FDA Approves Argatroban in Sodium Chloride for Thrombosis in HIT and PCI

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

Argatroban in Sodium Chloride injection 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. Adjust dose (not to exceed 10 mcg/kg/min) to achieve aPTT 1.5 to 3 times baseline (not to exceed 100 seconds). Check aPTT 2 hours after initiation and after dose changes. For PCI: initial bolus 350 mcg/kg over 3-5 minutes and infusion 25 mcg/kg/min. Check ACT 5-10 minutes after bolus; target ACT 300-450 seconds. If ACT <300 seconds, give additional bolus 150 mcg/kg and increase infusion to 30 mcg/kg/min. If ACT >450 seconds, decrease infusion to 15 mcg/kg/min. Additional boluses and infusion increases up to 40 mcg/kg/min may be used for procedural complications. The product is ready to use; no dilution required.

Trial data not available in label.

Not reported in label.

Argatroban in Sodium Chloride injection provides a direct thrombin inhibitor option for anticoagulation in HIT patients, including those undergoing PCI. The ready-to-use formulation may simplify preparation. Dosing requires careful monitoring of aPTT (for HIT) or ACT (for PCI) to maintain therapeutic range.