Safety and Tolerability Profile

Commitment to Safety 2

  • Pasteurized to inactivate viruses, with no confirmed cases of virus transmission.
    • Thrombate III is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses and, theoretically, the Creutzfeldt-Jakob agent that can cause disease.
  • The manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents. An individual production step in the Thrombate III manufacturing process has been shown to decrease TSE infectivity of that experimental model agent. The TSE reduction step is the Effluent I to Effluent II + III fractionation step (6.0 logs). These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.2
  • Thrombate III is a preparation of antithrombin concentrate purified from human plasma.

Tolerability

  • In clinical studies with Thrombate III, adverse reactions were reported in association with 17 of 340 infusions.2
  • The most common adverse events reported were dizziness, chest tightness, nausea, and foul taste in the mouth.2

Experience

  • Used for the treatment of Hereditary Antithrombin Deficiency for over 16 years.3

References:

  1. Data on file, Talecris Biotherapeutics, Inc.
  2. Thrombate III [prescribing information]. Research Triangle Park, NC: Talecris Biotherapeutics, Inc.; 2009.
  3. Scott GR, Robinson MJ, Wilczek J, Berson MR. FDA Drug and Device Product Approvals. Springfield, VA: Division of Drug Information Resources, OM, CDER, US Dept of Health and Human Services, Public Health Service; 1991;14(2):333.

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.