Coagulation Factor VIIa [Eptacog Alfa]

Coagulation Factor VIIa [Eptacog Alfa] belongs to the anti-fibrinolytic drugs group. Doctors prescribe it mainly for Coagulation Factor VIIa 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. Dose, duration and suitability differ from patient to patient, so it should be taken only under a registered physician's advice.

Coagulation Factor VIIa [Eptacog Alfa] is used in the conditions listed below: • Coagulation Factor VIIa 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

Anti-fibrinolytic drugs

How Coagulation Factor VIIa [Eptacog Alfa] works — key points: • 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)..

Recommended schedule as per the manufacturer's literature: • 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.

Reactions reported with Coagulation Factor VIIa [Eptacog Alfa]: • Nausea, vomiting, skin reactions, fever, headache and changes in BP. Rarely, anaphylaxis

Points to keep in mind while on Coagulation Factor VIIa [Eptacog Alfa]: • 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..

Avoid Coagulation Factor VIIa [Eptacog Alfa] in the following situations: • 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

Watch for these combinations: • Increased risk of thromboembolism with activated or non-activated prothrombin complex concentrate

Use during pregnancy: It is preferable to avoid use during pregnancy. 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.

Use while breastfeeding: It is unknown whether eptacog alfa is excreted in human breast milk. The excretion of eptacog alfa in milk has not been studied in animals..

Kidney and liver considerations: Patients w/ history of CHD, liver disease, undergoing major surgery, at risk of thromboembolic phenomena or disseminated intravascular coagulation.

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