CSL Behring's Helixate® FS Now Available in 2000 IU Vial Size to Improve Patient Convenience, Encourage Compliance
King of Prussia, PA — 21 December 2007
CSL Behring today announced that Helixate® FS, its advanced recombinant FVIII (rFVIII) product for the treatment of hemophilia A, is now available in the United States in a new 2000 IU (international unit) vial size. For patients requiring high doses of Helixate FS, the 2000 IU vial size reduces reconstitution time by eliminating the need to mix and pool multiple vials.
"Helixate FS, with the new 2000 IU vial, offers patients shorter infusion times, which translates into greater convenience, and will encourage compliance with prescribed treatment," said Robert Lefebvre, vice president and general manager, U.S. Commercial Operations. "The introduction of the 2000 IU vial is a solid example of CSL Behring's ongoing commitment to advancing hemophilia therapy management and improving convenience for patients."
Use of Helixate FS in conjunction with CSL Behring's new HeliTraxSM system can improve patient-physician communication and therapy management. The HeliTrax system combines an Internet-based encrypted database for professionals to track treatment and a wireless hand-held electronic diary for patients to log infusions and treatments with recombinant FVIII Helixate FS.
"Combining Helixate FS with HeliTrax may be ideal for the active, growing teen with hemophilia A who needs more factor product," said Jill Leone, RN, CCRP, nurse consultant. "Enhancing the system with the 2000 unit vial dosage will further improve convenience and communication, and enable teens to begin to manage the disease independently."
Helixate FS is packaged with the Mix2Vial, an easy-to-use, plastic, needle-free transfer device with a built-in filter. Use of the Mix2Vial helps minimize the risk of injury and reduces product preparation time.
For more information about Helixate FS and the 2000 IU vial, please visit www.cslbehring.com or call CSL Behring Consumer Affairs at 1-888-508-6978.
About Helixate® FS
Helixate® FS is a recombinant factor VIII treatment for hemophilia A that offers convenient administration with a 2.5-mL volume diluent; no available factor VIII product has a smaller diluent size. The new 2000 vial size requires a 5.0 mL volume diluent.
No albumin is used in the formulation or purification of Helixate FS, and its manufacture includes a solvent/detergent viral inactivation step. The most frequently reported adverse event is local injection-site reaction. Known hypersensitivity to mouse or hamster protein may be a contraindication to the use of Helixate FS. In 2006, the FDA gave approval for Helixate FS to be stored at room temperature (up to 25°C, 77°F) for three months. The new storage guidelines for the treatment provide users with greater flexibility and simplify storage options.
Helixate® FS is manufactured by Bayer HealthCare LLC for CSL Behring LLC.
Hemophilia is an inherited bleeding disorder characterized by prolonged or spontaneous bleeding, especially into the muscles, joints, or internal organs. About 17,000 Americans have hemophilia. The disease is caused by deficient or defective blood coagulation proteins known as factor VIII or IX. The most common form of the disease is hemophilia A, or classic hemophilia, in which the clotting factor VIII is either deficient or defective. Hemophilia B is characterized by deficient or defective factor IX.
About CSL Behring
CSL Behring is a global leader in the plasma protein biotherapeutics industry. Passionate about improving the quality of patients' lives, CSL Behring manufactures and markets a range of safe and effective plasma-derived and recombinant products and related services. The company's therapies are used in the treatment of immune deficiency disorders, hemophilia, von Willebrand disease, other bleeding disorders and inherited emphysema. Other products are used for the prevention of hemolytic diseases in the newborn, in cardiac surgery, organ transplantation and in the treatment of burns. The company also operates one of the world's largest plasma collection networks, ZLB Plasma. CSL Behring is a subsidiary of CSL Limited, a biopharmaceutical company with headquarters in Melbourne, Australia. For more information, visit www.cslbehring.com.
Sheila A. Burke
Director, Public Relations & Communications
Worldwide Commercial Operations