• Bleeding disorders

Refacto Generic Name & Formulations

General Description

Antihemophilic Factor VIII (recombinant) 250 IU, 500 IU, 1000 IU, 2000 IU; per vial; lyophilized pwd for IV infusion after reconstitution; preservative-free.

Pharmacological Class

Clotting factor.

How Supplied

Single-use vial—1 (w. diluent, supplies)


Refacto Indications


Prevention and control of hemorrhagic episodes and for surgical prophylaxis in Hemophilia A. Short-term routine prophylaxis to reduce frequency of spontaneous bleeding episodes.

Refacto Dosage and Administration

Adults and Children

Dosage Required (IU) = Body Weight (kg) × Desired % Factor VIII Increase × 0.5. Individualize. Infuse at rate comfortable to patient. Minor hemorrhage: obtain 20–40% FVIII increase; give every 12–24hrs for at least 1 day until resolved. Moderate hemorrhage and tooth extraction: obtain 30–60% FVIII increase; give every 12–24hrs for 3–4 days until adequate hemostasis; for tooth extraction: a single infusion plus oral antifibrinolytic therapy within 1hr may be sufficient. Major hemorrhage: obtain 60–100% FVIII increase; give every 8–24hrs until resolved; or, for surgery, until local hemostasis achieved. Prophylaxis: give ≥2 times weekly; children may need shorter dosage intervals or higher doses.

Refacto Contraindications


Mouse or hamster protein sensitivity.

Refacto Boxed Warnings

Not Applicable

Refacto Warnings/Precautions


Not for von Willebrand's disease. Confirm Factor VIII deficiency prior to treatment. Monitor for development of Factor VIII inhibitors. Pregnancy (Cat.C). Nursing mothers.

Refacto Pharmacokinetics

See Literature

Refacto Interactions

Not Applicable

Refacto Adverse Reactions

Adverse Reactions

Allergic reactions, headache, fever, chills, flushing, nausea, vomiting, lethargy, pruritus, antibody formation.

Refacto Clinical Trials

See Literature

Refacto Note

Not Applicable

Refacto Patient Counseling

See Literature