Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) announces the launch of Argatroban Injection in 0.9% sodium chloride, 250 mg/250 mL for intravenous infusion only, in the United States. Argatroban Injection is used to prevent or treat blood clots in adult patients who have developed antibodies to heparin or heparin-like products causing a decrease in platelets (known as heparin-induced thrombocytopenia). Argatroban Injection is also used as a blood thinner in adult patients during percutaneous coronary intervention (PCI), a cardiac procedure, in patients who have had or are at risk for heparin-induced thrombocytopenia.
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 $22 million in the United States, according to IMS data as of December 2014.
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.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and
TASE: TEVA) is a leading global pharmaceutical company that delivers
high-quality, patient-centric healthcare solutions to millions of
patients every day. Headquartered in Israel, Teva is the world’s largest
generic medicines producer, leveraging its portfolio of more than 1,000
molecules to produce a wide range of generic products in nearly every
therapeutic area. In specialty medicines, Teva has a world-leading
position in innovative treatments for disorders of the central nervous
system, including pain, as well as a strong portfolio of respiratory
products. Teva integrates its generics and specialty capabilities in its
global research and development division to create new ways of
addressing unmet patient needs by combining drug development
capabilities with devices, services and technologies. Teva's net
revenues in 2014 amounted to $20.3 billion. For more information, visit www.tevapharm.com.
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Teva Pharmaceutical Industries Ltd.
IR:
Kevin C. Mannix, 215-591-8912
United States
or
Tomer Amitai, 972 (3) 926-7656
Israel
or
Ran Meir, 215-591-3033
United States
or
PR:
Iris Beck Codner, 972 (3) 926-7687
Israel
or
Denise Bradley, 215-591-8974
United States