Vivaglobin® is a Safe and Effective PIDD Treatment Based on Clinical Trials

Vivaglobin^®—Safe and Effective

Vivaglobin^® delivers documented subcutaneous (Sub-Q) safety. In clinical trials, patients experienced no serious systemic adverse events in more than 3,600 infusions of Vivaglobin^®.

In multicenter, open-label, prospective clinical studies conducted in the US and Canada, Vivaglobin^® administration has been shown to be safe and effective for people with primary immune deficiency disease (PIDD).

Most Frequent Adverse events by Infusion irrespective of causality in the Us and Canada

Please see the Important Safety Information below.

As with any medication, side effects may accompany Sub-Q Ig PIDD treatment. The most frequent adverse reaction is local injection-site reaction, which generally consists of mild or moderate swelling, redness, and itching. These injection-site reactions usually decrease within 24 to 48 hours after the infusion, and with repeated therapy, the frequency of injection-site reactions tend to decrease substantially.

No serious local injection-site reactions were observed during clinical study. The non-IND (investigational new drug) European/Brazilian clinical study also reported adverse events and rates similar to those in the North American study.

Vivaglobin^® is also preservative- and sucrose-free.

No serious local injection-site reactions observed during clinical study

Most Frequent related Adverse events by Infusion in the Us and Canada

Next: Dosing For Vivaglobin^®

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

Vivaglobin®—Safe and Effective

No serious local injection-site reactions observed during clinical study

Important Safety Information

Please see accompanying full prescribing information for Vivaglobin®.

Vivaglobin^®—Safe and Effective

Please see accompanying full prescribing information for Vivaglobin^®.