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Full Prescribing Information
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Indication
Angiomax® (bivalirudin) for Injection is a direct thrombin inhibitor indicated for use as an anticoagulant in patients:
• Undergoing percutaneous coronary intervention (PCI) with provisional use of glycoprotein IIb/IIIa inhibitor (GPI);
• With, or at risk of, heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis syndrome (HITTS), undergoing PCI; and
• With unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA).
Angiomax is intended for use with aspirin and has been studied only in patients receiving concomitant aspirin. The safety and effectiveness of Angiomax have not been established in patients with acute coronary syndromes (ACS) who are not undergoing PCI or PTCA.
Important Safety Information
Angiomax® (bivalirudin) for Injection is contraindicated in patients with active major bleeding and hypersensitivity (e.g., anaphylaxis) to Angiomax or any of its components.
Hemorrhage can occur at any site. An unexplained fall in blood pressure or hematocrit, or any unexplained symptom, should lead to serious consideration of a hemorrhagic event and cessation of Angiomax administration. Angiomax should be used with caution in patients with disease states associated with an increased risk of bleeding.
Acute stent thrombosis (AST) (<4 hours) has been observed at a greater frequency in Angiomax treated patients compared to heparin treated patients with ST segment elevation myocardial infarction (STEMI) undergoing primary PCI. Among patients who experienced an AST, one fatality (0.03%) occurred in an Angiomax treated patient and one fatality (0.03%) in a heparin treated patient. These patients have been managed by Target Vessel Revascularization (TVR). Patients should remain for at least 24 hours in a facility capable of managing ischemic complications and should be carefully monitored following primary PCI for signs and symptoms consistent with myocardial ischemia.
In gamma brachytherapy, an increased risk of thrombus formation, including fatal outcomes, has been associated with the use of Angiomax.
INR measurements made in patients who have been treated with Angiomax may not be useful for determining the appropriate dose of warfarin. The most common adverse reaction for Angiomax was bleeding (28%). Other adverse reactions (>0.5%) for Angiomax were headache, thrombocytopenia, and fever.
Please see complete
prescribing information for Angiomax.