Prescribing Information

This prescribing information is intended for international use only. Please always consult your full country-specific prescribing information/summary of product characteristics as licenses and licensing conditions may vary from country to country.

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Important Safety Information

FEIBA must not be used in the following situations if therapeutic alternatives to FEIBA are available:

  • Hypersensitivity to the product or any of the components.
  • Disseminated Intravascular Coagulation (DIC).
  • Acute thrombosis or embolism (including myocardial infarction).

Thrombotic and thromboembolic events, including disseminated intravascular coagulation (DIC), venous thrombosis, pulmonary embolism, myocardial infarction, and stroke have occurred in the course of treatment with FEIBA, particularly after administration of doses above the maximum daily dose and/or prolonged application or in patients with other risk factors for thromboembolic events.
As with any intravenously administered plasma product, allergic type hypersensitivity reactions may occur; patients should be informed of the early signs of hypersensitivity reactions. When medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. This also applies to any unknown or emerging viruses or other types of infections.
Administration of FEIBA to patients with inhibitors may result in an initial anamnestic rise in inhibitor levels. Upon continued administration of FEIBA, inhibitors may decrease over time. Clinical and published data suggest that the efficacy of FEIBA is not reduced.