Hemophilia A patients who require high doses of Helixate® FS, Antihemophilic Factor (Recombinant), can now benefit from greater convenience in administering their treatment, thanks to a new 3000 IU (international unit) dosage strength. CSL Behring announced today that this new dosage strength is available in the U.S., allowing many patients to reduce reconstitution time by eliminating the need to mix and pool multiple vials of Helixate FS.
"Treatment compliance and adherence are two challenges for people with hemophilia A and the healthcare professionals who help them manage their condition," said Garrett E. Bergman, M.D., Senior Director of Medical Affairs, U.S. Commercial Operations at CSL Behring. "The new 3000 IU dosage strength for Helixate FS is one more advancement that will encourage compliance with prescribed treatment by helping to shorten the time many patients spend infusing."
All dosage strengths of Helixate FS, including the new 3000 IU, are packaged with the Mix2Vial™. The Mix2Vial is an easy-to-use, plastic, needle-free transfer device with a built-in filter. Treatment can also be complemented by using HeliTraxSM , a wireless electronic data management system that can help improve patient-treatment team communications and therapy management.
"As an athlete, I lead an extremely active and busy lifestyle," said Jesse Schrader, a patient with hemophilia A, who plays competitive baseball. "The 3000 IU dosage strength for Helixate FS will help me save time, as I'll only have to use one vial to receive my therapy."
To provide dosing flexibility to healthcare professionals and people who are managing their hemophilia A, Helixate FS comes in a variety of dosage strengths: 250 IU, 500 IU, 1000 IU, 2000 IU and the new 3000 IU.
With more than 2.5 billion units infused to date, Helixate FS has been shown to be safe and effective in clinical studies as well as in post marketing use in the hemophilia community. For more information about Helixate FS, please visit www.HelixateFS.com or call CSL Behring Consumer Affairs at 1-888-508-6978.
Hemophilia is an inherited bleeding disorder characterized by prolonged or spontaneous bleeding, especially into the muscles, joints, or internal organs. About 15,000 Americans have hemophilia. The disease is caused by deficient or defective blood coagulation proteins known as factor VIII or factor IX. The most common form of the disease is hemophilia A, or classical hemophilia, in which the clotting factor VIII is either deficient or defective. Hemophilia B is characterized by deficient or defective factor IX.
About Helixate FS
Helixate FS is a recombinant factor VIII product indicated to control and prevent bleeding episodes in adults and children with hemophilia A. Helixate FS is also indicated for routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A with no preexisting joint damage.
The most serious adverse reactions with Helixate FS are systemic hypersensitivity reactions and the development of high-titer inhibitors necessitating alternative treatments to antihemophilic factor. 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.
Helixate 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.
Helixate FS offers convenient administration with a 2.5-mL volume diluent for most assay sizes; no available factor VIII product has a smaller diluent size. No albumin is used in the formulation or purification of Helixate FS, and its manufacture includes a solvent/detergent viral inactivation step.
Helixate FS can be stored at room temperature (up to 25°C, 77°F) for three months. The storage guidelines for the hemophilia treatment provide users with greater flexibility and simplify storage options.
Please visit www.helixatefs.com/prescribinginformation.aspx for full prescribing information.
Helixate® FS is manufactured by Bayer HealthCare LLC for CSL Behring LLC.
About CSL Behring
CSL Behring is a leader in the plasma protein therapeutics industry. Committed to saving lives and improving the quality of life for people with rare and serious diseases, the company manufactures and markets a range of plasma-derived and recombinant therapies worldwide. CSL Behring therapies are indicated for the treatment of coagulation disorders including hemophilia and von Willebrand disease, primary immune deficiencies and inherited respiratory disease. The company's products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic diseases in newborns. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. CSL Behring is a subsidiary of CSL Limited, a biopharmaceutical company headquartered in Melbourne, Australia. For more information, visit www.cslbehring.com.
Greg Healy, Senior Manager, Public Relations & Communications
U.S. Commercial Operations