

Label Title

Mechanism of Action

References

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 ==Overview==
-'''Bivalirudin''' (Angiomax or Angiox, manufactured by The Medicines Company) is a specific and reversible [[direct thrombin inhibitor]] (DTI).<ref name=Angiomax>{{cite web |url= http://angiomax.com/Downloads/Angiomax_PI_2010_PN1601-12.pdf|title= Angiomax (bivalirudin) Prescribing Information|work= |publisher= The Medicines Company|accessdate=2 December 2011}}{{dead link|date=September 2013}}</ref>
+'''Bivalirudin''' (Angiomax or Angiox, manufactured by The Medicines Company) is a specific and reversible [[direct thrombin inhibitor]] (DTI).
-Chemically, it is a synthetic [[Congener (chemistry)|congener]] of the naturally occurring drug [[hirudin]] (found in the saliva of the medicinal leech ''Hirudo medicinalis'').
+Chemically, it is a synthetic congener of the naturally occurring drug [[hirudin]] (found in the saliva of the medicinal leech ''Hirudo medicinalis'').
-Bivalirudin is a DTI that overcomes many limitations seen with indirect thrombin inhibitors, such as [[heparin]]. Bivalirudin is a short, synthetic peptide that is potent, highly specific, and a reversible inhibitor of [[thrombin]].<ref name=Angiomax /><ref name=Anand2007>{{cite pmid|17659921}}</ref><ref name=Weitz1990>{{cite pmid|2384594}}</ref> It inhibits both circulating and clot-bound thrombin,<ref name=Weitz1990 /> while also inhibiting thrombin-mediated platelet activation and aggregation.<ref name=Stone2006>{{cite pmid|17124018}}</ref> Bivalirudin has a quick onset of action and a short half-life.<ref name=Angiomax /> It does not bind to plasma proteins (other than thrombin) or to red blood cells. Therefore it has a predictable antithrombotic response. There is no risk for [[Heparin-induced thrombocytopenia|Heparin Induced Thrombocytopenia]]/Heparin Induced Thrombosis-Thrombocytopenia Syndrome (HIT/HITTS).<ref name=Angiomax /> It does not require a binding cofactor such as antithrombin and does not activate platelets.<ref name=Anand2007 /><ref name=Weitz2002>{{cite pmid|11967385}}</ref> These characteristics make bivalirudin an ideal alternative to heparin.
+Bivalirudin is a DTI that overcomes many limitations seen with indirect thrombin inhibitors, such as [[heparin]]. Bivalirudin is a short, synthetic peptide that is potent, highly specific, and a reversible inhibitor of [[thrombin]]. It inhibits both circulating and clot-bound thrombin, while also inhibiting thrombin-mediated platelet activation and aggregation. It does not bind to plasma proteins (other than thrombin) or to red blood cells. Therefore it has a predictable antithrombotic response. There is no risk for [[Heparin-induced thrombocytopenia|Heparin Induced Thrombocytopenia]]/Heparin Induced Thrombosis-Thrombocytopenia Syndrome (HIT/HITTS). It does not require a binding cofactor such as antithrombin and does not activate platelets. These characteristics make bivalirudin an ideal alternative to heparin.
-Bivalirudin clinical studies demonstrated consistent positive outcomes in patients with stable [[angina]], unstable angina (UA), non-ST segment elevation myocardial infarction (NSTEMI), and ST-segment elevation myocardial infarction (STEMI) undergoing PCI  in 7 major randomized trials.<ref name=Angiomax /><ref name=Weitz1990 /><ref name=Stone2006 /><ref name=Bittl2001>{{cite pmid|11717596}}</ref><ref name=Lincoff2003>{{cite pmid|12588269}}</ref>
+Bivalirudin clinical studies demonstrated consistent positive outcomes in patients with stable [[angina]], unstable angina (UA), non-ST segment elevation myocardial infarction (NSTEMI), and ST-segment elevation myocardial infarction (STEMI) undergoing PCI  in 7 major randomized trials.
 ==Category==