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 prophylaxis 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--ALL PATIENTS


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 in patients with hereditary antithrombin deficiency for treatment and prevention of thromboembolism and for prevention of perioperative and peripartum thromboembolism.

Hypersensitivity reactions may occur. Should evidence of an acute hypersensitivity reaction be observed, promptly interrupt the infusion and begin appropriate treatment.

Because THROMBATE III is made from human blood, it may carry a risk of transmitting infectious agents, eg, viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. There is also the possibility that unknown infectious agents may be present in the product.

Perform coagulation tests to avoid excessive or insufficient anticoagulation and monitor for bleeding or thrombosis. Measure functional plasma AT levels with amidolytic or clotting assays; do not use immunoassays.

In clinical studies, the most common adverse reactions (≥5% of subjects) were dizziness, chest discomfort, nausea, dysgeusia, and pain (cramps).

The anticoagulant effect of heparin is enhanced by concurrent treatment with THROMBATE III in patients with hereditary AT deficiency. Thus, in order to avoid bleeding, the dosage of heparin (or low molecular weight heparin) may need to be reduced during treatment with 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.