NovoSeven
Daily Dose:
Course Duration:
Cheaper & Alternative Brands (1 mg/vial)
Same active generic (Coagulation Factor VIIa [Eptacog Alfa]), same form (IV Injection), exact same strength (1 mg/vial)No other brands currently registered with this exact active generic and dosage form.
Clinical Prescribing Information
Medical monograph and safety information for healthcare professionals & patients.Indications & Clinical Uses
NovoSeven is indicated in Bleeding episodes in patients with haemophilia, Bleeding episodes due to surgery or invasive procedures in patients with factor VII deficiency, Bleeding episodes due to surgery or invasive procedures in Glanzmann's thrombasthenia.
Dosage & Administration
Bleeding episodes in patients with haemophilia:
Adult
: As activated eptacog alfa: Initially, 90 mcg/kg given via IV bolus over 2-5 min. Additional dose may be given as needed to achieve or maintain haemostasis, initially 2-3 hrly. May adjust dose or dosing interval according to response. May continue therapy for up to 3 wk or more in cases of serious bleeding episodes.
Bleeding episodes due to surgery or invasive procedures in patients with factor VII deficiency:
Adult
: As activated eptacog alfa: 15-30 mcg/kg 4-6 hrly via IV bolus over 2-5 min until haemostasis is achieved.
Bleeding episodes due to surgery or invasive procedures in Glanzmann's thrombasthenia:
Adult
: As activated eptacog alfa: 90 mcg/kg 2 hrly via IV bolus over 2-5 min, give at least 3 doses.
Contraindications
Hypersensitivity to recombinant coagulation factor VIIa or to mouse, hamster or bovine protein. Rare hereditary problems of fructose intolerance, glucose malabsorption or sucrose-isomaltase insufficiency.
Side Effects & Adverse Reactions
Nausea, vomiting, skin reactions, fever, headache and changes in BP. Rarely, anaphylaxis.
Warnings & Precautions
Advanced atherosclerotic disease, crush injury, septicemia or disseminated intravascular coagulation. Patients w/ history of CHD, liver disease, undergoing major surgery, at risk of thromboembolic phenomena or disseminated intravascular coagulation. Remote possibility of hypersensitivity to mouse IgG, bovine IgG & other residual culture proteins. Monitor prothrombin time & factor VII coagulant activity in factor VII deficient patients. Pregnancy & lactation. Neonates.
Pharmacology & Mechanism of Action
Recombinant factor VIIa is a biosynthetic preparation of activated factor VII produced by recombinant DNA technology. It is a vitamin K-dependent glycoprotein. It promotes haemostasis by activating the extrinsic pathway of the coagulation cascade. It replaces deficient activated coagulation factor VII, which complexes with tissue factor and may activate coagulation factor X and factor IX. Factor VIIa is given as the recombinant form, eptacog alfa (activated).