IVIg Treatment Alternative for Patients with Primary Immunodeficiency

Vivaglobin 16% is the first and only 16% Sub-Q Ig therapy available for patients with primary immunodeficiency

How is PIDD treated?
Treating primary immunodeficiency disorders (PIDD), also known as primary immunodeficiencies (PI) involves supplying the body with replacement immunoglobulin (Ig) to help prevent infections throughout the body.

Treating infections
A wide variety of powerful antibiotics are available, and doctors can prescribe the right ones to combat the specific germs involved in an infection. Other common medicines, like aspirin and ibuprofen, are used to relieve fevers and body aches.

Ig therapy options
Depending on the type of PIDD, some people can benefit from "infusions" of a naturally occurring antibody called immunoglobulin, or simply, Ig. These infusions can be given two ways.

The first way is through a vein in the arm; this is called "intravenous Ig" or "IVIg" treatment. Since IVIg must be administered by trained healthcare personnel in most situations, patients may need to receive their IVIg treatments at infusion clinics, hospitals, their physician’s office, or in a home-care setting. The ability to give larger volumes per IVIg infusion allows intermittent dosing (every 21-28 days).

More recent advancements have created a second way to administer Ig therapy for PIDD patients who are looking for an alternative to IVIg treatment. This Ig is infused just below the skin; it's called "subcutaneous Ig" or "Sub-Q Ig" treatment. Sub-Q Ig replacement therapy with Vivaglobin^® can be self-administered on a weekly basis, allowing patients to schedule therapy around their busy lives instead of scheduling their lives around therapy.

Next: About Sub-Q Ig Treatment

Important Safety Information

Immune Globulin Subcutaneous (Human), Vivaglobin^®, is a prescription treatment for patients with primary immunodeficiency (PI).

Immune globulin products, such as Vivaglobin, should not be taken by individuals with a history of anaphylactic or severe systemic response to immune globulin (Ig) preparations. If you feel you are having a severe reaction, discontinue treatment immediately and inform your doctor.

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.

In clinical trials, the most frequent side effect was injection-site reaction, consisting of mild or moderate swelling, redness, and itching. No serious site reactions were observed, and reactions tended to decrease substantially after repeated use. Other adverse events, regardless of cause, included headache, gastrointestinal disorder, fever, nausea, sore throat, and rash.

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.

Ig administration may impair the effect of virus vaccines, such as measles, mumps and rubella. Before getting any vaccination, inform your doctor that you are using Vivaglobin.

In clinical studies, administration of Vivaglobin has been shown to be safe and well tolerated in pediatric subjects without adjusted dosing. Safety and effectiveness were not studied in children under 2 years of age.

Please see full prescribing information and patient product information.

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.

Treating PIDD

Important Safety Information