Usage of Thrombate III

Use Thrombate III for Patients With Hereditary Antithrombin Deficiency
in High-risk Situations.

  • Surgeries with a high risk for thrombosis include orthopedic, oncologic, general, neurosurgery, and gynecologic surgery.1 In general, patients who develop in-hospital clinical venous thromboembolism (VTE) following major orthopedic surgery have significantly longer hospital stays and incur approximately two-fold higher inpatient care costs2
  • Childbirth. The incidence of thromboembolic complications among pregnant women with hereditary antithrombin deficiency may be as high as 70%3
  • Thromboembolism. Approximately 85% of patients with hereditary antithrombin deficiency have had at least one thrombotic episode by age 50, and approximately 60% may have recurrent episodes4
    • Antithrombin concentrate is targeted to prevent the expansion of a formed clot and formation of additional thrombi

References:

  1. Gutt CN, Oniu T, Wolkener F, Mehrabi A, Mistry S, Büchler MW. Prophylaxis and treatment of deep vein thrombosis in general surgery. Am J Surg. 2005;189:14–22.
  2. Ollendorf DA, Vera-Llonch M, Oster G. Cost of venous thromboembolism following major orthopedic surgery in hospitalized patients. Am J Health Syst Pharm. 2002;59(18):1750-1754.
  3. Hellgren M, Tengborn L, Abildgaard U. Pregnancy in women with congenital antithrombin III deficiency:
    experience of treatment with heparin and antithrombin. Gynecol Obstet Invest. 1982;14(2):127-141.
  4. Thaler E, Lechner K. Antithrombin lll deficiency and thromboembolism. Clin Haematol. 1981;10(2):369-390.

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 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. Products made from human plasma may contain infectious agents, such as viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent that can cause disease. There is also the possibility that unknown infectious agents may be present in such products.

Individuals who receive infusions of blood or blood plasma may develop signs and/or symptoms of some viral infections, particularly hepatitis C.

Please speak to your doctor and refer to Thrombate III Prescribing Information for full details.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.