Feiba

Human plasma protein w/ Factor VIII inhibitor bypassing activity

Treatment & prophylaxis of bleeding in haemophilia A w/ factor VIII inhibitor, & haemophilia B w/ factor IX inhibitor; non haemophiliacs w/ acquired inhibitors to factors VIII, XI, XII. Von Willebrand's disease. In combination w/ factor VIII conc for continual long term therapy to achieve complete & permanent elimination of factor VIII inhibitor to allow regular treatment in patients w/o inhibitor.

IV inj or infusion Max rate: 2 u/kg/min. Recommended dose: 50-100 u/kg. Max of 100 u/kg as single dose & 200 u/kg as daily dose. Spontaneous haemorrhage: Joint, muscle & soft tissue: Minor to moderate bleeding 50-75 u/kg at 12-hr interval. Continue until relief of pain, reduction of swelling or joint mobilization. Major muscle & soft tissue haemorrhage eg, retroperitoneal bleeding 100 u/kg at 12-hr interval. Mucous membrane haemorrhage 50 u/kg every 6 hr w/ careful monitoring of patient's visible bleeding site, repeated measurements of haematocrit. May be increased to 100 u/kg if bleeding persist. Max: 200 u/kg daily. Other severe haemorrhages eg, CNS bleeding 100 u/kg at 12-hr interval. May be given at 6-hr interval. Max: 200 u/kg daily. Surgery Initially 100 u/kg pre-op & further dose of 50-100 u/kg after 6-12 hr. Post-op maintenance dose: 50-100 u/kg at 6-12 hr interval. Max: 200 u/kg daily. Bleeding prophylaxis Haemophilia A patients w/ inhibitors during immune tolerance therapy (ITT) or if ITT falls 50-100 u/kg bid w/ concomitant factor VIII conc until reduction of factor VIII inhibitor to 1 B.U. (Bethesda Unit). Patient w/ high inhibitor titre & frequent haemorrhages 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.

Hypersensitivity. Disseminated intravascular coagulation (DIC); liver damage due to delayed clearance of activated coagulation factors. MI, acute thrombosis &/or embolism.

Discontinue treatment at 1st sign or symptom of infusion/hypersensitivity reaction; thromboembolic events; in case of significant changes in BP, pulse rate, resp distress, chest pain & cough. Hypersensitivity reactions including urticaria, angioedema, GI manifestations, bronchospasm & hypotension; anaphylaxis; other infusion reactions eg, chills, pyrexia & HTN. Thromboembolic events including DIC, venous thrombosis, pulmonary embolism, MI & stroke. Bleeding tendency & increased risk of thrombosis in non-haemophilic patients w/ acquired inhibitor against factors VIII, XI or XII. Risk of transmitting infectious agents eg, viruses. Initial anamnestic rise in inhibitor levels in patients w/ inhibitors. Doses >200 u/kg daily or in patients w/ risk factors including DIC, advanced atherosclerotic disease, crush injury or septicemia. Patients w/ congenital & acquired hemophilia; on low Na diet. Weigh benefit & risk of re-exposure. Perform standard measures to prevent infections resulting from use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations & plasma pools for specific markers of (limited value against non-enveloped viruses eg, parvovirus B19). Lab results indicative of DIC eg, decreased fibrinogen values & platelet count &/or presence of fibrin/fibrinogen degradation products; other indications include significantly prolonged thrombin time, prothrombin time, or partial thromboplastin time (PTT). May not correlate PTT, whole blood clotting time & thromboelastogramme w/ clinical improvement. May result in misleading interpretation of +ve results in serological testing due to high dose administration; interfere w/ antiglobulin test (Coombs test). Perform platelet count in case of inadequate response to treatment. Consider appropriate vaccination against hepatitis A & B in patients w/ regular/repeated receipt of plasma-derived products; use of another agent in case of insufficient response w/ one bypassing agent. Concomitant use w/ emicizumab for breakthrough bleeding; recombinant Factor VIIa may increase risk of developing thromboembolic event. Pregnancy & lactation.

Increased inhibitor titer (anamnestic response); hypersensitivity; somnolence, dizziness, dysgeusia, headache; hypotension; dyspnea; nausea; rash; chills, pyrexia, chest pain & discomfort; hepatitis B surface Ab +ve. Disseminated intravascular coagulation; anaphylactic reaction; paresthesia, thrombotic & embolic stroke; MI, tachycardia; thrombosis, venous & arterial thrombosis, HTN, flushing; pulmonary embolism, bronchospasm, wheezing, cough; vomiting, diarrhea, abdominal discomfort; angioedema, urticaria, pruritus; malaise, feeling hot, inj site pain.

Possible thromboembolic events w/ systemic antifibrinolytics eg, tranexamic acid & aminocaproic acid; recombinant factor VIIa. Concomitant use w/ emicizumab.

Haemostatics

B02BD02 - coagulation factor VIII ; Belongs to the class of blood coagulation factors. Used in the treatment of hemorrhage.

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