NovoSeven

Recombinant coagulation factor VIIa, eptacog α (activated)

Bleeding episodes & prevention of bleeding in those undergoing surgery or invasive procedures in patients w/ congenital haemophilia w/ inhibitors to coagulation factors VIII or IX >5 Bethesda units & high anamnestic response to factor VIII or factor IX administration; w/ acquired haemophilia, congenital FVII deficiency & Glanzmann's thrombasthenia w/ Ab to GP IIb-IIIa &/or HLA, past or present platelet transfusions refraction. Severe postpartum haemorrhage when uterotonics are insufficient to achieve haemostasis.

Haemophilia A or B w/ inhibitors or expected to have high anamnestic response Initially 90 mcg/kg IV bolus inj at 2-3 hr intervals to obtain haemostasis, may be increased to every 4, 6, 8 or 12 hr once haemostasis is achieved. Mild to moderate bleeding episodes (including home therapy) 2-3 inj of 90 mcg/kg at 3-hr intervals, additional 90 mcg/kg dose may be given if required or 270 mcg/kg single inj. Home therapy duration: Not to exceed 24 hr. Serious bleeding episodes Initially 90 mcg/kg every 2nd hr until clinical improvement, may continue at 3-hr intervals for 1-2 days then may be increased to every 4, 6, 8 or 12 hr. Major bleeding episode Treat for 2-3 wk. Invasive procedure/surgery Initially 90 mcg/kg before intervention then repeated after 2 hr & then at 2-3 hr intervals for 1st 24-48 hr. Continue dose at 2-4 hr intervals for 6-7 days in major surgery, may then be increased to 6-8 hr for another 2 wk. Patient undergoing major surgery Treat for up to 2-3 wk. Acquired haemophilia Initially 90 mcg/kg IV bolus inj at 2-3 hr intervals, may be increased to every 4, 6, 8 or 12 hr once haemostasis is achieved. Factor VII deficiency 15-30 mcg/kg every 4-6 hr until haemostasis is achieved. Glanzmann's thrombasthenia 80-120 mcg/kg at 2-hr intervals for at least 3 doses to achieve haemostasis. Severe postpartum haemorrhage 60-90 mcg/kg IV bolus inj. 2nd dose may be administered after 30 min in case of insufficient haemostatic response.

Hypersensitivity to eptacog α or mouse, hamster or bovine protein.

Discontinue use if allergic or anaphylactic-type reactions occur. Advanced atherosclerotic disease, crush injury, septicaemia, disseminated intravascular coagulation; CHD, post-op patients, those at risk of thromboembolic events; clinical conditions eg, delivery, severe haemorrhage, transfusion, surgery/invasive procedures & coagulopathy; venous thromboembolic risk. Monitor prothrombin time & factor VII coagulant activity prior to & after therapy. Hepatic disease. Peripartum women. Avoid use during pregnancy. Lactation. Neonates.

Decreased therapeutic response, pyrexia; rash, pruritus, urticaria; venous thromboembolic events.

Reduced blood loss w/ anti-fibrinolytics. Avoid simultaneous use w/ prothrombin complex conc. Not recommended w/ rFXIII.

Haemostatics

B02BD08 - coagulation factor VIIa ; Belongs to the class of blood coagulation factors. Used in the treatment of hemorrhage.

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