CSL Behring’s Helixate® FS and Mix2VialTM Now Packaged Together to Optimize Patient Safety and Convenience
King of Prussia, PA — 20 February 2007
CSL Behring has begun packaging
its advanced recombinant FVIII (rFVIII) factor product for the treatment of hemophilia A, with Mix2Vial™, its needle-free transfer device. The new packaging was developed in response to comprehensive market research of customers and to meet the latest Occupational Safety and Health Administration (OSHA) requirements.
“Since the introduction of Mix2Vial in 2005, our patients have experienced first-hand how user-friendly the device is compared to other transfer devices on the market,” said Robert Lefebvre Vice President, General Manager, U.S. Commercial Operations. “By packaging this technology together with Helixate FS and a 2.5 mL sterile water diluent that can be used for all potencies, we are providing patients, parents, and health professionals with a fast, simple and safe way to facilitate the mixing process.”
Before the availability of Mix2Vial, the reconstitution of Helixate FS required the use of a double-ended transfer needle, which increased patients’ and caregivers’ risk of accidental needlesticks. The Mix2Vial is an easy-to-use, plastic, needle-free transfer device with a built-in filter that works in conjunction with the 2.5 mL diluent to enable fast, easy infusions. New OSHA requirements now specify that all rFVIII products be made available in either a plastic needle-free transfer device or a pre-filled diluent syringe.
For more information about Helixate FS and Mix2Vial, 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 a more convenient administration by utilizing a 2.5-mL volume diluent, one of the smallest among available factor VIII products. Helixate FS does not use albumin in its purification or formulation and includes a solvent/detergent viral inactivation step. The most frequently reported adverse event was 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.
Introduced in 2005, the Mix2Vial™ is an easy-to-use, plastic, needle-free transfer device with a built-in filter. There is no handle to manipulate and no glass syringes. It is user-friendly, with color-coded end caps. The blue side goes to the diluent vial and the clear side to the Helixate® FS product vial. For nurses, pharmacists, patients, and others mixing products, the Mix2Vial is an efficient, convenient and easy-to-use alternative to existing transfer devices. (Mix2Vial is a trademark of Medimop Medical Projects, Ltd.)
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