Generic Argatroban Injection Launched in US

Teva has launched generic argatroban injection in 0.9% sodium chloride for cardiac event prophylaxis or treatment in adult patients in the United States with heparin-induced thrombocytopenia (HIT).

The injectable drug is indicated to prevent or treat thrombosis in adult HIT patients and also serve as an anticoagulant during percutaneous coronary intervention (PCI) in those with or at risk for HIT.

The premixed argatroban injection 250 mg in 250 mL aqueous sodium chloride solution is supplied in a bag prepared for intravenous infusion without any need for further dilution.

Argatroban is contraindicated in patients with major bleeding and those with a history of hypersensitivity to the drug. Concomitant use with antiplatelet agents, thrombolytics, and other anticoagulants may increase the risk of bleeding.

When administering argatroban to patients with hepatic impairment, clinicians are advised to use caution by starting with a lower dose and carefully titrating until the desired level of anticoagulation is achieved.

In clinical trials, the most common adverse reactions were dyspnea, hypotension, fever, diarrhea, sepsis, and cardiac arrest for HIT patients, and chest pain, hypotension, back pain, nausea, vomiting, and headache for PCI patients.

As of December 2014, argatroban injection had annual US sales of approximately $22 million, according to IMS data.