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Statements

Subject Item
n2:DB00006
rdf:type
n5:Drug
n5:description
Bivalirudin is a synthetic 20 residue peptide (thrombin inhibitor) which reversibly inhibits thrombin. Once bound to the active site, thrombin cannot activate fibrinogen into fibrin, the crucial step in the formation of thrombus. It is administered intravenously. Because it can cause blood stagnation, it is important to monitor changes in hematocrit, activated partial thromboplastin time, international normalized ratio and blood pressure.
n5:dosage
n24:271B3EC7-363D-11E5-9242-09173F13E4C5 n24:271B3EC8-363D-11E5-9242-09173F13E4C5 n24:271B3EC9-363D-11E5-9242-09173F13E4C5
n5:generalReferences
# Seybert AL, Coons JC, Zerumsky K: Treatment of heparin-induced thrombocytopenia: is there a role for bivalirudin? Pharmacotherapy. 2006 Feb;26(2):229-41. "Pubmed":http://www.ncbi.nlm.nih.gov/pubmed/16466327 # Dager WE, Dougherty JA, Nguyen PH, Militello MA, Smythe MA: Heparin-induced thrombocytopenia: treatment options and special considerations. Pharmacotherapy. 2007 Apr;27(4):564-87. "Pubmed":http://www.ncbi.nlm.nih.gov/pubmed/17381384 # Dang CH, Durkalski VL, Nappi JM: Evaluation of treatment with direct thrombin inhibitors in patients with heparin-induced thrombocytopenia. Pharmacotherapy. 2006 Apr;26(4):461-8. "Pubmed":http://www.ncbi.nlm.nih.gov/pubmed/16553503 # Robson R: The use of bivalirudin in patients with renal impairment. J Invasive Cardiol. 2000 Dec;12 Suppl F:33F-6. "Pubmed":http://www.ncbi.nlm.nih.gov/pubmed/11156732 # Van De Car DA, Rao SV, Ohman EM: Bivalirudin: a review of the pharmacology and clinical application. Expert Rev Cardiovasc Ther. 2010 Dec;8(12):1673-81. "Pubmed":http://www.ncbi.nlm.nih.gov/pubmed/21108549 # Shammas NW: Bivalirudin: pharmacology and clinical applications. Cardiovasc Drug Rev. 2005 Winter;23(4):345-60. "Pubmed":http://www.ncbi.nlm.nih.gov/pubmed/16614733 # Gleason TG, Chengelis CP, Jackson CB, Lindstrom P: A 24-hour continuous infusion study of bivalirudin in the rat. Int J Toxicol. 2003 May-Jun;22(3):195-206. "Pubmed":http://www.ncbi.nlm.nih.gov/pubmed/12851152
n5:group
approved investigational
n5:halfLife
* Normal renal function: 25 min (in normal conditions) * Creatinine clearance 10-29mL/min: 57min * Dialysis-dependant patients: 3.5h
n5:indication
For treatment of heparin-induced thrombocytopenia and for the prevention of thrombosis. Bivalirudin is indicated for use in patients undergoing percutaneous coronary intervention (PCI), in patients at moderate to high risk acute coronary syndromes due to unstable angina or non-ST segment elevation in whom a PCI is planned.
n5:manufacturer
n15:271B3EC5-363D-11E5-9242-09173F13E4C5
owl:sameAs
n11:DB00006 n14:DB00006
dcterms:title
Bivalirudin
adms:identifier
n4:65293-001-01 n9:DB00006 n12:PA10032 n13:Bivalirudin n21:D03136
n5:mechanismOfAction
Inhibits the action of thrombin by binding both to its catalytic site and to its anion-binding exosite. Thrombin is a serine proteinase that plays a central role in the thrombotic process, acting to cleave fibrinogen into fibrin monomers and to activate Factor XIII to Factor XIIIa, allowing fibrin to develop a covalently cross-linked framework which stabilizes the thrombus; thrombin also activates Factors V and VIII, promoting further thrombin generation, and activates platelets, stimulating aggregation and granule release.
n5:packager
n15:271B3EC4-363D-11E5-9242-09173F13E4C5 n15:271B3EC2-363D-11E5-9242-09173F13E4C5 n15:271B3EC3-363D-11E5-9242-09173F13E4C5 n15:271B3EC1-363D-11E5-9242-09173F13E4C5
n5:patent
n19:7582727 n19:5196404 n19:2065150
n5:routeOfElimination
Bivalirudin is cleared from plasma by a combination of renal mechanisms (20%) and proteolytic cleavage.
n5:toxicity
Based on a study by Gleason et al., the no-observed-adverse-effect level (NOAEL) for bivalirudin, administered to rats via intravenous infusion over a 24-hour period, was 2000 mg/kg/24 h.
n5:volumeOfDistribution
0.2L/kg
n16:hasAHFSCode
n23:20-12-04-12
n5:foodInteraction
Echinacea Dan shen, dong quai, evening primrose oil, gingko, policosanol, willow bark
n5:proteinBinding
Other than thrombin and red blood cells, bivalirudin does not bind to plasma proteins.
n5:synthesisReference
Avi Tovi, Chaim Eidelman, Shimon Shushan, Alon Hagi, Alexander Ivchenko, Gabriel-Marcus Butilca, Leah Bar-Oz, Tehila Gadi, Gil Zaovi, "Process for production of Bivalirudin." U.S. Patent US20070093423, issued April 26, 2007.
foaf:page
n7:angiomax.htm n22:bivalirudin.html
n5:Molecular-Formula
n18:271B3ECD-363D-11E5-9242-09173F13E4C5
n5:Molecular-Weight
n18:271B3ECC-363D-11E5-9242-09173F13E4C5
n16:hasATCCode
n17:B01AE06
n5:absorption
Following intravenous administration, bivalirudin exhibits linear pharmacokinetics . The mean steady state concentration is 12.3 +/- 1.7mcg/mL after administration of an intravenous bolus of 1mg/kg followd by a 2.5mg/kg/hr intravenous infusion given over 4 hours.
n5:affectedOrganism
Humans and other mammals
n5:casRegistryNumber
128270-60-0
n5:category
n5:clearance
* 3.4 mL/min/kg [Normal renal function] * 3.4 mL/min/kg [mild renal function] * 2.7 mL/min/kg [moderate renal function] * 2.8 mL/min/kg [severe renal function] * 1 mL/min/kg [Dialysis-dependent patients]
n5:containedIn
n20:271B3EC6-363D-11E5-9242-09173F13E4C5
n5:Hydrophobicity
n18:271B3ECA-363D-11E5-9242-09173F13E4C5
n5:Isoelectric-Point
n18:271B3ECB-363D-11E5-9242-09173F13E4C5