BioRx Offers Vivaglobin(R) To Patients With Primary Immune Deficiency Disorders

Main Category: Immune System / Vaccines
Article Date: 15 Nov 2007 - 2:00 PDT

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BioRx, a specialty pharmaceutical company, announces the availability of Vivaglobin(R) (immune globulin subcutaneous [human]), an immunoglobulin (ig) replacement therapy for treating patients with primary immune deficiency disorder (PIDD). PIDD is a group of usually-genetic disorders that compromise the immune system, leaving people vulnerable to recurrent, life-threatening infections. An estimated 50,000 Americans have PIDD.

BioRx is one of a small number of specialty pharmacies currently approved to dispense Vivaglobin®, which is manufactured and marketed by CSL Behring. Vivaglobin® is the first and only subcutaneous immunoglobulin replacement therapy approved by the FDA in the United States. Vivaglobin® delivers treatment directly under the skin (subcutaneously), offering a safe and effective alternative to intravenous infusions of immunoglobulin.

Mark Kestler, General Manager of BioRx, says "Recognition by CSL Behring as an approved Vivaglobin® provider validates BioRx as a leading quality provider of specialized pharmaceutical services. We are excited to be able to offer this valuable treatment option to our PIDD patients."

Until recently, PIDD patients needed to schedule appointments with a hospital, physician or homecare company to receive intravenous immunoglobulin treatment. Immunoglobulin is a life-sustaining blood product that is standard immune replacement therapy for most people living with PIDD. Approximately 70 percent of PIDD patients receive Ig replacement therapy, primarily intravenous immunoglobulin (IVIg), in which a pump delivers the immunoglobulin through a needle into a vein.

With Vivaglobin®, PIDD patients in the United States can now self-administer the treatment at home, with training from and the approval by their physician. The drug represents another treatment option for patients who may not easily tolerate the traditional intravenous method, because they have poor venous access or experience serious side effects from that method. Vivaglobin® also is appropriate for those who want the freedom and convenience of safe home self-administration of Ig replacement therapy.

This convenient treatment option will require education to help patients properly manage their own therapy. BioRx will provide patient training, as well as the drug, infusion pump, needles, tubing and any other supplies needed for treatment. 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. Typically, a patient requires approximately 3 or 4 educational sessions with a specially trained nurse before beginning self-administration independently.

Important Safety Information

As with all immune globulin products, Vivaglobin is contraindicated in individuals with a history of anaphylactic or severe systemic response to immune globulin preparations and in persons with selective IgA deficiency who have known antibody against IgA. If anaphylactic or anaphylactoid reactions are suspected, discontinue administration immediately and treat as medically appropriate.

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 completely eliminated.

In clinical trials, the most frequent adverse event 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 irrespective of causality included headache, gastrointestinal disorder, fever, nausea, sore throat, and rash.

As with all immune globulin products, patients receiving Ig therapy for the first time, receiving a new product, or not having received Ig therapy within the preceding eight weeks may be at risk for developing reactions including fever, chills, nausea, and vomiting. On rare occasions, these reactions may lead to shock. Such patients should be monitored in a clinical setting during the initial administration.

Ig administration can transiently impair the efficacy of live attenuated virus vaccines, such as measles, mumps and rubella.

In clinical studies, administration of Vivaglobin has been shown to be safe and well tolerated in both adult and pediatric subjects. No pediatric-specific dose requirements were necessary to achieve the desired serum IgG levels. Safety and efficacy were not studied in pediatric subjects under two years of age.

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.

http://www.cslbehring.com

About BioRx

Based in Cincinnati Ohio, BioRx is a national pharmacy specializing in highly customized care for the primary immunodeficiency diseases (PIDD) community. As one of the nation's fastest growing providers of IgG and other specialty pharmaceuticals, the company's clinical staff reaches patients and physicians in all 50 states.

http://www.biorx.net

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