BERKELEY, Calif., June 29 /PRNewswire/ -- Bayer HealthCare announces today the availability of a new 2000 IU (international unit) vial size in the United States for hemophilia A patients treated with Kogenate(R) FS, Antihemophilic Factor (Recombinant), and Kogenate(R) FS Antihemophilic Factor (Recombinant), with BIO-SET(R), a Needleless Reconstitution System.
The 2000 IU vial size reduces reconstitution time by eliminating the need to mix and pool multiple vials for some patients requiring higher doses. The increased vial size also includes a new one-cut stopper and vial designed to simplify handling of reconstituted Kogenate FS.
“By reducing reconstitution time, the new 2000 IU vial size aims to make it easier for patients to be compliant with their prescribed treatment,” says Terry Tenbrunsel, Vice President, Sales and Marketing, Bayer HealthCare. “The 2000 IU vial size of Kogenate FS demonstrates Bayer HealthCare’s commitment to developing product enhancements that allow people living with hemophilia A to lead a better life.”
To further enhance the ease and convenience of treatment for hemophilia A patients, Bayer HealthCare also introduced Grab & Go packaging for Kogenate FS with BIO-SET. The new packaging contains all the elements necessary for safe and fast rFVIII infusion in a very small box: BIO-SET reconstitution system integrated with Kogenate FS, prefilled diluent syringe, BD Safety-Lok (TM) butterfly infusion set, plus alcohol swabs, cotton pad and latex-free bandage. Grab & Go packaging will debut with the 2000 IU vial size, and soon will be available for 250, 500, and 1000 IU vial sizes of Kogenate FS with BIO-SET. The Grab & Go packaging is part of Bayer HealthCare’s commitment to improve patient convenience and encourage treatment compliance.
Patients interested in trying Kogenate FS with the new 2000 IU vial size can enjoy immediate access by signing up for the Kogenate FS with BIO-SET Free Trial Program. The program gives individuals with hemophilia A in the United States* a one-time opportunity to experience treatment with Kogenate FS with BIO-SET, now featuring the 2000 IU vial size. Program enrollees receive a maximum of six free infusions of Kogenate FS with BIO-SET and the accompanying support programs and services available through Bayer HealthCare.
The Kogenate FS line of products includes the following via sizes: 250, 500, 1000 and 2000 IU. All but the 2000 IU vial sizes are provided with 2.5 mL of diluent; the 2000 IU vial size of Kogenate FS is reconstituted with 5 mL of diluent.
About Kogenate(R) FS
Kogenate(R) FS, Antihemophilic Factor (Recombinant), is a recombinant factor VIII treatment indicated for the treatment of hemophilia A. The most frequently reported adverse events were local injection site reactions, dizziness and rash. Known intolerance or allergic reactions to constituents of the preparation is a contraindication to the use of Kogenate(R) FS. Known hypersensitivity to mouse or hamster protein may be a contraindication to the use of Kogenate(R) FS. Please see the full prescribing information for important risk and use information at http://www.kogenatefs.com.
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.(1)
About Bayer HealthCare LLC
Bayer HealthCare LLC is an affiliate of Bayer HealthCare AG, one of the world’s leading, innovative companies in the healthcare and medical products industry based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. The Pharmaceuticals division comprises the following business units: Women’s Healthcare, Diagnostic Imaging, Specialized Therapeutics, Hematology/Cardiology, Primary Care, and Oncology. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating diseases.
Forward-looking statements
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group 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 our public reports filed with the Frankfurt Stock Exchange and the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
* Please note that patients who have previously received product through the Kogenate FS Free Trial Program or who are currently receiving Kogenate FS or Kogenate FS with BIO-SET therapy, or patients covered in whole or in part by federal or state health care programs, such as Medicare or Medicaid, are not eligible for the Kogenate FS with BIO-SET Free Trial Program.
(1)
http://www.hemophilia.org/NHFWeb/MainPgs/MainNHF.aspx?menuid=180&contentid=45&
rptname=bleeding
BAYER, the Bayer Cross, and Kogenate are trademarks of Bayer. (C)Bayer HealthCare LLC 09677Y BIO-SET is a trademark of Biodome SAS. BD Safety-Lok is a trademark of Becton, Dickinson and Company.
Bayer HealthCare
CONTACT: Sreejit Mohan of Bayer HealthCare, +1-510-705-5477,Sreejit.mohan@bayer.com
