TY - JOUR
T1 - Continuous infusion of recombinant activated factor VII
T2 - A review of data in congenital hemophilia with inhibitors and congenital factor VII deficiency
AU - Rajpurkar, Madhvi
AU - Cooper, David L.
N1 - Funding Information:
Writing assistance was provided by Anna Abt, PhD, and Nicole Yohn, PhD, of ETHOS Health Communications, Yardley, Pennsylvania, with financial assistance from Novo Nordisk Inc., in compliance with international guidelines on Good Publication Practice.
Publisher Copyright:
© 2018 Rajpurkar and Cooper.
PY - 2018
Y1 - 2018
N2 - Introduction: Continuous infusion (CI) of clotting factors as a replacement therapy for peri-operative 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. Aim: To 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 methods: A 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. Results: The 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 postmarket-ing 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. Conclusion: rFVIIa CI has been performed safely and effectively in patients with CHwI and C7D undergoing surgery and during bleeding episodes in patients with CHwI.
AB - Introduction: Continuous infusion (CI) of clotting factors as a replacement therapy for peri-operative 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. Aim: To 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 methods: A 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. Results: The 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 postmarket-ing 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. Conclusion: rFVIIa CI has been performed safely and effectively in patients with CHwI and C7D undergoing surgery and during bleeding episodes in patients with CHwI.
KW - Bleeding
KW - Continuous infusion
KW - RFVIIa
KW - Surgery
UR - http://www.scopus.com/inward/record.url?scp=85065165169&partnerID=8YFLogxK
U2 - 10.2147/JBM.S184040
DO - 10.2147/JBM.S184040
M3 - Review article
AN - SCOPUS:85065165169
VL - 9
SP - 227
EP - 239
JO - Journal of Blood Medicine
JF - Journal of Blood Medicine
SN - 1179-2736
ER -