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
