WHIPPANY, N.J., Oct. 3, 2013 /PRNewswire/ -- Bayer HealthCare announced today that the company is introducing Kogenate® FS antihemophilic factor (recombinant) with Vial Adapter. Vial Adapter is a reconstitution system designed to offer an additional choice for people with hemophilia A. Today's announcement was made at the National Hemophilia Foundation's annual meeting in Anaheim.
"Innovating in order to provide two reconstitution systems, Vial Adapter and BIO-SET®, is a great example of our commitment to delivering options that meet the needs of the entire hemophilia A community," said Pamela Cyrus, MD, Vice President and Head, U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals.
Vial Adapter is a needleless reconstitution system that contains a sterile chamber with a built-in 15-micrometer filter and a prefilled diluent syringe.
Both Kogenate® FS with BIO-SET® and Kogenate® FS with Vial Adapter are available in Grab and Go packaging, which includes:
- A prefilled diluent syringe
- The Terumo® SURFLO® Winged Infusion Set
- Alcohol swabs, a cotton pad and a latex-free bandage
- Exclusive anti-counterfeiting and tamper-evident features
Hemophilia advocate Michael Drab, who recently completed Bayer's Hemophilia Leadership Program, said, "When I first tried Vial Adapter, I found it to be quite intuitive." Another former Bayer Hemophilia Leadership Program intern, Christian Mund, commented, "I was impressed by Bayer's commitment to offering choices to their patients, and the Vial Adapter system is a great example of this."
INDICATIONS & USAGE
Kogenate® FS, antihemophilic factor (recombinant) is indicated for:
- Control and prevention of bleeding episodes in adults and children (0-16 years) with hemophilia A
- Peri-operative management in adults and children with hemophilia A
- Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in children with hemophilia A and to reduce the risk of joint damage in children without pre-existing joint damage
Kogenate® FS is not indicated for the treatment of von Willebrand disease.
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.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
For important risk and use information, please see the full prescribing information.
About Hemophilia A
Hemophilia A, also known as factor VIII deficiency or classic hemophilia is a largely inherited bleeding disorder in which one of the proteins needed to form blood clots in the body is missing or reduced. Hemophilia A is the most common type of hemophilia and is characterized by prolonged or spontaneous bleeding, especially into the joints, muscles or internal organs.
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, Medical Care and Pharmaceuticals divisions. As a specialty pharmaceutical company, Bayer HealthCare provides products for Cardiopulmonary Medicine, Hematology, Neurology, Oncology and W omen's Healthcare. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.
BAYER®, the Bayer Cross® and Kogenate® FS are registered trademarks of Bayer.
BIO-SET® is a registered trademark of Biodome SAS.
Terumo® and SURFLO® are registered trademarks of Terumo Medical Corporation.
Intended for U.S. Media Only
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.
SOURCE Bayer HealthCare