Stability of ADVATE, Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method, during simulated continuous infusion
- 1 April 2006
- journal article
- research article
- Published by Ovid Technologies (Wolters Kluwer Health) in Blood Coagulation & Fibrinolysis
- Vol. 17 (3), 165-171
- https://doi.org/10.1097/01.mbc.0000220236.92219.08
Abstract
Continuous infusion of factor VIII (FVIII) concentrates during surgical procedures offers the potential for improved hemostatic control and reduced FVIII consumption, but requires stable FVIII concentrates. The stability of ADVATE, Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method (rAHF-PFM), was examined using various simulated conditions. Experiments performed with a multi-therapy 6060 pump showed FVIII recoveries of 95% or more after 48 h for multiple lots of high-potency and mid-potency rAHF-PFM, with or without heparin. Non-infused controls maintained at the same temperature showed similar FVIII recovery, demonstrating that the infusion system did not cause loss of FVIII activity. Supportive data generated using single lots of mid-potency or high-potency rAHF-PFM infused through a MEDEX or HARVARD syringe pump, or a CADD Pump-1, demonstrated FVIII recoveries of 83% or more at 24 or 48 h under all conditions tested. Additionally, rAHF-PFM was stable immediately after dilution in saline or saline/dextrose solutions, and after a 10-h exposure to ultraviolet and visible light. Taken together, these data demonstrate that rAHF-PFM is stable under conditions typically encountered during continuous infusion, and suggest that rAHF-PFM should be safe and effective when used for FVIII replacement by continuous infusion in patients with hemophilia A.Keywords
This publication has 29 references indexed in Scilit:
- Clinical evaluation of an advanced category antihaemophilic factor prepared using a plasma/albumin‐free method: pharmacokinetics, efficacy, and safety in previously treated patients with haemophilia A1Haemophilia, 2004
- Clinical evaluation of B-domain deleted recombinant factor VIII in previously treated patientsSeminars in Hematology, 2001
- In vitro stability of recombinant human factor VIII (Recombinate™)Haemophilia, 2000
- Homozygosity for R87H missense mutation and for a rare intron 7 DNA variant (7054G???A) in the PROC genes of three siblings initially classified as heterozygotes for protein C deficiencyBlood Coagulation & Fibrinolysis, 1996
- Stability of factor VIII preparation in continuous infusionAnnals of Hematology, 1994
- Stability of factor VIII concentrates after reconstitutionAmerican Journal of Hematology, 1994
- Adjusted dose continuous infusion of factor VIII in patients with haemophilia ABritish Journal of Haematology, 1992
- Continuous infusion of monoclonal antibody-purified factor VIIIAmerican Journal of Hematology, 1991
- The use of continuous infusion of factor concentrates in the treatment of hemophiliaAmerican Journal of Hematology, 1989
- Continuous Intravenous Infusion of Factor VIII in Classic HaemophiliaBritish Journal of Haematology, 1970