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|April 28, 2015 8:31 a.m.|
|Teva Continues to Invigorate Injectable Portfolio with the Launch of Argatroban Injection in the United States|
Argatroban Injection works by blocking a certain natural substance (thrombin) that the body uses to form blood clots. This premixed formulation (250 mg in 250 mL aqueous sodium chloride solution) is supplied in a bag ready for intravenous infusion and does not require further dilution.
Argatroban Injection had annual sales of approximately
Teva is committed and focused on building a stronger generic injectable business globally. As the number one generics company in the world, we can quickly bring a range of high-quality, cost-effective generic injectable treatments to patients within the doctor’s office, hospital, or clinic. This month, Teva is also reintroducing Ondansetron Injection USP 40mg/20mL and Mesna Injection.
About Argatroban Injection in 0.9% Sodium Chloride
Argatroban Injection is indicated for prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT). Argatroban Injection is also indicated as an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI).
Important Safety Information
Argatroban is contraindicated in patients with major bleeding and in patients with a history of hypersensitivity to argatroban. Airway, skin, and generalized hypersensitivity reactions have been reported.
Hemorrhage can occur at any site in the body in patients receiving argatroban. An unexplained fall in hematocrit or hemoglobin or a fall in blood pressure should lead to consideration of a hemorrhagic event. Argatroban Injection should be used with extreme caution in disease states and other circumstances in which there is an increased danger of hemorrhage. Concomitant use of argatroban with antiplatelet agents, thrombolytics, and other anticoagulants may increase the risk of bleeding.
Use caution when administering argatroban to patients with hepatic impairment by starting with a lower dose and carefully titrating until the desired level of anticoagulation is achieved. Use of argatroban in PCI patients with clinically significant hepatic disease or AST/ALT levels ≥ 3 times the upper limit of normal should be avoided.
Anticoagulation effects associated with argatroban infusion at doses up to 40 mcg/kg/min correlate with increases of the activated partial thromboplastin time (aPTT). The concomitant use of argatroban and warfarin results in prolongation of the PT and INR beyond that produced by warfarin alone.
In clinical trials, the most common (> 5%) adverse reactions for HIT patients were dyspnea, hypotension, fever, diarrhea, sepsis, and cardiac arrest. The most common (> 5%) adverse reactions for PCI patients were chest pain, hypotension, back pain, nausea, vomiting and headache.
Please see accompanying Full Prescribing Information.
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