Feiba

Factor VIII inhibitor bypassing activity

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 Individualized dosing. Recommended dose: 50-100 u/kg. Max single dose: 100 u/kg. Max daily dose: 200 u/kg. Max infusion rate: 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. Max: 200 u/kg daily. Other severe hemorrhages 100 u/kg at 12-hr intervals, may be administered at 6-hr intervals in individual cases. Max: 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- to 12-hr intervals. Max: 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 bd, may be administered concomitantly w/ factor VIII.

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

Discontinue administration at 1st sign or symptom of an infusion/hypersensitivity reaction. Risk of thrombotic & thromboembolic events, especially w/ high doses. 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, acute coronary ischemia, & signs & symptoms of other thrombotic or thromboembolic events. 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 counting if treatment response is inadequate. 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 Feiba 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). Possible transmission of infectious agents. Patients on controlled Na diet. Balance potential risks & only prescribe to pregnant or lactating women if clearly needed. Limited clinical trial data in elderly. Limited clinical data for bleeding prophylaxis in hemophilia B patients.

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

Possibility of thromboembolic events w/ systemic antifibrinolytics eg, tranexamic acid & aminocaproic acid; concomitant rFVIIa use. Risk of 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.

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