Bivalirudin

CAS Number 128270-60-0
Molecular Formula C₉₈H₁₃₈N₂₄O₃₃
Molecular Weight 2180.3 g/mol
Purity ≥99.2%
Appearance White lyophilized powder

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Product Description

Bivalirudin is a synthetic 20–amino acid peptide that acts as a direct thrombin inhibitor, derived from hirudin, a natural anticoagulant found in leech saliva. Bivalirudin is designed for clinical use. It works by reversibly inhibiting both circulating and clot-bound thrombin, making it an effective anticoagulant. Bivalirudin is primarily used in percutaneous coronary interventions (PCI) and for patients with heparin-induced thrombocytopenia (HIT). It is cleared mainly by proteolytic cleavage and partially by renal excretion. Recent studies have shown its safety and efficacy as a heparin alternative in various procedures, including carotid artery stenting and in combination with antiplatelet agents like ticagrelor in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI.

Synthesis Methods

  • Synthetic Origin: Bivalirudin is a synthetic peptide derived from hirudin, a natural anticoagulant found in leech saliva.

  • Manufacturing: Typically synthesized through chemical peptide synthesis methods, ensuring purity and consistency for clinical use.

Uses

  • Clinical Uses:

    • Percutaneous Coronary Intervention (PCI): Used as an anticoagulant during PCI to prevent thrombosis.

    • Heparin-Induced Thrombocytopenia (HIT): Preferred anticoagulant for patients with a history of HIT.

    • Unstable Angina and Non-ST Segment Elevation Myocardial Infarction (UA/NSTEMI): Used in patients planned for urgent or early intervention.

    • Postoperative Aortopulmonary Shunt Thrombosis Prevention: Used in neonates undergoing stage 1 single-ventricle palliation to prevent shunt thrombosis.

  • Special Cases:

    • Large LA Thrombus: Successfully used in a high-risk patient with a history of HIT and a bioprosthetic mitral valve.

    • ECMO Support: Used in patients undergoing extracorporeal membrane oxygenation (ECMO) to prevent thrombosis.

Properties and Characteristics of Bivalirudin

  • Molecular Formula: C₉₈H₁₃₈N₂₄O₃₃

  • Molecular Weight: 2180.3 g/mol

  • Structure: Synthetic 20-amino acid peptide derived from hirudin (a natural anticoagulant found in leech saliva).

  • Mechanism of Action: Direct thrombin inhibitor, binds to both the catalytic site and anion-binding exosite of thrombin, preventing clot formation and platelet activation.

  • Pharmacokinetics:

    • Half-life: 25 minutes in patients with normal kidney function.

    • Metabolism: Primarily cleared by proteolytic cleavage (80%) and partially by renal excretion.

  • Chemical and Physical Properties:

    • Hydrogen Bond Donor Count: 28

    • Hydrogen Bond Acceptor Count: 35

    • Rotatable Bond Count: 67

    • Topological Polar Surface Area: 902 Ų

    • Heavy Atom Count: 155

    • Formal Charge: 0

    • Complexity: 4950

Safety and Hazards

  • Adverse Effects:

    • Bleeding Complications: Major adverse effect is bleeding, which can be severe in some cases.

    • Hypotension, Backache, and Nausea: Common side effects.

  • Drug-Drug Interactions:

    • Increased Bleeding Risk: When used concomitantly with other anticoagulants or antiplatelet agents (e.g., warfarin, heparin, aspirin).

  • Contraindications:

    • Active Bleeding: Should not be used in patients with active or recent bleeding events.

    • Severe Renal Insufficiency: Use with caution in patients with severe renal impairment.

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