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CSL Behring’s Innovative HeliTrax(SM) System Helps Physicians Manage Hemophilia A Patients

August 25, 2008 by Rx Times  
Filed under Rx News

    KING OF PRUSSIA, Pa., Aug. 25 — Hemophilia A patients who
use Helixate(R) FS, Antihemophilic Factor (Recombinant), and their
treatment providers are now tracking treatment progress in real time,
thanks to the HeliTraxSM System, a state-of-the-art wireless Internet-based
data management system recently introduced by CSL Behring. The system
allows for a comprehensive view of a patient’s progress, with young
patients relaying information about bleeding events and their use of
Helixate FS to their hemophilia treatment center via the handheld device
between office visits. The HeliTrax System, used in conjunction with
Helixate FS treatment, is designed to improve patient-physician
communications and therapy management.

    “HeliTrax provides clinicians with the rapid, comprehensive clinical
view they need to make assessments about treatment, it eliminates paperwork
and helps to streamline patient data management,” says Jill Leone, RN,
CCRP, a hematology nurse who helped develop the system. “For young
patients, HeliTrax helps them keep in touch with their therapy and
motivates them to stay on track.”

    Physicians monitoring hemophilia A patients previously relied on paper
forms filled out by the patients or their caregivers, which did not always
provide necessary clinical information in a timely, clear and concise way.
HeliTrax not only tracks a patient’s therapy as it happens — including
medication usage and inventory — but allows the hemophilia treatment
center to generate a one-page, easy-to-read, full-color clinical report of
the patient’s progress. These private, secure reports, which help reduce
documentation and transcription errors, are compliant with both the Joint
Commission on Accreditation of Healthcare Organizations (JCAHO) and the
Health Insurance Portability and Accountability Act (HIPAA). Additionally,
the system is backed up every 48 hours, ensuring that the patient’s
complete record is saved. CSL Behring has no access to patient data and all
data are managed by a third-party company.

    HeliTrax is also equipped with a camera to document bleeding events.
Patients can quickly capture a high-quality picture of the bleed, which can
then be seamlessly transmitted electronically to their treatment team, who
can assess the seriousness of the event and often save the patient from
making unnecessary trips to the emergency room.

    “This innovative device uses cutting-edge technology to help those
living with a bleeding disorder to manage their condition,” said Garrett E.
Bergman M.D., Senior Director of U.S. Medical Affairs at CSL Behring. “CSL
Behring is committed to the bleeding disorder community and continues to
develop creative management tools with the patient in mind.”

    Hemophilia primarily affects young males and managing their disease can
be challenging for them and their parents. Shirley Smith of Hariman,
Tennessee, has been using the HeliTrax System to manage her 10-year-old son
Tyler’s severe hemophilia and Factor VIII deficiency since October 2007.

    “I love it,” says Smith. “As complicated as things are when you have a
child with hemophilia, the HeliTrax System just makes life 150 percent
easier.”

    For more information about Helixate FS and HeliTrax please go to
http://www.cslbehring.com or call CSL Behring Consumer Affairs at 1-888-508-6978.

    About Helixate(R) FS

    Helixate(R) 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 2000 IU 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 packaged with 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.

    Helixate(R) FS is manufactured by Bayer HealthCare LLC for CSL Behring
LLC.

    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 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 disease
of 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 http://www.CSLBehring.com.

    Contact:

    Sheila A. Burke, Director, Communications & Public Relations
    Worldwide Commercial Operations
    CSL Behring
    610-878-4209
    Sheila.Burke@cslbehring.com

SOURCE CSL Behring

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