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Fresenius Kabi’s Bivalirudin for Injection, a generic alternative to The Medicines Company’s Angiomax, is now available in the US.
Bivalirudin is a direct thrombin inhibitor indicated for use as an anticoagulant.
Fresenius Kabi’s Bivalirudin for Injection was approved by the US Food and Drug Administration in October.
Bivalirudin for Injection is now available in single-dose vials, each containing 250 mg of bivalirudin.
Bivalirudin for Injection was developed and is manufactured in the US.
Bivalirudin for Injection is indicated for use in:
- Patients with unstable angina who are undergoing percutaneous transluminal coronary angioplasty (PTCA)
- Patients undergoing percutaneous coronary intervention (PCI) with provisional use of glycoprotein IIb/IIIa inhibitors, as in the REPLACE-2 study
- Patients with, or at risk of, heparin-induced thrombocytopenia or heparin-induced thrombocytopenia and thrombosis syndrome who are undergoing PCI.
Bivalirudin for Injection is intended for use with aspirin.
The safety and effectiveness of Bivalirudin for Injection has not been established in patients with acute coronary syndromes who are not undergoing PTCA or PCI.
