Argatroban Injection, 50 mg per 50 mL†

Indications

Argatroban is a direct thrombin inhibitor indicated:

• For prophylaxis or treatment of thrombosis in adult patients with heparininduced
thrombocytopenia (HIT)

• As an anticoagulant in adult patients with or at risk of HIT undergoing percutaneous coronary intervention (PCI)

Important Safety Information

Argatroban is contraindicated in patients with:

• major bleeding

• history of hypersensitivity to Argatroban. Airway, skin, and generalized hypersensitivity reactions have been reported Hemorrhage at any site can occur (unexplained fall in hematocrit or blood pressure or other unexplained symptom may indicate hemorrhage). Use with caution in patients at risk, including those receiving antiplatelet agents, thrombolytics, or other anticoagulants as it may increase the risk of hemorrhage. Argatroban should be used with extreme caution in disease states or other circumstances in which there is an increased risk of hemorrhage. Caution should be exercised when administering  Argatroban to patients with hepatic impairment. Adjust starting dose and titrate carefully in patients with HIT who have moderate or severe hepatic impairment. Avoid use in PCI patients with clinically significant hepatic impairment. Anticoagulation effects associated with Argatroban infusion at doses up to 40 mcg/kg/min correlate with increases of the aPTT. Co-administration of Argatroban and warfarin results in a prolongation of PT and INR beyond that produced by warfarin alone. Overall major bleeding was reported in 5.3% of patients with HIT treated with Argatroban versus 6.7% of the historical controls in clinical trials. Major bleeding was reported in 1.8% of PCI patients with HIT treated with Argatroban versus 3.1% of the historical controls in clinical trials. In HIT patients, the most common non-hemorrhagic adverse reactions (>5%) were dyspnea, hypotension, fever, diarrhea, sepsis and cardiac arrest. In HIT patients undergoing PCI, the most common non-hemorrhagic adverse reactions (>%5) were chest pain, hypotension, back pain, nausea, vomiting and headache.

Please see the full Prescribing Information.   

†The Medicines Company has licensed the rights to market Argatroban Injection, 50 mg per 50 mL in the United States and Canada from Eagle Pharmaceuticals, Inc.