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FDA Approves Room Temperature Storage of ZLB Behring's Helixate® FS

FDA Approves Room Temperature Storage of ZLB Behring's Helixate® FS

King of Prussia, PA — 07 October 2005

ZLB Behring announced today that Helixate® FS has received approval to be stored at room temperature (up to 25°C, 77°F) for three months. The new storage guidelines for the treatment will provide users with greater flexibility and simplify storage options.

The United States Food and Drug Administration (FDA) approved the storage labeling change based on data from testing to assure the labeled potency (number of recombinant FVIII units contained in a vial) remains within specified limits through the expiration date of the product. The room temperature storage option is expected to be a significant convenience for Helixate® FS users.

"This is great news to moms like me," said Rhonda Boni-Burden, mother of a child with hemophilia A. "This will allow greater flexibility when traveling and while attending sporting events. This really is a welcome convenience."

Starting in November 2005, each package of Helixate® FS will include a special notification with details on the new labeling. While the new room temperature storage option may be used, ZLB Behring recommends refrigerating (2° - 8°C, 36° - 46°F) Helixate® FS whenever possible.

Please refer to the current full prescribing information for Helixate® FS for complete product information. If you have additional questions, please contact ZLB Behring Medical Information at 1-800-504-5434 or visit CSL Behring (Global).

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 reactions. Known hypersensitivity to mouse or hamster protein may be a contraindication to the use of Helixate® FS. For additional details, see current full prescribing information.

About Hemophilia

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 ZLB Behring

ZLB Behring is a global leader in the plasma protein biotherapeutics industry. Dedicated to improving the quality of life for patients throughout the world, ZLB Behring provides safe and effective plasma-derived and recombinant products and offers patients a wide range of related services. The company’s broad portfolio of life-saving therapeutics is used in the treatment of individuals with hemophilia and other bleeding disorders, immune deficiency disorders and inherited emphysema; the prevention of hemolytic diseases for the newborn; cardiac surgery patients; and shock and burn victims. Additionally, ZLB Behring operates one of the world’s largest, fully-owned plasma collection networks. ZLB Behring is a subsidiary of CSL Limited, a bio-pharmaceutical company, which operates worldwide from its headquarters in Melbourne, Australia. For more information, please visit CSL Behring (Global).


Sheila A. Burke
Director, Communications & Public Relations
Worldwide Commercial Operations
ZLB Behring
CRP16-05-0001 05/2016
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