Bayer HealthCare is in the process of communicating with patients, through letters and e-mails to pharmacies and distributors, on the importance of the label information for filtering both Kogenate® FS and Kogenate® FS with BIO-SET. Questions received by the company’s Medical Information Department prompted the action. Bayer’s Kogenate® FS is a recombinant factor VIII (rFVIII) therapy indicated for the control and prevention of bleeding episodes and peri-operative management in adults and children (0-16 years) with hemophilia A. Kogenate® FS is also indicated for routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A with no pre-existing joint damage.
Bayer HealthCare is emphasizing the necessity of properly filtering factor products, by following reconstitution and/or administration steps described in the approved product labeling. For Kogenate® FS products, it is recommended that patients use the butterfly infusion set provided with the product because it incorporates an in-line filter. Parenteral drugs (those administered via intravenous or intramuscular injection) such as Kogenate® FS products should be inspected visually for particulate matter and discoloration prior to administration. Cloudy or discolored solution should be discarded.
Bayer also indicated that if the butterfly infusion set provided cannot be used, patients should contact their Kogenate® FS supplier and request a stand-alone filter compatible with Kogenate® FS products free of charge.
Questions can be directed to Bayer: 1.888.84-BAYER (22937), where a healthcare professional is available 24 hours a day.
Information provided by Bayer HealthCare
