Bivalirudin

Direct Thrombin Inhibitor (synthetic Hirudin Analog)Rx: PrescriptionCompound: Approved

Also known as: Angiomax, Angiox, BG-8967, Hirulog

Educational Only — Not medical advice. Consult a qualified clinician before using any peptide.

Summary

Bivalirudin is a synthetic 20-amino acid peptide analog of hirudin used as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI) and in patients with or at risk of heparin-induced thrombocytopenia (HIT). It offers predictable pharmacokinetics, short half-life (~25 minutes), and does not require antithrombin as a cofactor.

Mechanism of Action

Bivalirudin is a bivalent direct thrombin inhibitor that binds simultaneously to both the catalytic site and the anion-binding exosite I of thrombin, reversibly inhibiting thrombin-mediated cleavage of fibrinogen, activation of coagulation factors, and platelet aggregation.

Routes of Administration

Intravenous

Goals & Uses

  • Management of heparin-induced thrombocytopenia (HIT)AnticoagulationHigh
  • Anticoagulation during percutaneous coronary intervention (PCI)AnticoagulationHigh
  • Anticoagulation during ECMOAnticoagulationLow
  • Reduction of bleeding complications in ACSHemostasisHigh
  • Anticoagulation during cardiac surgery (off-pump/CABG)AnticoagulationModerate

Contraindications

  • Severe renal impairment (GFR <30 mL/min) without dose adjustmentRenalModerate
  • Active major bleedingHemorrhagic RiskHigh
  • Severe hypersensitivity to bivalirudin or hirudin analogsAllergy/ImmunologyHigh

Adverse Effects

  • Injection site reactionsLocalUncommon
  • Hypersensitivity/anaphylaxisImmunologicalRare
  • Acute stent thrombosisThromboticUncommon
  • HypotensionCardiovascularUncommonLow blood pressure
  • Nausea/vomitingGastrointestinalUncommon
  • Bleeding (minor and major)HemorrhagicCommon

Drug Interactions

  • WarfarinModerate
  • Thrombolytics (e.g., alteplase, tenecteplase)High
  • Glycoprotein IIb/IIIa inhibitors (e.g., abciximab, eptifibatide)Moderate
  • Low molecular weight heparins (LMWHs)High
  • Unfractionated HeparinHigh

Population Constraints

  • PregnancyReproductive SafetyRelative
  • Renal impairmentOrgan ImpairmentRelative
  • Pediatric patientsAgeRelative
  • Elderly patientsAgeRelative

Regulatory Status

  • European UnionApprovedApproved: Anticoagulation in adults undergoing PCI including STEMI patients undergoing primary PCI, Treatment of adults with ST-segment elevation STEMI undergoing primary PCIEMA approved under brand name Angiox; centralized authorization.
  • United StatesApprovedApproved: Anticoagulation in patients undergoing PCI, Patients with unstable angina undergoing PTCA, Patients with or at risk of HIT/HITTS undergoing PCIFDA approved in 2000; brand name Angiomax; generic formulations available since 2015.
  • United KingdomApprovedApproved: Anticoagulation in adults undergoing PCI, STEMI patients undergoing primary PCIRetained EU approval post-Brexit; marketed as Angiox in the UK.

Approved by the FDA in 2000 under the brand name Angiomax for use in PCI and HIT. Also approved by the EMA. Generic formulations (bivalirudin) are available in the US and EU.

Evidence & Sources

No sources recorded yet.

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