How Is Argatroban Supplied

Argatroban Injection is supplied in 2.5-mL solution in single-use vials at the concentration of 100 mg/mL. Each vial contains 250 mg of Argatroban.[2]

•	NDC 0007-4407-01 (Package of 1)

Stability/compatibility

Argatroban is a clear, colorless to pale yellow, slightly viscous solution.[2] If the solution is cloudy or if an insoluble precipitate is noted, the vial should be discarded.

Solutions prepared as recommended are stable at 25°C (77°F) (permitted range: 15°C to 30°C [59°F to 86°F]) in ambient indoor light for 24 hours; therefore, light-resistant measures such as foil protection for intravenous lines are unnecessary.[2]

Solutions are physically and chemically stable for up to 96 hours when protected from light and stored at controlled room temperature, 20°C to 25°C (68°F to 77°F) (see USP), or at refrigerated conditions, 5°C ± 3°C (41°F ± 5°F).

Prepared solutions should not be exposed to direct sunlight.

No significant potency losses have been noted following simulated delivery of the solution through intravenous tubing.

Indications
Argatroban is indicated as an anticoagulant for prophylaxis or treatment of thrombosis in patients with heparin-induced thrombocytopenia.

Argatroban is indicated as an anticoagulant in patients with or at risk for heparin-induced thrombocytopenia undergoing percutaneous coronary intervention (PCI).

Important Safety Information

As with all anticoagulants, bleeding is a serious concern. Argatroban is contraindicated in patients with overt major bleeding or those with hypersensitivity to the product or any of its components. Argatroban should be used with extreme caution in disease states or other circumstances in which there is an increased risk of hemorrhage. Overall major bleeding was reported in 5.3% of patients with HIT treated with Argatroban versus 6.7% of the historical controls. Overall major bleeding was reported in 1.8% of patients undergoing PCI treated with Argatroban versus 3.1% of the historical controls. Intracranial bleeding was not observed in the 568 patients treated with Argatroban for HIT (with or without thrombosis) or in the 91 patients who underwent PCI. The most common nonhemorrhagic side effects in HIT patients, regardless of the relationship to treatment, were dyspnea, hypotension, and fever. In patients undergoing PCI, the nonhemorrhagic side effects, regardless of the relationship to treatment, included chest pain, hypotension, and back pain. Please see full Prescribing Information for additional safety information on Argatroban.