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Angiomax (BIVALIRUDIN)
Bivalirudin directly inhibits thrombin by binding to its catalytic site and anion-binding exosite, preventing thrombus formation.
Angiomax (Bivalirudin) is a small molecule anti-coagulant drug developed by Medicines Co and currently owned by Sandoz. It targets prothrombin to prevent blood clot formation, and is FDA-approved for percutaneous coronary intervention and unstable angina pectoris during PTCA. Bivalirudin has a short half-life of 0.42 hours and is available as a generic medication from multiple manufacturers. As an off-patent medication, its commercial status is primarily generic. Key safety considerations include bleeding risks and potential interactions with other medications.
At a glance
| Generic name | BIVALIRUDIN |
|---|---|
| Sponsor | Novartis |
| Drug class | Anti-coagulant [EPC] |
| Target | thrombin |
| Modality | Recombinant protein |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
| First approval | 2000 |
Mechanism of action
Bivalirudin works by directly binding to thrombin, a key enzyme in blood clotting. This binding blocks thrombin's ability to convert fibrinogen into fibrin and activate other factors that promote clotting and platelet aggregation, thus preventing the formation and stabilization of blood clots.
Approved indications
- Percutaneous coronary intervention
- Unstable Angina Pectoris during PTCA
Common side effects
- Bleeding
- Hypersensitivity and allergic reactions
- Anaphylaxis
- Lack of anticoagulant effect
- Thrombus formation
- Pulmonary hemorrhage
- Cardiac tamponade
- INR increased
- Immunogenicity
Drug interactions
- apixaban
- eptifibatide
- heparin
- pentosan polysulfate
- tirofiban
- warfarin
Key clinical trials
- Bivalirudin Versus Heparin During PCI in High Bleeding Risk Patients With Acute Coronary Syndromes (PHASE4)
- Multicenter Trial of ECMO in Children With Severe Cardiac Failure Using the Cardiohelp System (PHASE2)
- A Single Center Diagnostic, Cross-sectional Study of Coronary Microvascular Dysfunction (NA)
- Use of Bivalirudin for Anticoagulation in Patients With Extracorporeal Membrane Oxygenation (NA)
- Bivalirudin With Prolonged Full Dose Infusion Versus Heparin Alone During Emergency PCI (NA)
- A Study on the Impact of Bivalirudin Usage During PCI for High-risk Plaques on Post-PCI Coronary Microcirculation. (PHASE4)
- Pharmacokinetics of Bivalirudin for Pediatric Anticoagulation
- Bivalirudin with Prolonged Infusion During PCI Versus Heparin After Fibrinolytic Therapy (NA)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 11903993 | 2039-05-20 | Method of Use |
| 12472224 | 2039-05-20 | Formulation |
| 11918622 | 2039-05-20 | Method of Use |
| 11992514 | 2039-05-20 | Formulation |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |