FDA approved Argatroban in Sodium Chloride for Thrombosis in HIT and PCIFDA approved new blood thinner for patients with rare clotting disorder.

FDA From the archive Source published November 27, 2018 Summary added June 13, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Consider argatroban for anticoagulation in HIT patients, with dosing and monitoring tailored to indication (HIT vs PCI).

The FDA has approved argatroban in sodium chloride injection (1 mg/mL) for prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT) and as an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI). Argatroban is a direct thrombin inhibitor that provides an alternative anticoagulation option for patients who cannot receive heparin due to HIT. The approval covers a ready-to-use formulation that does not require dilution, simplifying administration. Clinicians should note that dosing differs between HIT and PCI indications, and monitoring with aPTT (for HIT) or ACT (for PCI) is required to maintain therapeutic levels.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

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.

Indication & Patient Population

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).

Dosing & Administration

For HIT without hepatic impairment: initial dose 2 mcg/kg/min as continuous infusion; adjust to target aPTT 1.5-3 times baseline (not to exceed 100 seconds); maximum dose 10 mcg/kg/min. For PCI: initial infusion 25 mcg/kg/min plus bolus 350 mcg/kg over 3-5 minutes; target ACT 300-450 seconds; adjust per ACT results. Each 50 mL vial contains 50 mg argatroban (1 mg/mL) and is ready for IV infusion; no dilution required.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Argatroban in sodium chloride injection provides a direct thrombin inhibitor option for anticoagulation in patients with HIT, both for thrombosis prophylaxis/treatment and during PCI. Its ready-to-use formulation may offer convenience. Dosing and monitoring requirements differ by indication.

The FDA has approved a new medicine called Argatroban in Sodium Chloride injection. It is a blood thinner for adults with a condition called heparin-induced thrombocytopenia (HIT). HIT is a rare but serious reaction to the blood thinner heparin. In HIT, the body forms clots instead of preventing them. This new drug helps prevent or treat those clots. It can also be used during certain heart procedures to keep blood from clotting.

This approval is for a ready-to-use liquid form. That means it does not need to be mixed before use. This can make it easier for healthcare providers to give the medicine quickly. The drug works by blocking thrombin, a protein that helps blood clot. It is an option for patients who cannot take heparin because of HIT.

Doctors will need to monitor patients closely. For HIT, they will check a blood test called aPTT. For heart procedures, they will use a test called ACT. The dose is different for each use. This approval gives doctors and patients another choice for managing clotting risks.

If you or a loved one has HIT or needs a heart procedure, talk to your doctor. They can help decide if this new option is right for you. This approval does not mean the drug is right for everyone. Always follow your doctor's advice.

What this means for you:

New ready-to-use blood thinner approved for HIT; talk to your doctor if this applies to you.

Study Details

Study typeFda approval

PublishedNov 2018

View Original Abstract ↓

1 INDICATIONS AND USAGE Argatroban in sodium chloride injection is a direct thrombin inhibitor indicated: For prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT) (1.1) As an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI) (1.2) 1.1 Heparin-Induced Thrombocytopenia Argatroban in sodium chloride injection is indicated for prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT). 1.2 Percutaneous Coronary Intervention Argatroban in sodium chloride injection is indicated as an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI).

FDA approved Argatroban in Sodium Chloride for Thrombosis in HIT and PCIFDA approved new blood thinner for patients with rare clotting disorder.

Study Details

Biomarkers and clinical factors show statistical associations with sepsis-induced coagulopathy in 37,459 patients

Your Blood May Signal a Deadly Clotting Crisis Before It Strikes

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FDA approved Argatroban in Sodium Chloride for Thrombosis in HIT and PCIFDA approved new blood thinner for patients with rare clotting disorder.

Study Details

Biomarkers and clinical factors show statistical associations with sepsis-induced coagulopathy in 37,459 patients

Your Blood May Signal a Deadly Clotting Crisis Before It Strikes

Clinical research that matters. Delivered to your inbox.

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