A review of current literature on second-generation, sucrose-formulated, full-length recombinant factor VIII.
Recombinant factor VIII formulated with sucrose (rFVIII-FS) is a full-length recombinant human coagulation FVIII product which is formulated without the addition of human serum albumin. It is approved for the treatment and prophylaxis of bleeding events in patients with hemophilia A in various countries including the U.S. and the E.U. In substitution therapy, rFVIII-FS is well tolerated by patients who lack FVIII, including patients undergoing major surgery. To date there are no head-to-head studies evaluating the therapeutic profile of rFVIII-FS in comparison to other octocog or morocog alfa products. However, available data of noncomparative trials, with a favorable safety profile, indicate that rFVIII-FS is a viable alternative to other FVIII products for the treatment and prophylaxis of bleeding episodes in patients with hemophilia A.
Konigs
Christoph
C
Molecular Hemostasis and Immunodeficiencies, Department of Paediatrics, Medical Centre of Johann Wolfgang Goethe University, Frankfurt am Main, Germany. Hentig@em.uni-frankfurt.de.
von Hentig
Nils
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D000818:Animals; D002986:Clinical Trials as Topic; D004353:Drug Evaluation, Preclinical; D005079:Excipients / Q000737:chemistry; D005169:Factor VIII / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D006467:Hemophilia A / Q000150:complications / Q000188:drug therapy*; D006470:Hemorrhage / Q000517:prevention & control; D006801:Humans; D013395:Sucrose / Q000737:chemistry*
D005079:Excipients; D013395:Sucrose; C078147:F8 protein, human; D005169:Factor VIII