Vivaglobin® Clinical Trials Showed Low Annualized Rate of Infections in Study Subjects1

The efficacy of Vivaglobin^® has been demonstrated in an open-label, prospective, multicenter clinical study conducted in the United States and Canada. Vivaglobin^® is associated with low annualized rates of serious bacterial infections per subject per year.¹

In addition, a 6-month non-IND (investigational new drug) study of Vivaglobin^® in Europe and Brazil revealed results similar to the US/Canada study.²

Low annualized rate of infections with Vivaglobin^® per protocol subject

*Investigational new drug

In the North American (N=51) and European/Brazilian (N=47) clinical trial, low annualized rates of serious bacterial infections (SBIs): 0.04 SBIs per subject/year in each study (SBIs defined as bacterial pneumonia, meningitis, sepsis, osteomyelitis, and visceral abscesses)
In both clinical trials, low annualized rate of any infection: 4.4 infections per subject/year in North America (N=51) and 4.3 infections per subject per year in Europe/Brazil (N=47)

References:

Ochs HD, Gupta S, Kiessling P, et al. Safety and efficacy of self-administered subcutaneous immunoglobulin in patients with primary immunodeficiency diseases. J Clin Immunol. 2006;26:265-273.
Gardulf A, Nicolay U, Asensio O, et al. Rapid subcutaneous IgG replacement therapy is effective and safe in children and adults with primary immunodeficiencies—a prospective, multi-national study. J Clin Immunol. 2006;26:177-185.

Next: Vivaglobin^® Documented Safety

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^®.