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Pharmacokinetic study of minipooled solvent/detergent‐filtered cryoprecipitate factor VIII
Author(s) -
ELEKIABY M.,
GOUBRAN H. A.,
RADOSEVICH M.,
ABDALLAH A.,
ELEKIABY A.,
BURNOUF T.
Publication year - 2011
Publication title -
haemophilia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.213
H-Index - 92
eISSN - 1365-2516
pISSN - 1351-8216
DOI - 10.1111/j.1365-2516.2011.02511.x
Subject(s) - cryoprecipitate , medicine , pharmacokinetics , haemophilia a , adverse effect , haemophilia , gastroenterology , fibrinogen , urology , surgery
Summary. Eighteen cryoprecipitate minipools, each made of 30 units 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 10.5 IU mL −1 factor VIII (FVIII), 17 mg mL −1 clottable fibrinogen, and >10 IU mL −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%) haemophilia A patients (mean age: 17.4 years; mean weight: 57.6 kg) at a dose close to 40 IU kg −1 . Patients were hospitalized for at least 36 h 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 10 min postinfusion was 69.7%. Mean FVIII half‐life was 14.2 h and clearance was 2.6 mL h −1 kg −1 . All patients had a bleeding‐free interval of 8–10 days 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.