NovoSeven

NovoSeven

factor viia, recombinant

Manufacturer:

Novo Nordisk

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Eptacog α (activated)
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 factor VIII or IX >5 BU; w/ congenital haemophilia who are expected to have a high anamnestic response to factor VIII or IX administration; w/ acquired haemophilia.
Dosage/Direction for Use
Initially 90 mcg/kg body wt IV bolus. Further inj may be repeated. Dose interval initially 2-3 hr to obtain haemostasis. Duration of treatment & interval between inj will vary w/ the severity of haemorrhage, invasive procedures or surgery performed.
Contraindications
Hypersensitivity to eptacog α, the excipients, or to mouse, hamster or bovine proteins.
Special Precautions
Patients w/ history of CHD, liver disease, undergoing & following major surgery, at risk of thromboembolic phenomena or disseminated intravascular coagulation. Discontinue use if allergic or anaphylactic-type reactions occur. Rare hereditary problems of fructose intolerance, glucose malabsorption or sucrose-isomaltase insufficiency. Pregnancy & lactation. Neonates.
Adverse Reactions
Rash (allergic dermatitis & rash erythematous), pruritus, urticaria; decreased therapeutic response, pyrexia; venous thromboembolic events (DVT, thrombosis at IV site, pulmonary embolism, thromboembolic events of liver including portal vein thrombosis, renal vein thrombosis, thrombophlebitis, superficial thrombophlebitis & intestinal ischaemia). Antibody formation.
Drug Interactions
Risk of potential drug interaction w/ coagulation factor conc unknown. Avoid simultaneous use of prothrombin complex conc, activated or not. Experience w/ concomitant administration of antifibrinolytics & NovoSeven treatment is limited. Not recommended to combine rFVIIa & rFXIII.
MIMS Class
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 1 mg
Packing/Price
(+ 1 mL solvent pre-filled syringe) 1's
Form
NovoSeven powd for inj 2 mg
Packing/Price
(+ 2 mL solvent pre-filled syringe) 1's
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