What side effects are associated with the use of recombinant Factor VIIa?
  Recombinant Factor VIIa is very well tolerated. Experience with recombinant Factor VIIa in several thousand patients has shown that it is effective in the majority of cases (more than 90% in home treatment and elective orthopedic surgery), and that the number of serious adverse events is low (less than 1%). After administration of more than 185,000 standard doses of recombinant Factor VIIa as of July 2001 the most common serious adverse events reported predominantly in elderly patients, were thrombotic events. Consequently, care should be taken when administrating recombinant Factor VIIa to patients with known active arteriosclerotic disease or to patients with pathological conditions such as severe crush injury or septicemia, where TF expression may be increased above normal and disseminated intravascular coagulation is likely. Non-serious side effects are also rarely seen during treatment with recombinant Factor VIIa; the most common being pain at the infusion site, fever, headache, vomiting, changes in the blood pressure and skin-related hypersensitivity reactions.
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