Room-Temperature-Stable Recombinant Activated Coagulation Factor VII Recombinant: Chemical and Microbiologic Stability Over 24 Hours During Continuous In Vitro Infusion

Christensen, A J; Jensen, Jane Taaftegaard; Nøhr, Anne Mette; Cooper, David L.

doi:10.1016/j.clinthera.2011.10.023

Cited by 4 publications

(2 citation statements)

References 11 publications

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“…As noted by Pruthi et al, the planned dosage schedule precluded direct comparison of the required rFVIIa dose of CI vs BI 23. Previous investigation demonstrated the biochemical stability and maintenance of sterility of rFVIIa over 24 hours of CI when kept at room temperature, supporting the ability to infuse a constant dose over time 72. Our analysis aimed to summarize available safety, efficacy, and dosing data regarding CI of rFVIIa in patients with CHwI or C7D, and to compare CI outcomes to those of BIs, when available.…”

Section: Discussionmentioning

confidence: 97%

Continuous infusion of recombinant activated factor VII: a review of data in congenital hemophilia with inhibitors and congenital factor VII deficiency

Rajpurkar

Cooper

2018

JBM

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IntroductionContinuous infusion (CI) of clotting factors as a replacement therapy for perioperative hemostatic protection has been performed for many years, including with factors VIII and IX and recombinant activated factor VII (rFVIIa). This approach provides steady factor levels without requiring frequent administration of bolus doses.AimTo review safety, efficacy, and dosing data regarding CI of rFVIIa for hemostatic management of patients with congenital hemophilia with inhibitors (CHwI) or congenital factor VII deficiency (C7D).Materials and methodsA literature review identified instances of CI of rFVIIa in patients with CHwI or C7D undergoing surgery or experiencing bleeding episodes. Data regarding safety, efficacy, and dosing were extracted.ResultsThe safety and efficacy of 50 mcg/kg/h CI of rFVIIa following a 90 mcg/kg bolus injection, vs a standard bolus injection regimen, was reported for 24 patients with CHwI undergoing elective surgery in an open-label, randomized, Phase III trial. Efficacy was similar between CI and bolus injection groups at all postoperative time points assessed. Additionally, a postmarketing surveillance study reported effective (80%) and partially effective (20%) CI of rFVIIa in a Japanese cohort of ten patients with CHwI who underwent 15 surgical procedures. Finally, the safety and dosing of rFVIIa CI in 193 and 26 patients with CHwI and C7D, respectively, were reported in 11 prospective studies, 10 retrospective studies, and 30 case reports. No unexpected safety findings were reported.ConclusionrFVIIa CI has been performed safely and effectively in patients with CHwI and C7D undergoing surgery and during bleeding episodes in patients with CHwI.

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Section: Discussionmentioning

confidence: 97%

Continuous infusion of recombinant activated factor VII: a review of data in congenital hemophilia with inhibitors and congenital factor VII deficiency

Rajpurkar

Cooper

2018

JBM

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“…To generate a stable haemostatic plug, 90mcg/kg per rFVIIa bolus is required [5,6] . Evidence suggests the clinical activity and biochemical stability of rFVIIa is maintained after reconstitution over a 24-hour period up to 25°C, with no clinical complications [7,8,9] . The biochemical and microbiological stability of reconstituted rFVIIa has also been studied by Christensen et al in the context of continuous infusion, with no detectable microbiological growth (aerobic or anaerobic) found during 24-hour storage in a syringe at room temperature [7] .…”

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confidence: 99%

Use of an innovative syringe pump to deliver bolus rFVIIa for patients with haemophilia and inhibitors undergoing surgery

Pollard

Subel

Chowdary

et al. 2017

The Journal of Haemophilia Practice

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Aim: To evaluate the efficacy and safety of using a syringe driver perfusor pump to deliver frequent regular bolus doses of rFVIIa peri- and postoperatively to patients with severe haemophilia and inhibitors. Background: The provision of surgical haemostatic coverage with rFVIIa requires regular bolus doses, initially every two hours and subsequently three-hourly, moving to four- to six-hourly post-operatively. This has implications for safety and nursing time, and can influence clinical decision-making. We investigated the use of an infusion pump to deliver timed and accurate rFVIIa bolus doses during the postoperative period. Methods: Two patients with severe haemophilia A and inhibitors undergoing three procedures were managed with a pre-surgical bolus infusion of 120mcg/kg of rFVIIa, followed by postoperative doses of 90mcg/kg every two hours for the first 72 hours, and every three hours subsequently, with increasing dose intervals thereafter. All postoperative bolus doses were delivered via a pre-programmed infusion pump. The pump also required a constant background infusion set at 0.1ml/ hour for the first patient, and reduced to 0.01ml/hour for the second patient. Results: The pump was simple to use and readily accepted by patients and nursing staff. There were no delayed or missed doses, and good haemostasis was maintained. Overall nursing time involved in reconstituting and administering rFVIIa was reduced from three to six hours per treatment day (with conventional bolus dosing) to just one to two hours per day with the pump. Conclusions: The syringe pump successfully delivered the correct doses at the specified time intervals for all three procedures. The technique met the centre’s safety and efficacy criteria and resulted in a significant reduction in the amount of nursing time needed over a 24-hour period. This novel method of rFVIIa administration appears to be safe and effective in the elective surgery setting, and should be further investigated.

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Continuous infusion of rFVIIa during surgery in a FVII‐deficient patient: a case report from Japan

2013

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Room-Temperature-Stable Recombinant Activated Coagulation Factor VII Recombinant: Chemical and Microbiologic Stability Over 24 Hours During Continuous In Vitro Infusion

Cited by 4 publications

References 11 publications

Continuous infusion of recombinant activated factor VII: a review of data in congenital hemophilia with inhibitors and congenital factor VII deficiency

Continuous infusion of recombinant activated factor VII: a review of data in congenital hemophilia with inhibitors and congenital factor VII deficiency

Use of an innovative syringe pump to deliver bolus rFVIIa for patients with haemophilia and inhibitors undergoing surgery

Continuous infusion of rFVIIa during surgery in a FVII‐deficient patient: a case report from Japan

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