ReFacto®

Manufacturer: Wyeth Pharmaceuticals
Generic Name: Antihemophilic Factor VIII (Recombinant)

Indications: ReFacto® Antihemophlic Factor (Recombinant) is indicated for the control and prevention of hemorrhagic episodes and for surgical prophylaxis in patients with hemophilia A (congential factor VIII deficiency or classic hemophilia)

ReFacto® is indicated for short-term routine prophylaxis to reduce the frequency of spontaneous bleeding episodes. The effect of regular routine prophylaxis on long term morbidity and mortality is unknown.

ReFacto® can be of significant therapeutic value for treatment of hemophilia A in certain patients with inhibitors to factor VIII. In clinical studies of ReFacto, study subjects who developed inhibitors on study continued to manifest a clinicqal response when inhibitor titers were < 10BU. When an inhibitor is present, the dosage requirement of factor VIII is variable. The dosage can be determined only by a clinical response and by monitoring of circulating factor VIII levels after treatment.

Refacto® does not contain von Willebrand factor and is therefore not indicated in von Willebran's Disease.

ReFacto® Product Insert

How Supplied: Factor products are supplied in vials sizes of varying International Units (iu). Vial sizes (iu sizes) may change with each new lot of product manufactured. Vial sizes may range from approximately 200 - 1500 iu per vial.

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