Octocog alfa, plasma/albumin-free method.

摘要

Octocog alfa, plasma/albumin-free method (octocog alfa-PFM) is a recombinant, human, full length, coagulation factor VIII that has been produced without the addition of human- or animal-derived plasma proteins, thereby virtually eliminating the risk of transmission of blood-borne pathogens. Octocog alfa-PFM is structurally and functionally very similar to a previously marketed, albumin-containing formulation of the same recombinant factor VIII. The haemostatic efficacy of octocog alfa-PFM was rated excellent or good in the acute treatment of most breakthrough bleeding episodes in adolescents or adults with moderately severe or severe haemophilia A who were receiving prophylaxis with octocog alfa-PFM and who had been previously treated with factor VIII. Most bleeding episodes resolved after one or two infusions of octocog alfa-PFM. Efficacy was similar regardless of the cause or site of the bleeding episode. Similar excellent or good haemostatic efficacy was observed with octocog alfa-PFM in previously treated children aged <6 years with haemophilia A and during perioperative use in patients with haemophilia A undergoing surgical or invasive dental procedures. Octocog alfa-PFM was well tolerated during clinical development and in the 15-month post-marketing period. There were very few adverse events and serious events were rare. The risk for developing inhibitors (antibodies) to factor VIII was very low.