Novoseven (eptaccog Alfa)
Novoseven (eptaccog Alfa) Uses, Dosage, Side Effects, Food Interaction and all others data.
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).
| Trade Name | Novoseven (eptaccog Alfa) |
| Generic | Coagulation Factor VIIa (Eptacog Alfa) |
| Type | Injection |
| Therapeutic Class | Anti-fibrinolytic drugs |
| Manufacturer | Novo Nordisk India Pvt Ltd |
| Available Country | India |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Coagulation Factor VIIa is used for 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
Novoseven (eptaccog Alfa) dosage
Intravenous: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.
Add the recommended diluent (histidine), swirl gently until dissolved.
Side Effects
Nausea, vomiting, skin reactions, fever, headache and changes in BP. Rarely, anaphylaxis.
Precaution
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.
Interaction
Increased risk of thromboembolism with activated or non-activated prothrombin complex concentrate.
Pregnancy & Breastfeeding use
Pregnancy Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
Contraindication
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.
Storage Condition
Store between 2-25° C prior to reconstitution. Do not freeze. Protect from light.
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