Vivaglobin®
Immune Globulin Subcutaneous (Human)
For primary immunodeficiency (PI) patients who are seeking an alternative to intravenous immunoglobulin therapy, new Vivaglobin
® is the first and only FDA-approved subcutaneous immunoglobulin for self-administration with physician’s approval.
Immune Globulin Subcutaneous (Human), Vivaglobin®, is indicated
for the treatment of patients with primary immune deficiency (PI).
NDC Number |
Product Description |
| 0053-7596-03 |
Box of ten 3 mL vials |
| 0053-7596-10 |
10 mL vial |
| 0053-7596-15 |
Box of ten 10 mL vials |
| 0053-7596-20 |
20 mL vial |
| 0053-7596-25 |
Box of ten 20 mL vials |
Important Safety Information
Immune Globulin Subcutaneous (Human), Vivaglobin®, is indicated for the treatment of patients with primary immunodeficiency (PI).
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. 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.
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
full prescribing information.
View universal billing codes for Vivaglobin®
CUSTOMER SUPPORT 1-800-683-1288 or
Customer Services
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.
Frequently Asked Questions for Vivaglobin®
To learn more about Vivaglobin®, please visit www.Vivaglobin.com
Last Updated: 23 September 2009