Events that increase the risk of thrombosis1,2


Surgery

  • Surgeries with a high risk for thrombosis include general, obstetric, orthopedic, oncologic, neurosurgery, cardiovascular, and gynecologic surgery
    • In 2 data series, the rate of thromboembolic complications in surgical patients with hereditary antithrombin (AT) deficiency ranged from 17% to 22%3,4*

Pregnancy and Childbirth

  • Up to 70% of pregnant women with hereditary AT deficiency who do not receive AT concentrate may experience thromboembolic complications2,5
    • Approximately 25% of these complications occur during delivery5
    • Half of the venous thromboembolism (VTE) episodes in these patients occur postpartum6

VTE POSTPARTUM


VTE risk is highest immediately after delivery7


Thromboembolism

  • More than 85% of patients with hereditary AT deficiency have suffered at least 1 thrombotic episode by age 502,4
    • 63% suffer recurrent episode4
    • 56% suffer pulmonary embolism4

 "The maintenance of normal blood
flow depends completely on the
inhibition of thrombin by antithrombin…" 8


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, the most common adverse events were dizziness, chest discomfort, nausea, and dysgeusia.

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. Plasma products carry a risk of transmitting infectious agents, such as viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent, despite steps designed to reduce this risk. No cases of transmission of viral disease or CJD have ever been identified for Thrombate III.

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


References

  1. Franchini M, Veneri D, Salvagno GL, Manzato F, Lippi G. Inherited thrombophilia. Crit Rev Clin Lab Sci. 2006;43(3):249-290.
  2. Thrombate III® (antithrombin III [human]) Prescribing Information. Grifols.
  3. Tengborn L, Bergqvist D. Surgery in patients with congenital antithrombin III deficiency. Acta Chir Scand. 1988;154(3):179-183.
  4. Pabinger I, Schneider B. Thrombotic risk in hereditary antithrombin III, protein C, or protein S deficiency. A cooperative, retrospective study. Gesellschaft fur Thrombose-und Hamostaseforschung (GTH) Study Group on Natural Inhibitors. Arterioscler Thromb Vasc Biol . 1996;16(6):742-748.
  5. 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.
  6. Patnaik MM, Moll S. Inherited antithrombin deficiency: a review. Haemophilia . 2008;14(6):1229-1239.
  7. Heit JA, Kobbervig CE, James AH, et al. Trends in the incidence of deep vein thrombosis and pulmonary embolism during pregnancy or the puerperium: a 30-year population-based study. Ann Intern Med. 2005;143:697-706.
  8. Li W, Johnson DJ, Esmon CT, Huntington JA. Structure of the antithrombin-thrombin-heparin ternary complex reveals the antithrombotic mechanism of heparin. Nat Struct Mol Biol . 2004;11(9):857-862.