Anticoagulation Pregnancy: No data available on use in pregnant women to inform a drug-associated risk. Animal reproduction studies in rats and rabbits at subcutaneous doses up to 1.6 and 3.2 times the maximum recommended human dose revealed no evidence of fetal harm.

Bivalirudin

Brand names: Angiox

Bivalirudin is an intravenous direct thrombin inhibitor used as an anticoagulant during percutaneous coronary intervention and in the management of acute coronary syndromes, particularly where heparin-induced thrombocytopenia is a concern.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 0.75 mg/kg intravenous bolus, followed immediately by a 1.75 mg/kg/h intravenous infusion for the duration of the procedure. Five minutes after the bolus an activated clotting time (ACT) should be performed and an additional bolus of 0.3 mg/kg given if needed

Route: Intravenous bolus injection followed by continuous intravenous infusion (after reconstitution and dilution to 5 mg/mL)

Frequency: Bolus once at the start of the procedure (plus an optional 0.3 mg/kg re-bolus at 5 minutes per ACT), then continuous infusion for the duration of the procedure

Extended duration of infusion following PCI at 1.75 mg/kg/h for up to 4 hours post-procedure should be considered in patients with ST segment elevation MI (STEMI). Bivalirudin has been studied only in patients receiving concomitant aspirin. Preparation: add 5 mL Sterile Water for Injection to each 250 mg vial, swirl until dissolved, then add to a 50 mL bag of 5% dextrose or 0.9% sodium chloride (having withdrawn and discarded 5 mL) to give a final concentration of 5 mg/mL. Do not administer in the same intravenous line as alteplase, amiodarone, amphotericin B, chlorpromazine, diazepam, dobutamine, prochlorperazine edisylate, reteplase, streptokinase or vancomycin. Acute stent thrombosis (<4 hours) has occurred more frequently with bivalirudin than heparin in STEMI patients undergoing primary PCI — patients should remain monitored after PCI. THIS DOSE IS FROM THE US LABEL; no UK SPC posology was available in this bundle — verify against UK labelling before use.

Dose adjustments

Renal

No reduction in the bolus dose is needed for any degree of renal impairment. Maintenance infusion: if creatinine clearance is less than 30 mL/min (Cockcroft-Gault), reduce the infusion rate to 1 mg/kg/h; in patients on haemodialysis, reduce the infusion rate to 0.25 mg/kg/h. Monitor anticoagulant status in patients with renal impairment.

Dose auto-extracted from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Active major bleeding
Hypersensitivity (e.g. anaphylaxis) to bivalirudin or its components

Side effects

Bleeding — the most common adverse reaction (>2%); major bleeding in 3.7% of PCI patients in the BAT trials, including intracranial and retroperitoneal bleeding
Acute stent thrombosis (<4 hours) in STEMI patients undergoing primary PCI (1.2% vs 0.2% with heparin)
Increased thrombus formation, including fatal outcomes, with coronary artery gamma brachytherapy
Elderly patients experienced more bleeding events than younger patients
Immunogenicity — potential for antibody formation (as with all peptides)

Interactions

Heparin, warfarin, thrombolytics or glycoprotein IIb/IIIa inhibitors (GPIs) — coadministration was associated with increased risks of major bleeding events in PCI/PTCA trials

Clinical monograph

How it works

It binds directly and reversibly to both the catalytic site and substrate-binding exosite of thrombin, inhibiting fibrin formation and thrombin-mediated platelet activation.

Prescribing in practice

As with all anticoagulants the principal risk is bleeding, and the dose must be reduced according to renal function because clearance is partly renal.
It is administered as a bolus and infusion in the catheter-laboratory setting under specialist supervision, with attention to the transition timing to oral antiplatelet/anticoagulant therapy.
Acute stent thrombosis has been observed in the early hours after primary PCI, so peri-procedural antiplatelet cover and monitoring are important.

Monitoring

Monitor for bleeding, haemoglobin and renal function, with activated clotting time used to guide anticoagulation during the procedure.

Counselling the patient

Report any bleeding, bruising or signs of recurrent chest pain promptly.
Renal impairment requires dose adjustment.
It is an alternative anticoagulant when heparin-induced thrombocytopenia is suspected.

Evidence & guidelines

Bivalirudin during PCI has been evaluated in trials such as HORIZONS-AMI and is an established anticoagulant option in acute coronary syndrome pathways.

Reference: ESC NSTE-ACS Guidelines 2020; HORIZONS-AMI trial NEJM 2008; 358(21):2218-2230; NICE TA230; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways