Angiomax (bivalirudin) is indicated as a thrombin-specific anticoagulant to be used in conjunction with aspirin in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA). It is available by prescription only in a 250mg injectable formulation. The drug has been studied only in patients receiving concomitant aspirin.
Double-blinded clinical trials involving 4,312 patients undergoing PTCA for new onset angina, accelerating episodes of angina, or angina at rest were conducted to test the effectiveness and safety of the product in clinical outcomes compared to heparin. The data demonstrated significant improvement compared to heparin—the current standard anticoagulant used in PTCA.
The FDA approved product labeling includes clinical data showing a 22% reduction in the risk of death, myocardial infarction (MI) or revascularization for ANGIOMAX-treated patients (6.2%) compared with heparin-treated patients (7.9%). The difference was sustained at 90-days and 6-months. In the same trial data, Angiomax also demonstrated a 62% reduction in the incidence of major hemorrhage for ANGIOMAX-treated patients (3.5%) compared to heparin-treated patients (9.3%). These significantly lower incidence rates of clinically important events following angioplasty translated into 68 fewer patients experiencing adverse and costly outcomes for every 1,000 patients treated. (From Company Press Release)
Angiomax is contraindicated in patients with active major bleeding or hypersensitivity to the drug or its components. Angiomax is not intended for intramuscular administration. Although most bleeding associated with the use of Angiomax in PTCA occurs at the site of arterial puncture, hemorrhage can occur at any site.
The safety and effectiveness of ANGIOMAX have not been established in patients with unstable angina who are not undergoing PTCA or in patients with other acute coronary syndromes. Additionally, the safety and effectiveness of ANGIOMAX have not been established when used in conjunction with platelet inhibitors other than aspirin, such as glycoprotein (GP)IIb/IIIa inhibitors. However, drug-drug interaction studies have been conducted with the ADP antagonist, ticlopidine, and the GPIIb/IIIa inhibitor, abciximab, and with low molecular weight heparin. Although data are limited, thus precluding conclusions regarding efficacy and safety in combination with these agents, the results show no evidence of pharmacodynamic interactions. (From Company Press Release) The most common side effects associated with Angiomax include, but are not limited to: