Manufacturer
NOVO NORDISK A/S
Contents
Recombinant coagulation factor VIIa, eptacog α (activated)
Indication
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 & anamnestic response to factor VIII or factor IX administration, w/ acquired haemophilia, congenital FVII deficiency & Glanzmann's thrombasthenia w/ antibodies to GP IIb-IIIa &/or HLA & past or present platelet transfusions refraction.
Instruction
Haemophilia A or B w/ inhibitors or expected to have a high anamnestic response Initially 90 mcg/kg IV bolus inj at 2-3 hr intervals to obtain haemostasis, may be increased 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, another 90 mcg/kg dose may be added if required or 270-mcg/kg single inj. Home therapy: 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 increased dose 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 before intervention then repeated after 2 hr & then at 2-3 hr intervals for 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. 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 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.
Drug interaction
Avoid simultaneous use w/ prothrombin complex concentrates. Not recommended w/ rFXIII.
Malaysia
