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KING OF PRUSSIA, Pa., April 11 /PRNewswire-FirstCall/ — CSL Behring, a worldwide leader in developing subcutaneous immunoglobulin therapies, announced today the launch of a new program to educate healthcare providers and primary immunodeficiency (PI) patients on the proper technique for administering subcutaneous immunoglobulin therapy. The program, named VITAL(TM), an acronym for Vivaglobin Integrated Training And Learning, is being introduced to support the at-home use of Vivaglobin(R) (Immune Globulin Subcutaneous, Human), the first and only U.S. Food and Drug Administration- approved subcutaneous immunoglobulin (Ig) for treatment of patients with primary immunodeficiency. Vivaglobin was approved by the FDA on January 9, 2006.
Until recently, PI patients needed to schedule appointments with a hospital, physician or homecare company to receive intravenous immunoglobulin treatment. With the approval of Vivaglobin, a subcutaneous form of immunoglobulin, PI patients can now self-administer the treatment at home, given the approval of their physician. This new convenient treatment option will require education to teach patients how to properly manage their own therapy.
Through VITAL, CSL Behring offers nurses and physicians various tools and programs to assist them in teaching patients how to self-administer Vivaglobin at home.
“One of CSL Behring’s most important goals is to extend professional support and know-how well beyond the point of bringing high quality therapies to patients,” said Robert Lefebvre, general manager and vice president of U.S. Commercial Operations at CSL Behring. “We continually seek ways to ensure that consumers who choose our products understand how best to use them. The VITAL program is an excellent example of that commitment.”
All patients who start on Vivaglobin receive a patient starter kit to help manage their therapy. The kit includes helpful tools, such as administration guides, product information and a treatment journal.
Specialty pharmacies contracted to dispense Vivaglobin will provide patient training, as well as the drug, infusion pump, needles, tubing and any other supplies needed for treatment. Generally, the average patient requires approximately 4 or 5 educational sessions with a nurse before beginning self- administration independently.
Healthcare providers interested in requesting the VITAL educational program or related materials can access them through the Web site at http://www.Vivaglobin.com.
Vivaglobin is delivered directly under the skin via a small portable pump. In clinical trials, Vivaglobin was shown to be a safe and effective immunoglobulin replacement therapy for treating patients with PI. The trials also assessed patients for health-related quality of life through at-home self-administration and reported increases in general health with patients expressing a preference for SC administration over IV administration.
Vivaglobin is derived from human plasma. As with all plasma-derived products, the risk of transmission of infectious agents including viruses and – theoretically, the Creutzfeldt-Jakob disease (CJD) agent – cannot be eliminated completely.
The most frequent adverse event reported in clinical trials was injection- site reaction, consisting of mild or moderate swelling, redness and itching. No serious local site reactions were observed and reactions tended to decrease substantially after repeated use. Other adverse events included headache, gastrointestinal disorder, fever, nausea, sore throat and rash. Full prescribing information about Vivaglobin is available at http://www.Vivaglobin.com.
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.
Source: CSL Behring
CONTACT: Sheila A. Burke, Director of Communications & Public Relation
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