Bivalirudin dosage in published studies and labels

These are the doses used for Bivalirudin in FDA labelling and published clinical studies, reported as each source states them, one row per regimen. They describe what was studied or approved for a specific population. They are not a recommendation, and none of them is a dose for any individual.

Research and educational reference only. This is not medical advice, and no figure on this page is a dosing recommendation.

Last checked against primary sources:

Studied regimens and sources

Bivalirudin has an FDA-approved human dosage as an intravenous anticoagulant for adults undergoing percutaneous coronary intervention (PCI), including people with heparin-induced thrombocytopenia. The label's recommended dose is a 0.75 mg/kg intravenous bolus followed immediately by an infusion of 1.75 mg/kg per hour for the duration of the procedure, given with aspirin.

FDA Approved
Dosage evidence summary for Bivalirudin
Human dosing establishedYes
RouteIntravenous
FrequencyIntravenous bolus followed by continuous infusion
Duration studiedFor the duration of the procedure; up to 4 hours afterwards may be considered in STEMI
Half-lifeAbout 25 minutes with normal kidney function; longer with kidney impairment (3.5 hours in dialysis patients)
Evidence levelFDA Approved
Last reviewed2026-11-07

Research-reported dosing

Doses as studied, one row per regimen. Different trials used different regimens; they are listed separately rather than averaged.

Research-reported dosing for Bivalirudin, one row per studied regimen
Study / contextPopulationDoseRouteFrequencyDurationOutcome studiedSource
FDA label — anticoagulation during percutaneous coronary interventionFDA-approved label · FDA prescribing informationAdults undergoing PCI, including those with heparin-induced thrombocytopenia (HIT/HITTS), receiving aspirin0.75 mg/kg bolus, then 1.75 mg/kg/hour; an extra 0.3 mg/kg bolus if the activated clotting time 5 minutes later calls for itIntravenousBolus, then continuous infusionFor the procedure; extending the infusion up to 4 hours after PCI should be considered in STEMIAnticoagulation during PCIBivalirudin for injection (Sandoz, NDA 020873) — FDA prescribing information, DailyMed
FDA label — kidney impairmentFDA-approved label · FDA prescribing informationAdults undergoing PCI with creatinine clearance below 30 mL/min, or on hemodialysisSame bolus; infusion reduced to 1 mg/kg/hour (creatinine clearance below 30 mL/min) or 0.25 mg/kg/hour (hemodialysis)IntravenousBolus, then continuous infusionFor the procedureDose adjustment with anticoagulant monitoringBivalirudin for injection (Sandoz, NDA 020873) — FDA prescribing information, DailyMed

Where sources disagree

  • Bivalirudin is a direct thrombin inhibitor used during PCI. The label warns that it increases the risk of bleeding, that acute stent thrombosis was more frequent in STEMI patients undergoing primary PCI, and that thrombus formation, including fatal cases, was more likely during gamma brachytherapy. There is no known antidote.
  • Overdoses reported in trials and after marketing were often due to not reducing the infusion in people with kidney impairment, according to the label. Safety and effectiveness in children have not been established.
  • The label describes a 250 mg vial that is reconstituted and then diluted before intravenous use.