Indication

Thrombate III is indicated for patients with hereditary AT deficiency in connection with surgical or obstetrical procedures or when they suffer from thromboembolism.¹

Thrombate III Efficacy

In a clinical study, Thrombate III prevented thromboembolism in high-risk situations

In clinical trials, patients with documented hereditary AT deficiency and histories of thromboembolism were given Thrombate III, administered either prophylactically to prevent thromboembolism during high-risk procedures or therapeutically to treat existing thromboembolism.

Patients were treated with an initial loading dose to increase plasma AT levels to 120% of normal. Once predictable peak and trough levels were achieved, infusions of 60% of the initial loading dose were administered every 24 hours to maintain plasma AT levels of 70% to 120% of normal.²

Adapted from Thrombate III Prescribing Information.¹

a. Data included 13 patients treated on 16 separate occasions (11 surgical procedures and 5 deliveries).² One patient was treated on separate occasions for surgery and childbirth.¹ Heparin was administered in 3 of 11 surgical procedures and in all 5 deliveries. Patients received an initial loading dose of antithrombin concentrate to increase plasma levels to 120%, followed by maintenance doses of 60% of the initial loading dose every 24 hours to maintain plasma antithrombin levels between 70% and 120%.^1,2 Prior to receiving Thrombate III, patients in the study had an average baseline antithrombin level of 53% (range from 22-71%).³

b. All patients received heparin.

c. One patient died of nontreatment-related causes.

References:

Thrombate III [prescribing information]. Research Triangle Park, NC: Talecris Biotherapeutics, Inc.; 2009.
Schwartz RS, Bauer KA, Rosenberg RD, Kavanaugh EJ, Davies DC, Bogdanoff DA; the Antithrombin III Study Group. Clinical experience with antithrombin III concentrate in treatment of congenital and acquired deficiency of antithrombin. Am J Med. 1989;87(suppl 3B):53S-60S.
Data on file, Talecris Biotherapeutics, Inc.

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.