Immune Deficiency Syndrome – Identifying Primary Immunodeficiencies

The term "primary immunodeficiency" refers to approximately 100 diseases that affect both children and adults. According to the Immune Deficiency Foundation (IDF) Web site, www.primaryimmune.org, as many as 1 in every 500 babies will be born with some form of PI. Some forms of PI, such as selective IgA deficiency (a relatively common form), are mild, bringing mild, often unnoticeable symptoms that can begin at any age. However, some forms of PI are very serious and life-threatening--affecting patients' quality of life and potentially their life expectancy.

The most frequently recognized PI-associated symptom is recurrent infections that fail to respond to traditional treatment. However, because some forms of PI never produce noticeable symptoms in some people (or don't produce them until later in life), and because many PI symptoms can seem unremarkable if they don't recur frequently, diagnosis can be difficult. In fact, a recent survey conducted by the IDF indicates that the average time lapse between onset of symptoms and accurate diagnosis of PI is a "staggering" nine years.

For a more complete understanding of PI, visit www.primaryimmune.org, which includes information on the many identified forms of PI disease.

Next: Living With PI

Important Safety Information

Immune Globulin Subcutaneous (Human), Vivaglobin^®, is a prescription treatment for patients with primary immunodeficiency (PI).

Immune globulin products, such as Vivaglobin^®, should not be taken if you have a history of anaphylactic or severe systemic response to immune globulin (Ig) preparations. If you suspect you are having a severe reaction to Vivaglobin^®, discontinue treatment immediately and inform your doctor.

Vivaglobin^® is derived from human plasma. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses and the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

In clinical trials, the most frequent adverse event was mild or moderate swelling, redness, and itching at the injection site. Other adverse events included headache, gastrointestinal disorder, fever, nausea, sore throat, and rash. No serious reactions were observed, and reactions tended to decrease substantially with repeated use.

If you are receiving Ig therapy for the first time, are new to Vivaglobin^®, or have not received Ig therapy within the past eight weeks, your healthcare provider should monitor your initial treatment with Vivaglobin^®, as you could experience reactions including fever, chills, nausea, and vomiting. Rarely, these reactions may lead to shock.

Ig administration may impair the effectiveness of virus vaccines, such as measles, mumps and rubella. Consult your doctor if you plan to receive any vaccine.

In clinical studies, Vivaglobin^® has been shown to be safe and well tolerated in pediatric patients, without pediatric-specific dose requirements. Safety and effectiveness were not studied in subjects under 2 years of age.

Please see full Prescribing Information and Patient Product Information.