Hemophilia Solutions

Issue Five · June 2003

Wyeth Pharmaceuticals is pleased to communicate the following:

New Assay Standard for ReFacto: What Does This Mean to Patients?

The consistent measurement of clotting factor activity units is important for treating bleeds successfully, especially in the surgery setting. Assays used to measure clotting factor activity are very complex and differ among laboratories.

Wyeth has adopted a new assay standard for ReFacto^® Antihemophilic Factor (Recombinant). This new standard should yield greater agreement among test results used to monitor treatment.

As a result of this change, the amount of ReFacto protein in each International Unit (IU) will increase by approximately 20 percent. The price per IU will remain the same. The Prescribing Information for ReFacto remains the same.

Individuals who currently use ReFacto should continue using their current supply of ReFacto. Patients transitioning to ReFacto calibrated with the new standard should initially use the same dose as previously prescribed. Once transitioned to ReFacto calibrated with the new standard, they should remain on this product. As with all factor VIII products, patients' dose should be individually titrated to desired clinical response.

Patients should consult with their health care provider regarding their specific treatment regimen.

New ReFacto Packaging Coming Soon

ReFacto calibrated with the new standard will be introduced with new and distinctive packaging. Each of the four vial sizes will have color-coded packaging:

• Yellow: 250 IU/kg
• Blue: 500 IU/kg
• Green: 1000 IU/kg
• Red: 2000 IU/kg

ReFacto calibrated with the new standard in the new color-coded packaging will be available pending approval by the U.S. Food and Drug Administration (FDA).

Important Product Information

ReFacto^® Antihemophilic Factor (Recombinant) is indicated for the control and prevention of hemorrhagic episodes and for surgical prophylaxis in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia) and 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.

As with the intravenous administration of any protein product, adverse reactions may include headache, fever, chills, flushing, nausea, vomiting, fatigue, or symptoms of allergic reactions. The remote possibility exists for hypersensitivity to non-human mammalian proteins.

Please see Product Information.

Commitment to the Hemophilia Community

We will continue to update you on our progress as we move forward with our plans. Today, as always, our goal is to create effective recombinant factor products with enhanced viral safety for the hemophilia community.

For past issues of Hemophilia Solutions, please contact us at 484-865-3256. If you wish to update your information in our database, please contact us at the same number.

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