Primary Immunodeficiency Organization and Advocacy Links

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

There are many organizations involved with PI. These organizations have Web sites covering specific topics related to PI. Two of the most helpful sites belong to organizations that help patients across the United States. They are the Immune Deficiency Foundation and The Jeffrey Modell Foundation.

These two organizations are very important to PI patients, and both offer special programs and educational opportunities for patients.

Information about PI
Immune Deficiency Foundation at www.primaryimmune.org

The Jeffrey Modell Foundation at www.jmfworld.com

In addition, the following resources may be helpful to you and your family.

National Primary Immunodeficiency Resource Center and the International Patient Organization for Primary Immunodeficiency at www.info4pi.org/

Federal organizations
Centers for Disease Control and Prevention, National Immunization Program at www.cdc.gov/vaccines/

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

National Institute of Allergy and Infectious Diseases at www3.niaid.nih.gov

National Institute of Health Web site at www.nih.gov

Patient advocacy and support organizations
National Organization for Rare Disorders at www.rarediseases.org

National Family Caregivers Association at www.nfcacares.org

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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.

Useful Links

Important Safety Information