WAYNE, N.J., April 25, 2011 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has approved a new storage option for Kogenate® FS, antihemophilic factor (recombinant), now allowing the product to be stored at room temperature (up to 77 degrees F) for up to one year. Compared with the previous three-month room temperature option, this new storage option for Kogenate FS offers added convenience for patients with hemophilia A and is immediately available to customers.
Factor VIII products are typically stored in the refrigerator and are stable at room temperature for a limited time. With this new storage option, people who use Kogenate FS may have more flexibility for storing their medication whether they're at home or at school, at work or at play or when traveling. For some, the approval of this new storage option may free up refrigerator space or possibly eliminate the need for a separate "factor fridge."
"As convenience with medication is important to people with hemophilia A, we're pleased to offer a new storage temperature option, which complements other convenience features, including Grab and Go packaging with BIO-SET®, a compact and complete reconstitution system for Kogenate FS," said Paul Bedard, Vice President/General Manager, Hematology, Bayer HealthCare Pharmaceuticals. "This new option demonstrates Bayer's ongoing commitment to the hemophilia A community."
The starting date of room temperature storage for Kogenate FS should be clearly recorded on the unopened product carton. Once stored at room temperature, the product must not be returned to the refrigerator. The shelf-life then expires after the storage at room temperature (up to 12 months) or the expiration date on the product vial, whichever is earlier.
For additional information on Kogenate® FS, and the new and extended storage capabilities, please visit http://kogenatefs.com/webapp/prescribing-information.jsp.
About Hemophilia A
Hemophilia A, also known as factor VIII deficiency or classic hemophilia, is largely an inherited bleeding disorder in which one of the proteins needed to form blood clots in the body is missing or reduced. Hemophilia A, the most common type of hemophilia, is caused by deficient or defective blood coagulation proteins, known as factor VIII. Hemophilia A is characterized by prolonged or spontaneous bleeding, especially into the muscles, joints, or internal organs. Approximately one in 5,000 males born in the United States has hemophilia.
About Kogenate® FS
Indications and Usage
Kogenate® FS, antihemophilic factor (recombinant), is a recombinant factor VIII treatment 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 preexisting joint damage.
Important Safety Information
The most serious adverse reactions are systemic hypersensitivity reactions and the development of high-titer inhibitors necessitating alternative treatments to AHF. The most common adverse reactions observed in clinical trials were inhibitor formation in previously untreated or minimally treated patients, skin-associated hypersensitivity reactions, infusion site reactions, and central venous access device (CVAD) line-associated infections.
Kogenate® FS is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including mouse or hamster proteins.
For important risk and use information, please see the full Prescribing Information at www.kogenatefs.com/prescribing-information.jsp.
About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. As a specialty pharmaceutical company, Bayer HealthCare Pharmaceuticals provides products for Diagnostic Imaging, General Medicine, Hematology, Neurology, Oncology and Women's Healthcare. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.
This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
BAYER, the Bayer Cross and Kogenate are registered trademarks of Bayer.
BIO-SET is a registered trademark of Biodome SAS.
SOURCE Bayer HealthCare Pharmaceuticals Inc.