Antithrombin III (AT III) is a blood protein that inhibits or stops the clotting factors in blood. Approximately 75% of the body's plasma coagulation inhibitory activity is derived from AT III.
AT III deficiency is a rare, inherited or spontaneously occurring condition that affects one in every 2,000 to 5,000 males and females worldwide. Individuals with this condition lack the AT III protein and spontaneous clotting can occur in the legs, arms, intestines, brain, kidney, eye, or other organs, such as the heart and lungs, as a result of normal, daily activity. In individuals with AT III deficiency, these clots can damage vital organs.
Thrombate III®, Antithrombin III (Human) is a sterile, nonpyrogenic, stable, lyophilized preparation of purified human antithrombin III (AT III).
US residents, refer to the WARNINGS section of the Thrombate III®, Antithrombin III (Human) package insert (PDF).
Important Safety Information Thrombate III, Antithrombin III (Human) 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 speak to your doctor and refer to the Thrombate Prescribing Information (PDF) 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.
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