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 if you have a history of anaphylactic or severe systemic response to immune globulin (Ig) preparations. If you suspect you are having a severe reaction to Vivaglobin^®, discontinue treatment immediately and inform your doctor.

Vivaglobin^® is derived from human plasma. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses and the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

In clinical trials, the most frequent adverse event was mild or moderate swelling, redness, and itching at the injection site. Other adverse events included headache, gastrointestinal disorder, fever, nausea, sore throat, and rash. No serious reactions were observed, and reactions tended to decrease substantially with repeated use.

If you are receiving Ig therapy for the first time, are new to Vivaglobin^®, or have not received Ig therapy within the past eight weeks, your healthcare provider should monitor your initial treatment with Vivaglobin^®, as you could experience reactions including fever, chills, nausea, and vomiting. Rarely, these reactions may lead to shock.

Ig administration may impair the effectiveness of virus vaccines, such as measles, mumps and rubella. Consult your doctor if you plan to receive any vaccine.

In clinical studies, Vivaglobin^® has been shown to be safe and well tolerated in pediatric patients, without pediatric-specific dose requirements. Safety and effectiveness were not studied in subjects under 2 years of age.

Please see full Prescribing Information and Patient Product Information.