Vaskulárna medicína 1/2018
Idelvion (Albutrepenonacog Alfa) − rekombinantný koagulačný faktor IX s predĺženým účinkom v liečbe hemofílie B
Idelvion (Albutrepenonacog Alfa) – recombinant coagulation factor IX with prolonged effect in the treatment of hemophilia B
Currently, we have in the treatment of hemophilia B in addition to plasma coagulation factors and new recombinant FIX (rFIX) albutrepenonakog alpha (Idelvion, CSL Behring, Marburg, Germany). It is a fusion protein (FP) that binds rFIX to recombinant human albumin (rAlbumine), thus allowing for a prolongation of the elimination half-life of rIX-FP in the blood. Due to the prolonged half-life can be used as a prophylactic regimen 7-14 days. This article describes the results of the published PROLONG-9FP study that looked at the pharmacological properties and clinical use of rIX-FP. In the phase III clinical trial in previously treated patients with moderate or severe haemophilia B, as a prophylactic regimen (administered once every 7 days for children and every 7-14 days for adolescents and adults) was recorded in rFIX-FP reduced annual incidence of spontaneous bleeding episodes. The use of rIX-FP was also effective in treating bleeding episodes in haemophilia B patients with on demand treatment and in maintaining hemostasis during the perioperative period. In clinical studies, rIX-FP was well tolerated, with no evidence of inhibitor incidence. Clinical use of rIX-FP provides an effective, well-tolerated treatment management option for hemophilia B, which, due to prolonged half-life, is less burdensome than the FIX-based plasma preparations.
Keywords: hemophilia B, factor IX, prolonged biological half-life, fusion protein, PROLONG-9FP
