Continuous infusion of porcine factor VIII: stability, microbiological safety and clinical experience.
Porcine factor VIII (pFVIII) is an effective haemostatic treatment for bleeding in selected patients with FVIII inhibitors. Its use is sometimes associated with a transient fall in platelet count and transfusion reactions, the risk of which may be related to the rate of administration. Theoretical considerations suggest that the administration of pFVIII by continuous infusion should be effective, and could have pharmacokinetic advantages that lead to an improvement in the side-effect profile. The results of a retrospective survey of continuous infusion of pFVIII with respect to clinical safety and efficacy are reported. Porcine FVIII stability and microbiological studies are included. It is concluded that pFVIII given by continuous infusion is safe and effective. The risk of transfusion reactions and fall in platelet count appears to be reduced, compared with bolus administration. Stability studies showed that pFVIII activity declined at room temperature, most rapidly in the dilute solution (5-10 U mL(-1)). More concentrated mixtures showed acceptable stability for up to 24 h using a variety of infusion devices. Various concentrations of pFVIII did not support the growth of Escherichia coli or Staphylococcus aureus. These observations suggest that the porcine factor is suitable for continuous infusion (CI).
DiMichele
D M
DM
Regional Comprehensive Hemophilia Diagnostic and Treatment Center, New York Presbyterian Hospital-Weill Medical College of Cornell University, 525 East 68th Street,Room P-695, New York, NY 10021, USA. dmdimich@med.cornell.edu
Gorman
P O
PO
Kasper
C K
CK
Mannucci
P M
PM
Santagostino
E
E
Hay
C R M
CR
D000293:Adolescent; D000328:Adult; D000818:Animals; D001419:Bacteria / Q000254:growth & development; D002648:Child; D002675:Child, Preschool; D003257:Consumer Product Safety; D003625:Data Collection; D004355:Drug Stability; D005169:Factor VIII / Q000008:administration & dosage* / Q000592:standards; D006467:Hemophilia A / Q000150:complications / Q000188:drug therapy; D006801:Humans; D007223:Infant; D007263:Infusions, Parenteral / Q000009:adverse effects / Q000379:methods / Q000592:standards; D013552:Swine; D013810:Therapeutic Equivalency
D005169:Factor VIII