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Full Prescribing Information

 

Global Health Science Center

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Product Overview

Angiomax® (bivalirudin) 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

• 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 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.

In gamma brachytherapy, an increased risk of thrombus formation, including fatal outcomes, has been associated with the use of Angiomax.

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.