Hereditary antithrombin (AT) deficiency treatment

THROMBATE III antithrombin III [human] packaging image

THROMBATE III is a human antithrombin indicated in patients with hereditary AT deficiency (HATD), an inherited clotting disorder, for1:

  • Treatment and prevention of thromboembolism
  • Prevention of perioperative and peripartum thromboembolism

THROMBATE III prevents and treats thromboembolism in patients with HATD during high-risk situations, including pregnancy and childbirth.1,2


Antithrombin (AT) and venous thromboembolism (VTE) risk

Each year, more than 250,000 patients are hospitalized for VTE in the United States.3 This emphasizes the importance of assessing VTE risk in patients.

Even modest decreases in AT levels significantly increase VTE risk4

  • The risk of unprovoked VTE is 6 times higher for those with AT levels between 61% and 75%4

Hereditary AT deficiency (HATD)

Presents the highest risk of thrombosis among inherited thrombophilias5

  • HATD affects 1 in every 500 to 5000 individuals1,6,7
  • Those with HATD have a 20-fold greater risk of thrombosis than the general population5

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Efficacy of THROMBATE III

THROMBATE III is an effective choice in high-risk situations1

Clinical studies have shown that THROMBATE III is an effective choice for patients with HATD and for the treatment and prevention of thromboembolism, including before, during, and after surgery and childbirth.1

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Simplicity of THROMBATE III

In clinical use, THROMBATE III:

Has no known contraindications1

Has a low risk of major bleeding complications, even in the presence of heparin (enoxaparin)1

Is effective in high-risk situations, including surgery, pregnancy, and childbirth

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.

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Convenience of THROMBATE III

THROMBATE III is simple to use

With THROMBATE III, experience the convenience of one dosing formula1:

  • Bolus intravenous infusion
  • Predictable dosing that directly replaces missing AT

THROMBATE III is also convenient to store and reconstitute

AT and the coagulation cascade

AT activity inhibits many clotting factors in the coagulation cascade8-12

The inhibition of multiple clotting factors by AT helps prevent the expansion of existing clots and the formation of new clots in 3 stages:

Procoagulation factors bind to AT

Once bound to AT, procoagulation factors are cleared

This results in arresting the growth of existing clots and helps prevent new clots

The anticoagulation effects of heparin rely entirely on its interaction with AT7

The administration of heparin increases the anticlotting effects of AT 1000-fold.7-9,13

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IMPORTANT SAFETY INFORMATION


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.

Please see full Prescribing Information 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. THROMBATE III® (antithrombin III [human]) Prescribing Information. Grifols. 2. Heit JA, Kobbervig CW, James AH, Petterson TM, Bailey KR, Melton LJ. Ann Intern Med. 2005;143:697-706. 3. Lloyd-Jones D, Adams RJ, Brown TM, et al; on behalf of the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2010;121:e46-e215. 4. Bucciarelli P, Passamonti SM, Biguzzi E, et al. J Thromb Haemost. 2012;10:1783-1791. 5. Franchini M, Veneri D, Salvagno GL, Manzato F, Lippi G. Crit Rev Clin Lab Sci. 2006;43(3):249-290. 6. Wells PS, Blajchman MA, Henderson P, et al. Am J Hematol. 1994;45:321-324. 7. Patnaik MM, Moll S. Haemophilia. 2008;14(6):1229-1239. 8. Maclean PS, Tait RC. Drugs. 2007;67(10):1429-1440. 9. Li W, Johnson DJ, Esmon CT, Huntington JA. Nat Struct Mol Biol. 2004;11(9):857-862. 10. James AH, Konkle BA, Bauer KA. Int J Womens Health. 2013;5:233-241. 11. Davi G, Patrono C. N Engl J Med. 2007;357(24):2482-2494. 12. Wolberg AS. Blood Rev. 2007;21(3):131-142. 13. Kottke-Marchant K, Duncan A. Arch Pathol Lab Med. 2002;126(11):1326-1336.