Steps to Starting PIDD Patients on Vivaglobin® Ig Therapy

The following information will assist you as you identify and initiate Vivaglobin^® therapy for your patients.

Step 1: Identify
The first step is to evaluate your patients with primary immune deficiency disease (PIDD) and determine which patients are good candidates for Vivaglobin^®.Vivaglobin^® offers a comparison to help you determine which PIDD patients will benefit most from Vivaglobin^®.

Step 2: Educate
Discuss Vivaglobin^® and Sub-Q self-administration with your patients and link them to educational resources such as the Vivaglobin^® Patient DVD on Vivaglobin.com, so they can understand how Sub-Q Ig therapy can fit their lives. Then you can help them evaluate their willingness to learn about and administer subcutaneous (Sub-Q) immunoglobulin (Ig) therapy.

Step 3: Refer
Refer your next PI patient to the Vivaglobin^® Resource Center by downloading the referral form or by calling: 1-877-VIVAGLOBIN (1-877-848-2456) for answers to many of their questions.

Next: Identifying 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

Important Safety Information

Please see accompanying full prescribing information for Vivaglobin®.

Please see accompanying full prescribing information for Vivaglobin^®.