Manage Immunoglobulin Patient Expectations with Subcutaneous Ig Therapy

You can help manage patients’ expectations about the Vivaglobin^® therapy by explaining the possible side effects up front

Understanding the most common potential side effects

Both intravenous immunoglobulin (IVIg) and subcutaneous (Sub-Q) immunoglobulin (Ig) have been approved by the FDA as effective treatments for primary immunodeficiency (PI). Patients report few serious side effects with Vivaglobin^®. Instead, the most common side effects from Vivaglobin^® are mild to moderate injection-site reactions.

These might appear as dime- to half dollar-sized areas of raised skin. When they occur, they may be associated with mild to moderate redness, itching, or discomfort. In moderate cases, the affected area can be tender and larger than a half dollar. Injection–site reactions are normal and easy to treat. They also tend to diminish in frequency the longer patients infuse the Sub-Q way—usually after 4 to 6 months.

A mild injection-site reaction is normal after an infusion. Over the course of 24 to 48 hours, these symptoms tend to decrease substantially. Their frequency also diminishes after approximately 4 to 6 months of Sub-Q Ig therapy.
A moderate injection-site reaction is normal after an infusion. Over the course of 24 to 48 hours, these symptoms tend to decrease substantially. Frequency diminishes after approximately 4 to 6 months of use.

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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

You can help manage patients’ expectations about the Vivaglobin® therapy by explaining the possible side effects up front

Important Safety Information

Please see accompanying full prescribing information for Vivaglobin®.

You can help manage patients’ expectations about the Vivaglobin^® therapy by explaining the possible side effects up front

Please see accompanying full prescribing information for Vivaglobin^®.