The Australasian Society of Clinical Immunology and Allergy

Also known as IVIG, SCIG, Antibody Replacement Therapy

Terms:

"Gammaglobulin" and "Immunoglobulin" are terms used to describe antibodies, which are vital        proteins produced by the immune system to deal with infections.
"Plasma" is the liquid part of blood that remains when all cells have been removed

Why is Immunoglobulin therapy used?

Many people with immunodeficiencies have insufficient antibodies to adequately fight infections. Immunoglobulin replacement therapy is one of the most important and successful therapies for these people, and can be life saving. Immunoglobulin replacement therapy can:

1. Treat existing infections
2. Prevent new infections from occurring
3. Prevent the long-term damage of chronic infections (for example bronchiectasis in the lung).

Immunoglobulin products in Australia include Intragam P®, Octagam® and Sandoglobulin®.

How is Immunoglobulin therapy made?

Immunoglobulin products are purified from pooled plasma of many healthy blood donors. When donors give blood samples, the red cells and plasma are separated. The plasma is pooled together and processed in highly specialised and regulated facilities to produce the product. Each preparation therefore contains a wide variety of antibodies.

How is it delivered to the patient?

There are two common ways that immunoglobulin replacement therapy can be delivered; intravenous (into the vein) and subcutaneous (under the skin).

1. Intravenous injections - at present intravenous immunoglobulin (IVIG) therapy is the most common means of immunoglobulin replacement therapy in Australia, New Zealand and through most of the world. Infusions are delivered directly into the vein, usually in a hospital day-stay clinic or sometimes in the patient's home. The infusion takes approximately two to four hours. The dose and frequency vary, and depend on the person's weight and immunoglobulin levels. Most people receive doses once every month.
2. Subcutaneous injections - the last few years has seen a move toward subcutaneous immunoglobulin (SCIG) injections, especially throughout Europe. This involves slowly infusing the antibody preparation directly under the skin, which can be done at home using a special pump. This is usually done once or more each week as only 10-15mL can be infused into any one site. However, a 10mL infusion can be delivered in half an hour. It may be necessary in some cases for infusions to be more frequent, particularly during introduction to therapy. When beginning SCIG therapy, red lumps may form under the skin. These usually disappear quite quickly and after a few weeks of therapy usually stop appearing.     

Are there any side effects of Immunoglobulin Replacement Therapy?

Immunoglobulin replacement therapies are normally very well tolerated and serious side effects are very rare. There are some side effects that you need to be aware of:

1. Risk of blood-borne infections
   As immunoglobulin preparations are derived from blood donors, there will always be a theoretical risk of blood borne infections. There has never been a case of HIV transmitted by this means. However, in the past, there have been cases of transmission of Hepatitis C and other viral illnesses. Transmission of Hepatitis C has not occurred in Australia or New Zealand. Current preventative measures have been greatly enhanced so that the risk of infection from antibody therapy is now close to zero. Nevertheless, you may wish to discuss this risk with your medical team.

2. Other side effects
   Some patients get minor side effects such as low-grade fevers or headaches which can usually be reduced by a slower infusion rate or treated with paracetamol. Occasionally patients experience hives or wheezing or rarely severe headaches. Rare cases of severe allergic-type reactions and abnormal kidney function have been described.

3. IgA reactions
   In rare cases, where the patient lacks the antibody called IgA, reactions similar to severe allergy may occur when receiving blood products containing IgA. However, the great majority of IgA deficient patients receive blood products without difficulty. These reactions are less likely with current IgA-depleted Immunoglobulin products.

You should notify your doctor of any side effects you might experience.

Limitations of Immunoglobulin Replacement Therapy

Antibody preparations contain essentially only one of the important components of the immune system's response to infection. This therapy does not cure the antibody deficiency, and will seldom reverse long-term organ injury from chronic infections. For this reason it is best to start before organ damage has occurred.

Availability of Immunoglobulin Therapy for Replacement

Changes in the way these products are supplied should reduce product shortages that have occurred in Australia in recent years. Such shortages have not been a problem to date in New Zealand.
Regardless of product availability, replacement therapy should be reserved for those patients with confirmed abnormalities in antibody production, and who experience recurrent infections.

Immunoglobulin therapy for other diseases

Immunoglobulin therapy is also of great benefit for patients with certain autoimmune diseases (immune thrombocytopenia, and Guillain Barre syndrome are examples), where it is used to alter the course of the disease (immuno-modulation) rather than to top-up antibodies (replacement) that are deficient. Immunoglobulin therapies should be used in these cases only where scientific evidence supports its use, and where other therapies are considered less favorable.

Is there any support for patients in Australia with Primary Antibody Deficiencies?

ASCIA has established a Register of patients with immune deficiency diseases so these conditions can be better understood and managed (http://www.immunodeficiency.org.au). Also The Immune Deficiency Foundation of Australia (IDFA) is part of an International Alliance to provide support for patients (www.idfapa.org). Further information can be provided if you are interested. Visit the ASCIA website or contact This e-mail address is being protected from spam bots, you need JavaScript enabled to view it

©ASCIA 2006
DISCLAIMER: This ASCIA Education Resources FACT SHEET has been peer reviewed by ASCIA members and represents the available products (in Australia and New Zealand) and published literature at the time of review.  It is important to note that information contained in this fact sheet is not intended to replace professional medical advice.  Any questions regarding a medical diagnosis or treatment should be directed to a medical practitioner.

Content Last updated 1 January 2006