Pharmacokinetic study of minipooled solvent/detergent-filtered cryoprecipitate factor VIII

Eighteen cryoprecipitate minipools, each made of 30units of low volume, concentrated cryoprecipitate, have been treated by solvent-detergent and filtration (S/D-F) in a single-use CE-marked bag system. The S/D-F cryoprecipitate contained a mean of 10.5IUmL ^-1 factor VIII (FVIII), 17mgmL ^-1 clottable fibrinogen, and >10IUmL ^-1 von Willebrand factor ristocetin co-factor, and anti-A and anti-B isoagglutinins were undetectable. The products have been infused in 11 severe (FVIII -1. Patients were hospitalized for at least 36h to determine FVIII recovery, half-life and clearance. They were also closely monitored for possible adverse events. None of the infused patients demonstrated reactions or adverse events even though they did not receive anti-allergic drugs or corticosteroids prior to infusion. The mean recovery of FVIII 10min postinfusion was 69.7%. Mean FVIII half-life was 14.2h and clearance was 2.6mLh ^-1kg ^-1. All patients had a bleeding-free interval of 8-10days postS/D-F cryoprecipitate infusion. The data show that S/D-F cryoprecipitate FVIII presents a normal pharmacokinetics profile, and support that it could be safely used for the control of acute and chronic bleeding episodes in haemophilia A patients.