Overview
Lepirudin is a recombinant hirudin formed by 65 amino acids that acts as a highly specific and direct thrombin inhibitor. Natural hirudin is an endogenous anticoagulant found in Hirudo medicinalis leeches. Lepirudin is produced in yeast cells and is identical to natural hirudin except for the absence of sulfate on the tyrosine residue at position 63 and the substitution of leucine for isoleucine at position 1 (N-terminal end). Lepirudin is used as an anticoagulant in patients with heparin-induced thrombocytopenia (HIT), an immune reaction associated with a high risk of thromboembolic complications. HIT is caused by the expression of immunoglobulin G (IgG) antibodies that bind to the complex formed by heparin and platelet factor 4. This activates endothelial cells and platelets and enhances the formation of thrombi. Bayer ceased the production of lepirudin (Refludan) effective May 31, 2012.
Indication
Lepirudin is indicated for anticoagulation in adult patients with acute coronary syndromes (ACS) such as unstable angina and acute myocardial infarction without ST elevation. In patients with ACS, lepirudin is intended for use with aspirin. Lepirudin is also indicated for anticoagulation in patients with heparin-induced thrombocytopenia (HIT) and associated thromboembolic disease in order to prevent further thromboembolic complications.
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
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2023/05/06 | Phase 4 | Recruiting | |||
2011/02/25 | N/A | Completed | |||
2008/11/26 | Phase 4 | Terminated | Heinrich-Heine University, Duesseldorf | ||
2002/06/10 | Phase 2 | Completed |
FDA Drug Approvals
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No FDA approvals found for this drug. |
EMA Drug Approvals
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No EMA approvals found for this drug. |
HSA Drug Approvals
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No HSA approvals found for this drug. |
NMPA Drug Approvals
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No NMPA approvals found for this drug. |
PPB Drug Approvals
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No PPB approvals found for this drug. |
TGA Drug Approvals
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No TGA approvals found for this drug. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
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REFLUDAN | Bayer Inc | 02240996 | Powder For Solution - Intravenous | 50 MG / VIAL | 1/31/2000 |
CIMA AEMPS Drug Approvals
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No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
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No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
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No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
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No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
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No UK EMC drug information found for this drug. |
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