Primary Immune Deficiency Disease Professional Associations and Patient Advocacy

You can find helpful information about PI and its treatment options at the following links:

Professional associations
American Academy of Allergy, Asthma and Immunology (AAAAI)
www.aaaai.org

Clinical Immunology Society (CIS)
www.clinimmsoc.org/

Federation of Clinical Immunology Societies (FOCiS)
www.focisnet.org

Patient advocacy
Center for Biologics Evaluation and Research, FDA
www.fda.gov/cber/index.html

Centers for Disease Control and Prevention, National Immunization Program
www.cdc.gov/nip/

Genetic Alliance
www.geneticalliance.org

Immune Deficiency Foundation (IDF)
www.primaryimmune.org

International Patient Organization for Primary Immunodeficiencies (IPOPI)
http://www.ipopi.org

The Jeffrey Modell Foundation
www.jmfworld.com

National Family Caregivers Association (NFCA)
www.nfcacares.org

National Institute of Allergy and Infectious Diseases (NIAID)
www3.niaid.nih.gov

National Institutes of Health (NIH)
www.nih.gov

National Institute of Child Health and Human Development (NICHD)
www.nichd.nih.gov

National Organization for Rare Disorders (NORD)
www.rarediseases.org

National Primary Immunodeficiency Resource Center (info4pi.org)
www.info4pi.org/

Important Safety Information

Immune Globulin Subcutaneous (Human), Vivaglobin^®, is indicated for the treatment of patients with primary immunodeficiency (PI).

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 immunoglobulin A 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 (Ig) 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.

Please see accompanying full prescribing information for Vivaglobin^®.

Please see Patient Product Information

Please see full Prescribing Information

Important Safety Information

Please see accompanying full prescribing information for Vivaglobin®.

Please see accompanying full prescribing information for Vivaglobin^®.