Description of Thrombate III

Thrombate III is a preparation of antithrombin concentrate purified from human plasma. It is prepared from pooled units of human plasma, from normal donors by modifications and refinements of the cold ethanol method of Cohn. When reconstituted with Sterile Water for Injection, USP, Thrombate III has a pH of 6.0-7.5, a sodium content of 110-210 mEq/L, a chloride content of 110-210 mEq/L, an alanine content of 0.075-0.125 M, and a heparin content of not more than 0.004 unit/IU AT-lll.¹
Thrombate III is administered by intravenous dose.¹
Thrombate III contains no preservative.¹
Thrombate III has been heat-treated in solution at 60^oC ± 0.5^oC for not less than 10 hours.¹
Each vial of Thrombate III contains the labeled amount of AT in international units (IU) per vial. The potency assignment has been determined with a standard calibrated against a World Health Organization AT reference preparation.¹ Convenient vial size minimizes waste.
Thrombate III has a half-life similar to endogenous antithrombin.¹
Bolus intravenous infusion (over 10-20 minutes).¹
Thrombate III should be stored at room temperature - no refrigeration required.¹

Importance of Antithrombin (AT)

AT, synthesized in the liver, is the major serine protease inhibitor (serpin) of coagulation and essential for hemostasis.²

AT is responsible for approximately 80% of the plasma inhibition of thrombin and limits the size of the hemostatic plug formed under normal physiologic conditions.²

Individuals deficient in AT are at increased risk of thromboembolism, the formation of an obstructive thrombus (clot), most commonly in the venous system.^3-5

References:

Thrombate III [prescribing information]. Research Triangle Park, NC: Talecris Biotherapeutics, Inc.; 2009.
Perry DJ. Antithrombin and its inherited deficiencies. Blood Rev. 1994;8(1):37-55.
Franchini M, Veneri D, Salvagno GL, Manzato F, Lippi G. Inherited thrombophilia. Crit Rev Clin Lab Sci. 2006;43(3):249-290.
Bucur SZ, Levy JH, Despotis GJ, Spiess BD, Hillyer CD. Use of antithrombin III concentrate in congenital and acquired deficiency states. Transfusion. 1998;38(5):481-498.
Rosendaal FR, Van Hylckama Vlieg A, Doggen CJ. Venous thrombosis in the elderly. J Thromb Haemost. 2007;5(suppl 1):310-317.

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.