Argatroban is a direct thrombin inhibitor indicated:

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For prophylaxis or treatment of thrombosis in adult patients with heparin induced thrombocytopenia (HIT). (1.1)

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As an anticoagulant in adults patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI). (1.2)

Argatroban Injection must be diluted 100-fold by mixing with 0.9% Sodium Chloride Injection, 5% Dextrose Injection or Lactated Ringer's Injection to a final concentration of 1 mg/mL. (2.1)

Heparin-Induced Thrombocytopenia

The dose for heparin-induced thrombocytopenia without hepatic impairment is 2 mcg/kg/min administered as a continuous infusion. (2.2)

Percutaneous Coronary Intervention

The dose for patients with or at risk for heparin-induced thrombocytopenia undergoing percutaneous coronary intervention is started at 25 mcg/kg/min and a bolus of 350 mcg/kg administered via a large bore intravenous line over 3 to 5 minutes. (2.3)

250 mg/2.5 mL single-dose vial. (3)

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Major bleeding. (4)

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History of hypersensitivity to this product. (4)

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Hemorrhage can occur. Unexplained fall in hematocrit or blood pressure may indicate hemorrhage. (5.1)

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Hepatic impairment: Adjust starting dose and titrate carefully in patients with HIT who have moderate or severe hepatic impairment. Avoid use in PCI in patients with clinically significant hepatic impairment. (5.2)

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HIT patients: The most common (> 5%) adverse reactions were dyspnea, hypotension, fever, diarrhea, sepsis, and cardiac arrest. (6)

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PCI patients: The most common (> 5%) adverse reactions were chest pain, hypotension, back pain, nausea, vomiting and headache. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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Heparin: Allow sufficient time for heparin's effect on activated partial thromboplastin time (aPTT) to decrease before initiating Argatroban Injection therapy. (7.1)

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Warfarin: Concomitant use results in increased prolongation of PT and INR. (7.2)

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Thrombolytic agents or glycoprotein IIb/IIIa antagonists: Safety and effectiveness of concomitant use with argatroban have not been established. (7.4, 7.5)

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Lactation: Discontinue nursing or drug, taking into account the importance of the drug to the mother. (8.2)

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Pediatric use: Safety and effectiveness have not been established. (8.4)