Thrombate III® Approved for Room Temperature Storage
Approval provides additional flexibility for hospitals
RESEARCH TRIANGLE PARK, N.C. (February 5, 2009) — Talecris Biotherapeutics announced today that Thrombate III [Antithrombin III (Human)], the plasma-derived antithrombin concentrate indicated for the treatment of hereditary antithrombin deficiency, can now be stored under room temperature conditions [not to exceed 25ºC (77ºF)] as approved by the Food and Drug Administration. The updated Prescribing Information for Thrombate III now reflects the new storage conditions.
In patients with hereditary antithrombin deficiency, Thrombate III prevents thromboembolism in high risk situations such as surgery, childbirth, and acute thromboembolism. It is pasteurized to inactivate viruses and purified to remove pro-inflammatory antibodies and cytokines. In more than 16 years of post-marketing history, there has never been a confirmed case of virus transmission. Thombate III is readily available in 500 I.U. vials from specialty distributors, and has been manufactured in ample supply since Talecris Biotherapeutics was formed in 2005.
Hereditary antithrombin deficiency affects 1:2000 to 1:5000 individuals in the United States, predisposing them to potentially life-threatening blood clots.
Important Safety Information
Thrombate III is indicated for the treatment of patients with hereditary antithrombin deficiency in connection with surgical or obstetrical procedures or when they suffer from thromboembolism.
In clinical studies with Thrombate III, the most common side effects were dizziness, chest tightness, nausea, and a foul taste in the mouth.
The anticoagulant effect of heparin is enhanced by concurrent treatment with Thrombate III in patients with hereditary AT-III deficiency. Thus, in order to avoid bleeding, reduced dosage of heparin is recommended during treatment with Thrombate III.
Thrombate III is made from human plasma. As with all plasma-derived therapeutics, the potential to transmit infectious agents, such as viruses and theoretically, the Creutzfeldt-Jakob (CJD) agent that can cause disease, cannot be totally eliminated. There is also the possibility that unknown infectious agents may be present in such products.
Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly hepatitis C.
Please see Thrombate III Full Prescribing Information for complete prescribing details.
About Talecris Biotherapeutics: Inspiration. Dedication. Innovation.
Talecris Biotherapeutics is a global biotherapeutic and biotechnology company that discovers, develops and produces critical care treatments for people with life-threatening disorders in a variety of therapeutic areas including immunology, neurology, pulmonology, and hemostasis. Talecris is proudly building upon a 60-year legacy of innovation and a commitment to improving the lives of people who rely on its therapeutic products. With an emphasis on scientific inquiry and technological excellence, Talecris is expanding its current portfolio of products, programs, and services through its own world-class product development organization as well as through strategic initiatives that leverage its strengths with those of its partners.
Talecris, with revenues of approximately $1.4 billion in 2008, is headquartered in biotech hub Research Triangle Park, N.C., and employs more than 4,500 talented people worldwide.
To learn more about Talecris and how its employees are making a difference in the lives of patients and the healthcare community, visit www.talecris.com.
Contact:
Wendy Wilson
Tel.: 919.316.2430, Fax: 919.316.6377
E-mail: wendy.wilson@talecris.com
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