Last reviewed 2026-04-22 · How we verify

ReFacto

ReFacto is a recombinant antihemophilic factor (Factor VIII) that replaces deficient or dysfunctional clotting factor VIII to restore blood coagulation in hemophilia A patients.

ReFacto is a recombinant antihemophilic factor (Factor VIII) that replaces deficient or dysfunctional clotting factor VIII to restore blood coagulation in hemophilia A patients. Used for Hemophilia A (congenital Factor VIII deficiency) — prevention and treatment of bleeding episodes, Perioperative management in hemophilia A patients.

At a glance

Mechanism of action

ReFacto is a recombinant DNA-derived Factor VIII produced in Chinese hamster ovary (CHO) cells. It functions as a cofactor in the intrinsic pathway of blood coagulation, working with Factor IX to activate Factor X and initiate the cascade leading to thrombin generation and clot formation. By replacing the missing or defective Factor VIII in hemophilia A patients, it restores normal hemostatic function and prevents or controls bleeding episodes.

Approved indications

• Hemophilia A (congenital Factor VIII deficiency) — prevention and treatment of bleeding episodes
• Perioperative management in hemophilia A patients

Common side effects

• Inhibitor development (anti-Factor VIII antibodies)
• Injection site reactions
• Headache
• Fever
• Allergic reactions

Key clinical trials

• Long-term Study Evaluating Joint Health in People With Haemophilia A Receiving Real-world Prophylactic Treatment With Efanesoctocog Alfa (PHASE4)
• A 48-Month Study to Evaluate Long-Term Effectiveness of Elocta on Joint Health
• Phase 3 Study for Efficacy and Safety Outcomes Data in Japanese Patients With Severe Hemophilia A (PHASE3)
• Study to Test the Safety and How Well Patients With Severe Hemophilia A Respond to Treatment With BAY 2599023 (DTX 201), a Drug Therapy That Delivers a Healthy Version of the Defective Factor VIII Gene Into the Nucleus of Liver Cells Using an Altered, Non-infectious Virus (AAV) as a "Shuttle" (PHASE1, PHASE2)
• An Observational Study to Learn More About How Well Damoctocog Alfa Pegol Works in Previously Treated Children With Hemophilia A
• A Study to Assess the Efficacy and Safety of Emicizumab in Participants With Type 3 Von Willebrand Disease (PHASE3)
• An Observational Study of Participants With Type 3 Von Willebrand Disease on Prophylactic Standard-of-Care Treatment
• Evaluation of the Safety and Efficacy of Hemophilia A Gene Therapy Drugs (PHASE2, PHASE3)

Primary sources

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