A: This product is a treatment option for patients with primary immunodeficiency (PI) who need or desire an alternative to intravenous immunoglobulin therapy. PI is a usually genetic group of disorders that compromise the immune system, leaving people vulnerable to often life-threatening infections. The Immune Deficiency Foundation estimates that as many as 1 in 500 Americans has been diagnosed some form of PI (mostly selective IgA deficiency). Taking into account all forms of PI, its incidence is roughly comparable to the incidence of leukemia in children.

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.

Q: How is PI diagnosed, and what are the warning signs?

A: PI can be diagnosed by a skin test similar to a tuberculosis test, or a blood test that measures the level of immunoglobins, the infection-fighting antibodies produced by white blood cells. Because the disease is generally inherited, prenatal genetic testing can also be performed. Most patients with PI are tested after complaining of multiple or recurrent infections; PI specialists say that people who suffer eight or more new ear infections in a year, have two or more sinus infections in a year, or who spend two or more months on antibiotics, are displaying warning signs and should be tested for PI. In addition, some forms of PI cause other, non-infection symptoms, including anemia and eczema. The average time from the onset of symptoms in individuals to diagnosis of PI is nine years.

To learn more about PI and treatment options, talk with your doctor and ask the experts at the Immune Deficiency Foundation and the Jeffrey Modell Foundation.

Q: How is Vivaglobin^® administered and for how long?

A: Vivaglobin^® is the first and only FDA-approved subcutaneous immunoglobulin (SCIg), meaning that with physician approval, Vivaglobin^® can be self-administered by patients through injection subcutaneously, or under the skin.

Vivaglobin^® is supplied as a sterile liquid designed to be injected subcutaneously, preferably in the abdomen, thighs, upper arms, and/or lateral hip. Vivaglobin^® must not be injected into a blood vessel.

In the clinical trial, all subjects who received Vivaglobin^® had previously been treated with intravenous immune globulin (IVIg). The prescribing information for Vivaglobin^® recommends that a patient start treatment with this product one week after receiving a regularly scheduled IVIg infusion.

Q: What differentiates Vivaglobin^® from other current treatments for PI?

A: Vivaglobin^® is the first and only subcutaneous (under the skin) immunoglobulin therapy available for PI patients in the U.S. Currently, the most common method of administering Ig in the U.S. is intravenously, or infusing into the vein. However, intravenous administration may not be optimal for all patients.

This product was designed to offer PI patients an alternative to intravenous immunoglobulin therapy, including, with a physician's training and approval, the option of self-administration.

Q: Why would I switch from intravenous to subcutaneous self-administration?

A: There are several reasons a patient might be interested in subcutaneous self-administration. With a subcutaneous immunoglobulin like Vivaglobin^®, you can self-administer your medication once you have your doctor's approval and training from a physician or healthcare provider. Self-administration lets you infuse at your convenience, at home, and while engaged in activities around the house. People with primary immunodeficiency who self-administer appreciate the greater mobility it allows, which is a stark contrast to that offered through pre-scheduled administration, whether in a medical setting or through a visiting nurse. Also, people with hard-to-find veins (called "poor venous access") like the idea that subcutaneous self-administration is through the skin, not into a vein. People who may experience intolerable side effects with intravenous infusions or who may experience a monthly "wear-off" effect right before their next scheduled IV infusion may also appreciate the benefits of Vivaglobin^®.

Q: Does subcutaneous self-administration with Vivaglobin^® work as well as intravenous immunoglobulin?

A: In a multicenter clinical trial conducted in the United States and Canada, Vivaglobin^® has been proven to be similarly effective to IVIg. In the trial, 65 patients with primary immunodeficiency who had previously been treated with monthly intravenous immunoglobulin were switched for a year to weekly subcutaneous administration with Vivaglobin^®. The trial showed that

A low annual rate of serious infections: 0.04 per subject per year
A low annual rate of infections overall: 4.4 per subject per year
A low annual rate of missed school and work days: 3.7 per subject per year
A low annual rate of days hospitalized due to infection, 0.23 per subject per year

The trial also showed that with weekly administration, serum levels of immunoglobulin or IgG in the bloodstream were steady unlike with monthly intravenous administration. Because Vivaglobin^® delivers steady serum Ig levels, people may not experience the "wear-off" effect that can occur for monthly intravenous therapy patients just before their next scheduled infusion.

Q: Is Vivaglobin^® safe?

A: The production of Vivaglobin^® involves multiple steps designed to ensure that it's safe. The production of Vivaglobin^® begins with donated human plasma. Each donation is accepted only after it has tested negative for viral markers such as Hepatitis A, B, and C viruses, Human immunodeficiency viruses types one and two, and Parvovirus B-19. Then, Vivaglobin^® undergoes rigorous processing to inactivate and/or remove potentially harmful viruses. These steps include cold alcohol processing and pasteurization by heating the solution at 60 degrees Celsius for 10 hours. As with all products made from human plasma, the risk of transmitting diseases can't be completely eliminated. However, CSL Behring goes to considerable lengths to remove and/or inactivate potential viruses in order to protect your safety.

Since 1994, when Vivaglobin^® began widespread use in Europe under a different brand name, no serious adverse events have been reported and there has never been a documented case of viral transmission from Vivaglobin^®.

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.

Q: Why are the steady serum levels of Vivaglobin^® so important?

A: With steady serum levels provided by weekly infusion, you may not experience the monthly "wear-off" effect that intravenous infusion patients may experience just before their next scheduled infusion.

Q: Are there adverse reactions or side effects that are common with Vivaglobin^®?

A: In the US and Canada clinical study, SCIg was evaluated in 65 subjects diagnosed with PI. 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.

Reactions similar to those reported with administration of other immune globulin products may also occur. Rarely, immediate anaphylactoid and hypersensitivity reactions may occur.

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.

Q: Are there possible drug interaction issues?

A: Immunoglobulin administration can transiently impair the efficacy of live attenuated virus vaccines, such as the measles, mumps and rubella vaccine. As with other Ig therapy, patients should inform their immunizing physicians of recent therapy with any Ig product so that appropriate precautions can be taken.

Q: Did patients overall prefer SCIg treatment to IVIg treatment?

A: According to a 36-question survey conducted in the Canadian and the non-IND European clinical studies, 80% of the patients in the Phase III clinical trial preferred SCIg treatment to IVIg. Often-cited reasons for the preference of SCIg included greater independence, better therapy convenience, less interference with work and/or school and lower travel costs.

Q: What kind of support is available for me and my family?

A: CSL Behring, the manufacturer of Vivaglobin^®, provides comprehensive educational materials, including a patient starter kit. We can also help you identify managed care reimbursement opportunities and financial assistance if you're uninsured. For assistance, please call the Vivaglobin^® Resource Center at 1-877-VIVAGLOBIN or 1-877-848-2456.

Important Safety Information

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.

Full Prescribing Information for Vivaglobin^®

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