Eagle argatroban is a single-use vial, containing 50 mg of drug in a 50 mL aqueous solution (1 mg/mL).8 The vial incorporates an IV pole ring sling for convenience during administration.

Indications

  • For prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT)8
  • As an anticoagulant in adult patients with or at risk of HIT undergoing percutaneous coronary intervention (PCI)8

Our partners, The Medicines Company and Sandoz, currently market argatroban in the U.S. To report product quality concerns or drug safety issues, including adverse events, please contact the company listed on the box:

For full Prescribing Information please see the package insert.

Limitations of Other Argatroban Treatments (250 mL)

  • Requires dilution for infusion by hospital pharmacist, introducing the potential for dosing errors14
  • Significant drug waste of approximately 30% occurs with 250 mL argatroban5

Eagle’s Answer

  • Ready-to-use vial does not require any dilution8
  • 50 mg of drug in a 50 mL aqueous solution in a single-use vial8
  • Significant reduction in drug waste (total drug waste approximately 1%)5
  • IV pole ring sling for convenient administration

Important Safety Information

Contraindications

  • 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.

In clinical trials, major bleeding was reported in 1.8% of patients treated with argatroban with or at risk of HIT undergoing PCI.

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.