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.