Immune Deficiency Syndrome – Identifying Primary Immunodeficiencies

Vivaglobin 16% is the first and only 16% Sub-Q Ig therapy available for patients with primary immunodeficiency

The term "primary immune deficiency syndrome", or "primary immunodeficiency disorders (PIDD)," 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 primary immune deficiency syndrome. Some forms of primary immune deficiency, such as selective IgA deficiency (a relatively common form), are mild, bringing mild, often unnoticeable symptoms that can begin at any age. However, other forms are very serious and life-threatening--affecting patients' quality of life and potentially their life expectancy.

The most frequently recognized PI-associated symptom associated with primary immune deficiency syndrome is recurrent infections that fail to respond to traditional treatment. However, because some forms of primary immune deficiency never produce noticeable symptoms in some people (or don't produce them until later in life), and because many primary immune deficiency 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 a primary immune deficiency syndrome is a "staggering" nine years.

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

Next: Living With PIDD

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 by individuals with a history of anaphylactic or severe systemic response to immune globulin (Ig) preparations. If you feel you are having a severe reaction, discontinue treatment immediately and inform your doctor.

Vivaglobin is derived from human plasma. 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 side effect was injection-site reaction, consisting of mild or moderate swelling, redness, and itching. No serious site reactions were observed, and reactions tended to decrease substantially after repeated use. Other adverse events, regardless of cause, included headache, gastrointestinal disorder, fever, nausea, sore throat, and rash.

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.

Ig administration may impair the effect of virus vaccines, such as measles, mumps and rubella. Before getting any vaccination, inform your doctor that you are using Vivaglobin.

In clinical studies, administration of Vivaglobin has been shown to be safe and well tolerated in pediatric subjects without adjusted dosing. Safety and effectiveness were not studied in children under 2 years of age.

Please see full prescribing information and patient product information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Identifying Types of PI

Important Safety Information