Immunology Therapy – Benefits of Sub-Q Ig for Patients with PIDD

Going beyond IV therapy

Since the 1980s, intravenous immunoglobulin (IVIg) has been the first-line therapy for most patients with primary immune deficiency disease who require Ig antibody replacement.^1,2 Experience has shown IVIg to be an efficacious, safe, life-saving treatment. Yet for some patients IVIg may not be the most appropriate immunoglobulin (Ig) therapy.

Vivaglobin^® is the first and only FDA-approved subcutaneous (Sub-Q) Ig therapy indicated for PIDD in the United States.

Please see the Important Safety Information below.

Sub-Q therapy can make a difference for patients and caregivers with busy, active lifestyles.^1,2

Sub-Q Ig therapy:

Offers patients the opportunity to self-administer immunoglobulin at home (with appropriate training), which may reduce interruptions in work, school, and social schedules
Allows patients to schedule treatments around their lives—not schedule their lives around appointments

Sub-Q therapy can make a difference for patients with poor venous access or who experience problems with IV therapy.^1,2

Sub-Q Ig therapy:

Avoids intravenous needle sticks
Eliminates the need for ports, peripheral lines, and IV poles
Reduces concerns about IV-related infections
Avoids intolerable adverse reactions during or following IV infusions^1,3
Maintains consistent, steady-state serum IgG levels without “wear off” effects^2,3

References:

Nicolay U, Kiessling P, Berger M, et al. Health-related quality of life and treatment satisfaction in North American patients with primary immunedeficiency diseases receiving subcutaneous IgG self-infusions at home. J Clin Immunol. 2006;26:65-72.
Ochs HD, Gupta S, Kiessling P, et al. Safety and efficacy of self-administered subcutaneous immunoglobulin in patients with primary immunodeficiency diseases. J Clin Immunol. 2006;26:265-273.
Gardulf A, Nicolay U, Asensio O, et al. Rapid subcutaneous IgG replacement therapy is effective and safe in children and adults with primary immunodeficiencies—a prospective, multi-national study. J Clin Immunol. 2006;26:177-185.

Next: About 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

Important Safety Information

Please see accompanying full prescribing information for Vivaglobin®.

Please see accompanying full prescribing information for Vivaglobin^®.