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.
| Human dosing established | Yes |
|---|---|
| Route | Intravenous |
| Frequency | Intravenous bolus followed by continuous infusion |
| Duration studied | For the duration of the procedure; up to 4 hours afterwards may be considered in STEMI |
| Half-life | About 25 minutes with normal kidney function; longer with kidney impairment (3.5 hours in dialysis patients) |
| Evidence level | FDA Approved |
| Last reviewed | 2026-11-07 |
Research-reported dosing
Doses as studied, one row per regimen. Different trials used different regimens; they are listed separately rather than averaged.
| Study / context | Population | Dose | Route | Frequency | Duration | Outcome studied | Source |
|---|---|---|---|---|---|---|---|
| FDA label — anticoagulation during percutaneous coronary interventionFDA-approved label · FDA prescribing information | Adults undergoing PCI, including those with heparin-induced thrombocytopenia (HIT/HITTS), receiving aspirin | 0.75 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 it | Intravenous | Bolus, then continuous infusion | For the procedure; extending the infusion up to 4 hours after PCI should be considered in STEMI | Anticoagulation during PCI | Bivalirudin for injection (Sandoz, NDA 020873) — FDA prescribing information, DailyMed |
| FDA label — kidney impairmentFDA-approved label · FDA prescribing information | Adults undergoing PCI with creatinine clearance below 30 mL/min, or on hemodialysis | Same bolus; infusion reduced to 1 mg/kg/hour (creatinine clearance below 30 mL/min) or 0.25 mg/kg/hour (hemodialysis) | Intravenous | Bolus, then continuous infusion | For the procedure | Dose adjustment with anticoagulant monitoring | Bivalirudin 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.