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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.
Bivalirudin has a quick onset of action and a short half-life.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.
|Single Impurity (HPLC)||0.5%max|
|Amino Acid Composition||±10% of theoretical|
|Peptide Content (N%)||≥80.0%|
|Water Content (Karl Fischer)||≤8.0%|
|Acetate Content (HPIC)||≤12.0%|
1) Bivalirudin is a DTI that overcomes many limitations seen with indirect thrombin inhibitors, such as heparin.
2) Bivalirudin is indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA).
3) Bivalirudin with provisional use of glycoprotein IIb/IIIa inhibitor (GPI) is indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI).
4) Bivalirudin is indicated for patients with, or at risk of HIT/HITTS undergoing PCI.
Bivalirudin is intended for use with aspirin and has been studied only in patients receiving concomitant aspirin.