The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
As an anticoagulant in conjunction with aspirin
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
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
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
- back pain