News Release

Infusion nurses examine need for standards of practice in immunoglobulin therapy

As use of life-saving therapy expands, need arises for consensus on treatment protocol

Peer-Reviewed Publication

Edelman Public Relations, New York

King of Prussia, PA--August 12, 2005--A review article published in the July/August 2005 Journal of Infusion Nursing examines the need for established treatment guidelines to support doctors and nurses in correctly dosing and administering intravenous immunoglobulin (IVIG) as replacement therapy in patients with primary immunodeficiency (PI) disorders, who do not produce adequate levels of antibodies essential in fighting infectious diseases.1

Immunoglobulin (IG) is a life-sustaining, blood plasma-derived product that has become standard immune replacement therapy for most people living with PI. Even as the use of IVIG therapy continues to expand, formal consensus is lacking within the medical community on the appropriate dosing and frequency of IVIG, according to the authors of the article.

The infusion therapy nursing specialists who authored the Journal of Infusion Nursing article, titled, "Developing Practice Guidelines for the Administration of Intravenous Immunoglobulin," offer an in-depth examination of all aspects of IVIG treatment, including the benefits and risks, and the roles of physicians, nurses and patients in achieving best results from therapy, as well as a comprehensive look at the expanding use of IVIG therapy and the associated clinical challenges.

"Infusion nurses play a crucial role in making sure every patient gets the most effective dose on the proper schedule," said Jardiolyn Valino Patterson, RN, BSN, coauthor of the article and Clinical Coordinator for the Neurology Ambulatory Center at University of Maryland in Baltimore. "Since every patient is unique and many respond differently to different IVIG products, it is essential that we help develop and implement the dosing guidelines that will assure all patients maximum benefit and minimal risk."

Primary immunodeficiency encompasses more than 100 distinct inherited disorders that strike at the body's ability to fend off infection.2 IG replacement therapy can be life-saving and offers substantially improved health and quality of life for most living with a PI disorder.

Globally, IG treatments can be administered by intravenous infusion, intramuscular injections, or subcutaneous infusion. In the US, intravenous administration is currently the most common mode. However, as many as one-fourth of all PI patients have problems with IVIG because of poor access to veins or severe side effects from the therapy.3 Another option is administering IG subcutaneously, or under the skin (SC). In Europe, SCIG has been approved and is regularly used for certain indications. In the Scandinavian countries, particularly Sweden, the SC route of administration has been widely adopted.

Although SCIG must be given more frequently than IVIG, clinical trials have demonstrated that it can be self-administered at home without the assistance of a doctor or nurse.4 "Increased use of SCIG therapy further raises the need for proper guidelines and dosing protocols," said Valino Patterson, "and Infusion Nurses, working with physicians and patients, are important in ensuring the best possible immune replacement therapy for all those who depend on it for healthy lives."

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The Journal of Infusion Nursing is the official publication of the Infusion Nurses Society.

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; for the prevention of hemolytic diseases for the newborn; in cardiac surgery patients; and in 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 biopharmaceutical company, which operates worldwide from its headquarters in Melbourne, Australia. For more information, please visit www.ZLBBehring.com.

Contact:
Sheila A. Burke
Director, Communications & Public Relations
Worldwide Commercial Operations
ZLB Behring
610-878-4209
Sheila.Burke@zlbbehring.com

1. Murphy, E, et al. Developing Practice Guidelines for the Administration of Intravenous Immunoglobulin. Journal of Infusion Nursing, Vol. 28, No. 4, July/August 2005. pp.266.

2 Lindegren ML, et al. Applying public health strategies to primary immunodeficiency diseases: a potential approach to genetic disorders. MMWR Recomm Rep. 2004 Jan 16; 53(RR-1):1-29.

3 Gardulf A., Hammarstrom L and Smith CI. Home treatment of hypogammaglobulinaemia with subcutaneous gammaglobulin by rapid infusion. Lancet.1991 Jul 20; 338(8760): 162-166.

4 Berger M. Subcutaneous immunoglobulin replacement in primary immunodeficiencies. Clinical Immunology. 2004 Jul; 112(1):1-7.


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