Bivalirudin
Direct Thrombin Inhibitors
Sold as ANGIOMAX
- Drug class
- Direct Thrombin Inhibitors
- Availability
- Prescription only
- Routes
- Intravenous
- Markets covered
- 3
- Products on record
- 9
- FDA reports (12 mo)
- 60
Overview
Bivalirudin is an active pharmaceutical ingredient in the Direct Thrombin Inhibitors group (B01AE). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| CA Canada | Health Canada | 5 | March 26, 2025 |
| GB United Kingdom | MHRA | 3 | May 1, 2026 |
| US United States | FDA | 1 | September 10, 2025 |
CACanada· Health Canada
5 products
Uses
BIVALIRUDIN INJECTION (bivalirudin) is indicated for: use as an anticoagulant in patients undergoing percutaneous coronary intervention and in the treatment of patients with moderate to high risk acute coronary syndromes due to unstable angina or non-ST-segment elevation in whom early percutaneous coronary intervention is planned (see DOSAGE AND ADMINISTRATION – Use Subsequent to Unfractionated Heparin (UFH) or Low Molecular Weight Heparin (LMWH)) the treatment of patients with acute coronary syndromes due to ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI).
BIVALIRUDIN INJECTION is intended for use with acetylsalicylic acid (ASA) and has been studied only in patients receiving concomitant ASA. Clopidogrel can also be administered. BIVALIRUDIN INJECTION is also indicated in patients with or at risk of heparin induced thrombocytopenia or heparin induced thrombocytopenia thrombosis syndrome (HIT/TS) undergoing PCI or cardiac surgery.
GBUnited Kingdom· MHRA
3 products
Uses
Bivalirudin is indicated as an anticoagulant in adult patients undergoing percutaneous coronary intervention (PCI), including patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI. Bivalirudin is also indicated for the treatment of adult patients with unstable angina/ non-ST segment elevation myocardial infarction (UA/NSTEMI) planned for urgent or early intervention.
Bivalirudin should be administered with acetylsalicylic acid and clopidogrel.
How to take
USUnited States· FDA
1 product
Uses
1 INDICATIONS AND USAGE Bivalirudin for injection is indicated for use as an anticoagulant for use in patients undergoing percutaneous coronary intervention (PCI) including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome.
( 1 )
How to take
Drug interactions
Known interactions involving Bivalirudin. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]Health Canada (DPD) · 02505517 · revised March 22, 2025
- [2]MHRA (UK) · PL200750438 · revised May 1, 2026
- [3]FDA DailyMed · 19a4afc5-151d-4d… · revised September 10, 2025 [PDF]
- [4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.