NovoSeven RT

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 u; w/ congenital haemophilia who are expected to have a high anamnestic response to factor VIII or IX administration; w/ acquired haemophilia; w/ congenital FVII deficiency; w/ Glanzmann's thrombasthenia w/ past or present refractoriness to platelet transfusions, or where platelets are not readily available. Treatment of severe postpartum haemorrhage when uterotonics are insufficient to achieve haemostasis.

Administer by IV bolus inj over 2-5 min. Hemophilia A or B w/ inhibitors or expected to have a high anamnestic response Initially 90 mcg/kg given as early as possible after start of bleeding episode. Further inj may be repeated at interval of initially 2-3 hr to obtain haemostasis. If continued therapy is needed, dose interval can be increased successively once effective haemostasis is achieved to every 4, 6, 8 or 12 hr for as long as treatment is judged as indicated. Mild to moderate bleeding episode (including home therapy) 2-3 inj of 90 mcg/kg given at 3-hr intervals (if further treatment is required, 1 additional dose of 90 mcg/kg can be given), or 1 single inj of 270 mcg/kg. Max duration of home therapy: 24 hr. Serious bleeding episode Initially 90 mcg/kg administered on the way to the hospital. Dose frequency should initially be every 2nd hr until clinical improvement is observed. If continued therapy is indicated, dose interval can be increased to 3 hr for 1-2 days. Thereafter, dose interval can be increased successively to every 4, 6, 8 or 12 hr for as long as treatment is judged as indicated. Major bleeding episode may be treated for 2-3 wk but can be extended if clinically warranted. Invasive procedure/surgery Initially 90 mcg/kg immediately prior to intervention, repeated after 2 hr & then at 2-3 hr intervals for the 1st 24-48 hr depending on the intervention performed & the patient's clinical status. In major surgery, dose should be continued at 2-4 hr intervals for 6-7 days, then dose interval may be increased to 6-8 hr for another 2 wk. Patient undergoing major surgery may be treated for up to 2-3 wk until healing has occurred. Acquired hemophilia Initially 90 mcg/kg given as early as possible after start of a bleeding episode. Further inj may be repeated at interval of initially 2-3 hr. Once haemostasis has been achieved, dose interval can be increased successively to every 4, 6, 8 or 12 hr for as long as treatment is judged as indicated. 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 (80-120 mcg)/kg at intervals of 2 hr (1.5-2.5 hr). Severe postpartum haemorrhage 60-90 mcg/kg. Administer 2nd dose after 30 min in case of insufficient haemostatic response.

Hypersensitivity to eptacog α (activated) or to mouse, hamster or bovine protein.

Immediately discontinue use if allergic or anaphylactic-type reactions occur. Potential risk of development of thrombotic events or induction of disseminated intravascular coagulation (DIC) in pathological conditions in which tissue factor may be expressed more extensively than considered normal. Caution in patients w/ history of coronary heart disease, w/ liver disease, post-op patients, pregnant or peripartum women, neonates, or to those at risk of thromboembolic events or DIC. Monitor factor VII-deficient patients for prothrombin time & factor VII coagulant activity before & after administration. Reports of thrombosis during surgery in FVII-deficient patients receiving treatment. Avoid use during pregnancy. Discontinue breast-feeding or the therapy taking into account the benefit of breast-feeding to the child & the benefit of therapy to the woman.

Uncommon: Decreased therapeutic response, pyrexia, rash, venous thromboembolic events, pruritus & urticaria.

Avoid simultaneous use of prothrombin complex conc (activated or not). Limited experience in concomitant administration w/ antifibrinolytics. Not recommended in combination w/ rFXIII.

Haemostatics

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

Rx