FEIBA is an integral part of inhibitor therapy management

No single agent works in all patients or in all bleeds

The FENOC study (FEIBA NovoSeven Comparative Study) was the first to evaluate the use of bypassing agents in inhibitor patients comparatively. These data are of significance to the treating community.

The FENOC study was a prospective, open-label, randomised, multicenter, crossover study to determine the equivalence of one dose of FEIBA with two doses of rFVIIa1

The FENOC study shows that an inhibitor patient's response can vary.

  • Hemostatic responses to FEIBA and rFVIIa were found to be comparable overall but individual responses were variable1
  • It can be difficult to predict a patient's therapy response to any bleed:
    • The proportion of variable responses (one therapy effective/the other not effective) were reported to be as high as 43.8%1
  • This supports the importance of early recognition of non-responders and rapid therapy adjustment to improve bleed management2

Patients respond differently, so it's important to have both agents. To help improve outcomes, FEIBA is an integral part of inhibitor management.

Efficacy: FEIBA versus rFVIIa

The FENOC study (FEIBA NovoSeven Comparative Study) was a prospective, open-label, randomized, multicenter, crossover study to determine the equivalence of 1 dose of FEIBA with 2 doses of rFVIIa.1

  • The primary end points were hemostatic effect and bleed resolution at 6 hours1
  • At 6 hours after treatment, patient assessment of both agents at both end points was similar —
    80.9% vs 78.7% for hemostatic effect (P=0.059)*; 76.1% vs 65.2% for bleed resolution (P=0.309)*1
  • On-demand efficacy with FEIBA is consistent with earlier trial results showing up to 93% efficacy in bleeding episodes1,5
  • FEIBA demonstrated comparable bleed resolution to rFVIIa at all time points, but the test for equivalence was not met1
    -Equivalence was defined as 15% difference in efficacy
  • 53.2% of bleeds were stopped within 2 hours with 1 FEIBA infusion1

Improving bleed management may require early therapy adjustment2,6

  • After initiating treatment with one bypassing agent, evaluate patient response frequently2
  • "Identification of non-responsiveness is based on various criteria: pain, swelling/tension, mobility, patient perception and laboratory parameters"6
  • International consensus guidelines emphasise the importance of early therapy adjustment at the first sign of unsatisfactory haemostatic response2
  • These guidelines suggest that optimising the timing of treatment decisions with early therapy adjustments may lead to faster responses and improved outcomes2
  • The risk of a potential interaction between rFVIIa and coagulation factor concentrates is unknown. Simultaneous use of prothrombin complex concentrates, activated or not, should be avoided. Consult the Prescribing Information for FEIBA and rFVIIa for the approved dosing

"Because the products [FEIBA and rFVIIa] promote thrombin generation by different mechanisms, there is reason to believe that the agents' actions may differ in individual cases."1

Making FEIBA an integral part of inhibitor management strategy may help improve patient outcomes.6

References

  1. 1. Astermark J, Donfield SM, DiMichele DM, et al; for the FENOC Study Group. A randomized comparison of bypassing agents in hemophilia complicated by an inhibitor: the FEIBA NovoSeven Comparative (FENOC) Study. Blood. 2007;109:546-551.
  2. 2. Teitel J, Berntorp E, Collins P, et al. A systematic approach to controlling problem bleeds in patients with severe congenital haemophilia A and high-titre inhibitors. Haemophilia. 2007;13:256-263.
  3. 3. US National Hemophilia Foundation. MASAC Recommendation 167 Regarding the Use of Bypassing Agents in Patients with Hemophilia A or B and Inhibitors. Available at: http://www.hemophilia.org/NHFWeb/MainPgs/MainNHF.aspx?menuid=57&contentid=579. Accessed July 2011.
  4. 4. Berntorp E. Differential response to bypassing agents complicates treatment in patients with haemophilia and inhibitors. Haemophilia. 2009;15:3-10.
  5. 5. Hilgartner MW, Knatterud GL, and the FEIBA Study Group. The use of factor eight inhibitor by-passing activity (FEIBA Immuno) product for treatment of bleeding episodes in hemophiliacs with inhibitors. Blood. 1983;61:36-40.
  6. 6. Berntorp E, Collins P, D'Oiron R, et al. Identifying non-responsive bleeding episodes in patients with haemophilia and inhibitors: a consensus definition. Haemophilia. 2010;1-9.

Rapid onset and sustained activity

FEIBA stops bleeds quickly and offers a long dosing interval. Read more

Treatment guidelines

Learn about a treatment algorithm developed to aid in the management of difficult-to-treat bleeds in patients with inhibitors. Read more

When bleeds don't resolve

Learn how to identify and respond to unresolved bleeds. Read more