Feiba

Treatment of bleeding in hemophilia A patients w/ inhibitors; hemophilia B patients w/ inhibitors, if no other specific treatment is available; non-hemophiliacs w/ acquired inhibitors to factor VIII. Prophylaxis of bleeding in hemophilia A patients w/ inhibitors who have experienced a significant bleed or are at high risk of significant bleeding.

IV (slow infusion) Recommended dose: 50-100 u/kg; must not exceed single dose of 100 u/kg & max daily dose of 200 u/kg unless severity of bleeding warrants & justifies use of higher doses. Infusion rate must not exceed 2 u/kg/min. Joint, muscle & soft tissue hemorrhage: Minor to moderately severe bleeding 50-75 u/kg at 12-hr intervals, severe muscle & soft tissue bleeding (eg, retroperitoneal hemorrhages) 100 u/kg at 12-hr intervals. Mucous membrane hemorrhage 50 u/kg every 6 hr, may be increased to 100 u/kg if bleeding does not stop. Max: Not to exceed 200 u/kg daily. Other severe hemorrhages (eg, CNS bleeding) 100 u/kg at 12-hr intervals, may be administered at 6-hr intervals in individual cases. Max: Not to exceed 200 u/kg daily. Surgery Initially 100 u/kg pre-op, then 50-100 u/kg after 6-12 hr. Post-op maintenance dose: 50-100 u/kg at 6-12 hr intervals. Max: Not to exceed 200 u/kg daily. Prophylaxis of bleeding in patient w/ high inhibitor titer & frequent hemorrhages after failed immune tolerance induction (ITI) or when ITI is not considered 70-100 u/kg every other day, may be increased to 100 u/kg daily or may be decreased gradually if necessary. Prophylaxis of bleeding in patient w/ high inhibitor titer during ITI 50-100 u/kg bid, may be administered concomitantly w/ factor VIII until factor VIII inhibitor titer has decreased to <2 Bethesda u.

Hypersensitivity. Disseminated intravascular coagulation (DIC). Acute thrombosis or embolism (including MI).

Discontinue administration at 1st sign or symptom of an infusion/hypersensitivity reaction, & thrombotic & thromboembolic events. Immediately discontinue if clinically significant changes in BP or pulse rate, resp distress, coughing or chest pain occur. Risk of thrombotic & thromboembolic events, especially w/ high doses. Use w/ caution & only if there are no therapeutic alternatives in patients w/ increased risk of thromboembolic complications including patients w/ history of CHD, liver disease, DIC, arterial or venous thrombosis, post-op immobilization, elderly & neonates. Safety & efficacy for breakthrough bleeding in patients receiving emicizumab has not been established. Carefully monitor patients receiving ≥100 u/kg, particularly for the development of DIC &/or acute coronary ischemia & for symptoms of other thrombotic or thromboembolic events. Patients w/ inhibitor hemophilia or acquired inhibitors to coagulation factors may have increased bleeding tendency & increased risk of thrombosis at the same time. In vitro tests eg, aPTT, whole blood coagulation time & thromboelastograms as proof of efficacy do not have to correlate w/ the clinical picture. Conduct thrombocyte count if treatment response is inadequate. Consider use of another agent in case of insufficient response to 1 bypassing agent. May result in initial anamnestic rise in inhibitor levels. Transitory rise of passively transferred hepatitis B surface Abs may result in misleading interpretation of +ve results in serological testing after administration of high doses. Passive transmission of Abs to erythrocyte antigens (eg, A, B, D) may interfere w/ some serological tests for red cell Abs eg, antiglobulin test (Coombs test). Limited clinical data for bleeding prophylaxis in hemophilia B patients. Possible transmission of infectious agents; consider appropriate vaccination (hepatitis A & B) for patients in regular/repeated receipt of human plasma-derived products including Feiba. Patients on controlled Na diet. Not to be used antifibrinolytics for approx 6-12 hr after administration of Feiba. Balance potential risks & only prescribe to pregnant or lactating women if clearly needed. Limited clinical trial data in elderly & childn <6 yr.

Hypersensitivity; headache, dizziness; hypotension; rash; +ve hepatitis B surface Ab.

Possibility of thromboembolic events w/ systemic antifibrinolytics eg, tranexamic acid & aminocaproic acid; concomitant recombinant FVIIa use. May result in thromboembolic events & thrombotic microangiopathy w/ emicizumab.

Haemostatics

B02BD03 - factor VIII inhibitor bypassing activity ; Belongs to the class of blood coagulation factors. Used in the treatment of hemorrhage.

Rx