factor viia, recombinant


Novo Nordisk


Firma Chun Cheong
Concise Prescribing Info
Eptacog α (activated, recombinant coagulation factor VIIa)
Treatment of 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 (BU); congenital haemophilia expected to have high anamnestic response to factor VIII or IX administration; acquired haemophilia; congenital FVII deficiency; Glanzmann's thrombasthenia w/ Ab to GP IIb-IIIa &/or HLA, & w/ past or present refractoriness to platelet transfusions.
Dosage/Direction for Use
IV bolus inj Haemophilia A or B w/ inhibitors or expected to have a high anamnestic response Initially 90 mcg/kg, 2-3 hr to obtain haemostasis, then may be increased to every 4, 6, 8 or 12 hr, if continued therapy is needed. Mild to moderate bleeding episodes (including home therapy) 2-3 inj of 90 mcg/kg every 3 hr; or single 270 mcg/kg. Max home therapy duration: 24 hr. Serious bleeding episodes Initially 90 mcg/kg every 2 hr, can be increased to every 3 hr for 1-2 days. Thereafter, can be increased to every 4, 6, 8 or 12 hr. Major bleeding episode may be treated for 2-3 wk. Invasive procedure/surgery Initially 90 mcg/kg, repeated after 2 hr, then at 2-3 hr intervals for the 1st 24-48 hr. Dose should be continued at 2-4 hr intervals for 6-7 days in major surgery; may be increased to 6-8 hr for another 2 wk. Patients undergoing major surgery may be treated for up to 2-3 wk. Acquired haemophilia Initially 90 mcg/kg every 2-3 hr, may be increased to every 4, 6, 8 or 12 hr once haemostasis has been achieved. Factor VII deficiency 15-30 mcg/kg every 4-6 hr. Glanzmann's thrombasthenia At least 3 doses of 90 mcg (80-120 mcg)/kg every 2 hr (1.5-2.5 hr).
Hypersensitivity to eptacog α, or to mouse, hamster or bovine protein.
Special Precautions
Discontinue if allergic or anaphylactic-type reactions occur. Risk of thrombotic events or induction of disseminated intravascular coagulation (DIC) in patients w/ advanced atherosclerotic disease, crush injury, septicaemia or DIC. Use cautiously in patients w/ history of CHD; liver disease; post-op patients; neonates; patients at risk of thromboembolic phenomena or DIC. Monitor prothrombin time & factor VII coagulant activity of factor VII deficient patients before & after administration. Risk of Ab formation. Reports of thrombosis in FVII deficient patients undergoing surgery. Pregnancy & lactation.
Adverse Reactions
Uncommon: Decreased therapeutic response, pyrexia; rash, pruritus & urticaria; venous thromboembolic events.
Drug Interactions
Avoid simultaneous use of prothrombin complex concentrates. Reports of reduced blood loss w/ anti-fibrinolytics. Combination of rFVIIa & rFXIII is not recommended.
MIMS Class
ATC Classification
B02BD08 - coagulation factor VIIa ; Belongs to the class of blood coagulation factors. Used in the treatment of hemorrhage.
NovoSeven powd for inj 50 KIU
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