Vivaglobin®
Immune Globulin Subcutaneous (Human)
For primary immunodeficiency (PI) patients who are seeking an alternative to intravenous immunoglobulin therapy, new Vivaglobin
® is the first 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 as replacement therapy for patients with primary humoral immunodeficiency (PI). This includes but is not limited to the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.
Vivaglobin is contraindicated in patients with a history of anaphylactic or severe systemic reaction to the administration of human immune globulin preparations. Vivaglobin is also contraindicated in patients with immunoglobulin A deficiency with antibodies against IgA or a history of hypersensitivity.
Vivaglobin should be administered subcutaneously only. Do not administer intravenously.
Hypersensitivity reactions may occur. Patients with antibodies to IgA may have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions. If hypersensitivity occurs or anaphylactic 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.
The most common drug-related adverse reactions, observed in 5% or more of subjects in the clinical trial were local injection-site reactions (eg, swelling, redness, and itching), headache, nausea, rash, asthenia, and gastrointestinal disorders.
Aseptic meningitis syndrome (AMS) has been reported to occur infrequently with IVIg treatment and treatment with Vivaglobin. AMS is usually evidenced within 2 days of administration. Also monitor patients for other reactions reported to occur with IVIg treatment that might also occur with Vivaglobin, including renal dysfunction/failure, thrombotic events, hemolysis, and transfusion-related acute lung injury (TRALI).
Ig administration can transiently impair the efficacy of live attenuated virus vaccines, such as measles, mumps and rubella. It can also lead to misinterpretation of serologic testing.
Please see
full prescribing information.
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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: 17 October 2011