Factor viia, recombinant

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.
Reconstitution: Add the recommended diluent (histidine), swirl gently until dissolved.
Incompatibility: Should not be mixed w/ infusion soln or be given in a drip.

Intravenous
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.
Reconstitution: Add the recommended diluent (histidine), swirl gently until dissolved.
Incompatibility: Should not be mixed w/ infusion soln or be given in a drip.

Intravenous
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.
Reconstitution: Add the recommended diluent (histidine), swirl gently until dissolved.
Incompatibility: Should not be mixed w/ infusion soln or be given in a drip.

Hypersensitivity to hamster, bovine or mouse proteins.

Patient w/ conditions associated w/ circulating tissue factor (e.g. advanced atherosclerosis, crush injury or septicaemia) due to risk of precipitating thrombosis or disseminated intravascular coagulation. Pregnancy and lactation. Monitoring Parameters Monitor prothrombin time/INR, aPTT and factor VII clotting activity prior to and after therapy.

Nausea, vomiting, skin reactions, fever, headache and changes in BP. Rarely, anaphylaxis.

Increased risk of thromboembolism w/ activated or non-activated prothrombin complex concentrate.

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 w/ tissue factor and may activate coagulation factor X and factor IX. Factor VIIa is given as the recombinant form, eptacog alfa (activated).
Distribution: Volume of distribution: 103 mL/kg.
Excretion: Elimination half-life: 2.3 hr.

Intravenous: Store between 2-25°C prior to reconstitution. Do not freeze. Protect from light.

Haemostatics