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Full Prescribing Information

 

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Indications

Angiomax is a direct thrombin inhibitor indicated for use as an anticoagulant in patients:

• With unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA).

• Undergoing percutaneous coronary intervention (PCI) with provisional use of glycoprotein IIb/IIIa
   inhibitor (GPI) as in the REPLACE-2 study.

• With, or at risk of, heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia
   and thrombosis syndrome (HITTS), undergoing PCI.

Angiomax is intended for use with aspirin.

Limitation of use

Safety and effectiveness not established in patients with acute coronary syndromes who are not undergoing PTCA or PCI.

Important Safety Information

ANGIOMAX is intended for use with aspirin and has been studied only in patients receiving concomitant aspirin. ANGIOMAX is contraindicated in patients with active major bleeding or hypersensitivity to ANGIOMAX or its components. The most common (≥10%) adverse events for ANGIOMAX were back pain, pain, nausea, headache, and hypotension. 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. Please see complete prescribing information.