NovoSeven

NovoSeven

eptacog alfa (activated)

Manufacturer:

Novo Nordisk

Distributor:

Firma Chun Cheong
/
DKSH
Concise Prescribing Info
Contents
Eptacog α (activated, recombinant coagulation factor VIIa)
Indications/Uses
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/ past or present refractoriness to platelet transfusions or where platelets are not readily available. Severe postpartum haemorrhage when uterotonics are insufficient to achieve haemostasis.
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 dose interval 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). Severe postpartum haemorrhage 60-90 mcg/kg, a 2nd dose can be administered after 30 min in case of insufficient haemostatic response.
Contraindications
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. Caution in patients w/ history of CHD, liver disease, post-op patients, pregnant or peripartum women, neonates, or patients at risk of thromboembolic events 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. Preferable to avoid use during pregnancy. Risk of thromboembolic complications in severe postpartum haemorrhage & pregnancy. Discontinue breastfeeding or the therapy taking into account the benefit of breastfeeding to the child & the benefit of therapy to the woman.
Adverse Reactions
Uncommon: Decreased therapeutic response, pyrexia; rash, pruritus & urticaria; venous thromboembolic events.
Drug Interactions
Avoid simultaneous use of prothrombin complex conc. Combination of rFVIIa & rFXIII is not recommended.
MIMS Class
Haemostatics
ATC Classification
B02BD08 - coagulation factor VIIa ; Belongs to the class of blood coagulation factors. Used in the treatment of hemorrhage.
Presentation/Packing
Form
NovoSeven powd for inj 50 KIU
Packing/Price
1's
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