FDA Approves Argatroban for Thrombosis in Heparin-Induced Thrombocytopenia

Argatroban is a direct thrombin inhibitor that reversibly binds to the thrombin active site. It inhibits thrombin-catalyzed reactions, including fibrin formation, activation of coagulation factors V, VIII, and XIII, and platelet aggregation.

Argatroban is indicated for prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT). It is also indicated as an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI).

For HIT without hepatic impairment: initial dose 2 mcg/kg/min as continuous infusion, adjusted to achieve aPTT 1.5-3 times baseline (not to exceed 100 seconds). Maximum dose 10 mcg/kg/min. For PCI: initial bolus 350 mcg/kg over 3-5 minutes plus infusion 25 mcg/kg/min; target ACT >300 seconds. Argatroban must be diluted to 1 mg/mL before use (250 mg/2.5 mL vial) or used as ready-to-infuse 50 mg/50 mL solution.

Trial data not available in label.

Not reported in label.

Argatroban provides a direct thrombin inhibitor option for anticoagulation in HIT patients, both for medical management of thrombosis and during PCI. It is an alternative to heparin in patients with HIT.