factor viia, recombinant


Novo Nordisk


Concise Prescribing Info
Eptacog α (activated)
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; congenital haemophilia who are expected to have high anamnestic response to factor VIII or IX administration; acquired haemophilia; congenital FVII deficiency; Glanzmann's thrombasthenia w/ past or present refractoriness to platelet transfusions or where platelets are readily unavailable.
Dosage/Direction for Use
Haemophilia A or B w/ inhibitor 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 successively to every 4, 6, 8 or 12 hr if continued therapy is needed. Mild to moderate bleeding episode (including home therapy) 2-3 inj of 90 mcg/kg at 3-hr intervals, an additional dose of 90 mcg/kg may be administered if required; or as a single inj of 270 mcg/kg. Home therapy: Not to exceed 24 hr. Serious bleeding episode Initially 90 mcg/kg every 2 hr, can be increased at 3-hr intervals for 1-2 days, then may be increased successively 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 prior to intervention, repeated after 2 hr & then at 2-3 hr intervals for the 1st 24-48 hr. In major surgery, continue dose at 2-4 hr intervals for 6-7 days, may then be increased to 6-8 hr for another 2 wk. Patient undergoing major surgery may be treated for up to 2-3 wk. Acquired haemophilia Initially 90 mcg/kg IV bolus inj at 2-3 hr intervals, may be increased successively 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 At least 3 doses of 90 mcg/kg (range: 80-120 mcg/kg) bolus inj at 2-hr intervals (1.5-2.5 hr).
Hypersensitivity to eptacog α or mouse, hamster or bovine protein.
Special Precautions
Discontinue use 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 disseminated intravascular coagulation. Patients w/ history of CHD, post-op patients, patients at risk of thromboembolic phenomena. Monitor prothrombin time & factor VII coagulant activity prior to & after treatment in factor VII deficient patients. Liver disease. Avoid use during pregnancy. Lactation. Neonates.
Adverse Reactions
Decreased therapeutic response, pyrexia; rash, pruritus, urticaria; venous thromboembolic events.
Drug Interactions
Avoid simultaneous use w/ prothrombin complex concentrates. Not recommended to combine rFVIIa & rFXIII. Reports of reduced blood loss w/ anti-fibrinolytics.
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 1 mg
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