Coagulation Factor VIIa is indicated for the treatment of bleeding episodes in patients with hemophilia. It is also used to manage bleeding associated with surgery or invasive procedures in patients with factor VII deficiency, and in patients with Glanzmann’s thrombasthenia undergoing surgical or invasive procedures.

Recombinant Factor VIIa is a biosynthetic (man-made) form of activated factor VII, produced using recombinant DNA technology. It is a vitamin K-dependent glycoprotein. It promotes hemostasis (stops bleeding) by activating the extrinsic pathway of the blood coagulation cascade. When administered, it replaces deficient or missing activated factor VII. Factor VIIa forms a complex with tissue factor (a protein exposed at injury sites), and this complex then activates factor X and factor IX, leading to thrombin generation and clot formation. Factor VIIa is available as the recombinant form called eptacog alfa (activated).

Bleeding episodes in patients with haemophilia:

• Adult: As activated eptacog alfa: Initial dose 90 mcg/kg given by IV bolus over 2–5 minutes. Additional doses may be administered as needed to achieve or maintain haemostasis, usually every 2–3 hours initially. Dose or dosing interval may be adjusted based on patient response. In severe bleeding, treatment may continue for up to 3 weeks or longer.

Bleeding episodes due to surgery or invasive procedures in patients with factor VII deficiency:

• Adult: As activated eptacog alfa: 15–30 mcg/kg every 4–6 hours via IV bolus over 2–5 minutes until haemostasis is achieved.

Bleeding episodes due to surgery or invasive procedures in Glanzmann's thrombasthenia:

• Adult: As activated eptacog alfa: 90 mcg/kg every 2 hours via IV bolus over 2–5 minutes, with at least 3 doses administered.

The risk of thromboembolism (blood clots) may be increased when Coagulation Factor VIIa is used together with activated or non-activated prothrombin complex concentrates.

Hypersensitivity to recombinant coagulation factor VIIa or to proteins of mouse, hamster, or bovine origin. It is also contraindicated in patients with rare hereditary disorders such as fructose intolerance, glucose malabsorption, or sucrose-isomaltase deficiency.

Nausea, vomiting, skin reactions, fever, headache, and changes in blood pressure may occur. Rarely, anaphylaxis has been reported.

Use during pregnancy is generally not recommended. Animal studies have shown adverse effects on the fetus (teratogenic or embryocidal), and there are no adequate and well-controlled studies in pregnant women. The drug should be used only if the expected benefit outweighs the potential risk to the fetus.

It is not known whether eptacog alfa is excreted in human breast milk. Its excretion in milk has not been studied in animals.

Use with caution in patients with advanced atherosclerosis, crush injuries, septicemia, or disseminated intravascular coagulation (DIC). Caution is also required in patients with a history of coronary heart disease, liver disease, those undergoing major surgery, or those at risk of thromboembolic events or DIC.There is a remote possibility of hypersensitivity to mouse IgG, bovine IgG, and other residual culture proteins. Prothrombin time and factor VII coagulant activity should be monitored in patients with factor VII deficiency. Use with caution in pregnancy, lactation, and in neonates.

Anti-fibrinolytic drugs

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