Primary Immune Deficiency Patient Therapy Chart for Sub-Q and IV Treatment

Identifying patients who are good candidates for Vivaglobin^®

Patients who move to the Sub-Q way come from many walks of life, and any patient group can be considered a candidate for Sub-Q Ig therapy. However, Vivaglobin^® has not been studied in children younger than 2. Furthermore, research studies and experience have identified patient characteristics that may indicate which patients may be most successful going beyond IV and moving to the Sub-Q way.¹

More than 2,500 US patients and/or their caregivers have been taught to administer Vivaglobin^®.¹ Many patients (or their caregivers) can easily learn to administer Vivaglobin^® therapy—often in just 4 to 6 training sessions.^2-4

Considerations for Patients with Primary Immune Deficiency Disease (PIDD) Who…

References:

Kittner JM, Grimbacher B, Wulfe W, Jäger B, Schmidt RE. Patients’ attitude to subcutaneous immunoglobulin substitution as home therapy. J Clin Immunol. 2006;26:400-405.
Gardulf A, Nicolay U, Math D, et al. Children and adults with primary antibody deficiencies gain quality of life by subcutaneous IgG self-infusions at home. J Allergy Clin Immunol. 2004;114:936-942.
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.
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: Educating Patients

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

Identifying patients who are good candidates for Vivaglobin®

Important Safety Information

Please see accompanying full prescribing information for Vivaglobin®.

Identifying patients who are good candidates for Vivaglobin^®

Please see accompanying full prescribing information for Vivaglobin^®.