Coagulation Factor VIIa [Eptacog Alfa]

• Hemophilia A and B with inhibitors: Treatment and control of bleeding episodes in patients with congenital hemophilia A or B who have developed inhibitors (neutralizing antibodies) against Factor VIII or IX.
• Perioperative management: Prevention and control of bleeding during surgery or invasive procedures in hemophilia patients with inhibitors.
• Acquired hemophilia: Treatment of bleeding episodes in patients with acquired Factor VIII inhibitors.
• Other rare bleeding disorders: Used off-label for severe bleeding in patients with Factor VII deficiency or other rare coagulation factor deficiencies when conventional treatments are inadequate or contraindicated.

• Dosing varies based on indication and severity of bleeding:
• Bleeding episodes: Initial dose of 90 mcg/kg intravenously; repeat every 2–3 hours until hemostasis is achieved.
• Surgical prophylaxis: 90 mcg/kg IV every 2 hours for first 24 hours; then every 4–6 hours as needed.
• Administration: Intravenous bolus injection over 2–5 minutes.
• Pediatrics: Similar dosing; individualized based on clinical response and weight.
• Elderly and special populations: No specific dose adjustments; careful monitoring advised.
• Dose adjustment: Based on clinical response; laboratory monitoring may guide dosing in some cases.

Eptacog alfa is a recombinant activated human coagulation Factor VII. It acts by binding to tissue factor exposed at the site of vascular injury, forming a complex that activates Factor X to Xa, which then converts prothrombin to thrombin. Thrombin generation leads to fibrin clot formation and cessation of bleeding. In patients with inhibitors to Factors VIII or IX, Eptacog alfa bypasses the need for these factors by directly activating the coagulation cascade downstream, promoting hemostasis.

• Absorption: Administered intravenously; immediate bioavailability.
• Distribution: Volume of distribution approximates plasma volume; rapid distribution.
• Metabolism: Cleared by proteolytic degradation in the liver and reticuloendothelial system.
• Elimination: Half-life approximately 2.3 hours (varies by individual).
• Onset of action: Rapid; hemostatic effect begins shortly after administration.
• Clearance: Primarily hepatic; not significantly affected by renal function.

• Pregnancy: No adequate controlled studies in pregnant women. Use only if clearly needed and potential benefit justifies potential risk.
• Lactation: Unknown if excreted in human milk; caution advised.

• Primary Class: Hemostatic Agent
• Subclass: Recombinant Coagulation Factor VIIa (Bypassing Agent)

• Known hypersensitivity to Eptacog alfa or any component of the formulation.
• Active thromboembolic events or high risk of thrombosis unless benefits outweigh risks.

• Monitor for thrombotic events (deep vein thrombosis, pulmonary embolism, arterial thrombosis), especially in patients with risk factors.
• Use with caution in patients with cardiovascular disease or history of thrombosis.
• Hypersensitivity reactions, including anaphylaxis, may occur; be prepared to manage accordingly.
• Not indicated for treatment of bleeding unrelated to hemophilia or inhibitor presence unless advised by specialist.
• Frequent clinical assessment of bleeding and coagulation status recommended during treatment.

Common:

• Injection site reactions (pain, erythema).
• Headache, fever, chills.

Serious (Rare):

• Thromboembolic events (e.g., myocardial infarction, stroke).
• Hypersensitivity reactions, including anaphylaxis.
• Development of neutralizing antibodies to recombinant Factor VIIa (rare).

• Concomitant use with other procoagulant or anticoagulant agents may alter risk of bleeding or thrombosis; monitor carefully.
• No significant CYP450 interactions.

• Current guidelines emphasize Eptacog alfa as first-line bypassing agent in hemophilia patients with inhibitors.
• Extended half-life recombinant factors are emerging alternatives, but Eptacog alfa remains widely used due to rapid onset and well-established efficacy.
• Monitoring protocols updated to emphasize vigilance for thrombotic complications.

• Store lyophilized powder and diluent at 2°C to 8°C (36°F to 46°F).
• Protect from light and freezing.
• Reconstitute immediately before use with supplied sterile diluent.
• Use reconstituted solution promptly; if necessary, may be stored refrigerated and used within recommended time (usually within 3 hours).
• Keep out of reach of children.