What is the role of recombinant activated factor VIII (FVIII) the treatment of hemophilia A?

Updated: Jan 14, 2019
  • Author: Douglass A Drelich, MD; Chief Editor: Srikanth Nagalla, MBBS, MS, FACP  more...
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Answer

Recombinant activated FVII (FVIIa; Eptacog Alfa or NovoSeven) has become the first choice of bypassing agents. [36] Recombinant FVIIa is a vitamin K–dependent glycoprotein that is structurally similar to human plasma–derived FVIIa. [37] It is manufactured by using DNA biotechnology.

Intravenous recombinant FVIIa has been studied for the treatment of bleeding episodes and for providing hemostasis during surgery in patients with a particular bleeding diathesis. [36] Recombinant FVIIa is also effective and well tolerated in patients with acquired hemophilia and in those with Glanzmann thrombasthenia.

To date, recombinant activated FVIIa has proved to be relatively free of the risk of antigenicity, thrombogenicity, and viral transmission. However, the cost of this product and its short half-life have precluded its use as prophylaxis in patients with inhibitors for FVIII; furthermore, when it has been used for this indication, select patients have had severe complications related to bleeding.

In pediatric patients, off-label treatment with recombinant FVIIa significantly reduced blood product administration, with 82% of patients subjectively classified as responders. Clinical context and pH values before administration were independently associated with response and 28-day mortality. Thromboembolic adverse events were reported in 5.4% of patients. [38]


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