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

Hypogammaglobulinemia (Congenital and Acquired)

Hypogammaglobulinemia, largely synonymous with the term "agammaglobulinemia", is an immune disorder that is characterized by abnormally low levels of all classes of immunoglobulins.

Hypogammaglobulinemia is a characteristic of common variable immunodeficiency (CVID); the most commonly encountered primary immunodeficiency disorder (PIDD). It is associated with heightened susceptibility to infectious diseases and many patients with hypogammaglobulinemia present with a history of recurrent infection.

Hypogammaglobulinemia may be caused by primary (congenital) or secondary (acquired) disorders. Congenital hypogammaglobulinemia may be tied to X-linked agammaglobulinemia, autosomal recessive agammaglobulinemia, hyper IgM syndromes, common variable immunodeficiency (CVID), isolated non-IgG immunoglobulin deficiencies, an IgG subclass deficiency, specific antibody deficiency (SAD), transient hypogammaglobulinemia of infancy, or immunodeficiency with thymoma. Congenital hypogammaglobulinemia treatment includes the use of immunoglobulin replacement therapy. Treatment for infections requires the use of antibiotics.

Combined T-cell and B-cell disorders associated with hypogammaglobulinemia include severe combined immunodeficiency (SCID), Wiskott-Aldrich syndrome, and Ataxia-telangiectasia (A-T). Secondary (acquired) diseases related to hypogammaglobulinemia include nephrotic syndrome, protein-losing enteropathy, catabolic disorders, immunosuppressive therapy, lymphoproliferative malignancies, premature birth, and the use of certain drugs. Acquired hypogammaglobulinemia treatment is usually directed at the underlying cause of the condition.

Vivaglobin^® is the first and only FDA-approved Sub-Q Ig replacement therapy available for patients with primary immunodeficiency disorders. Please see full Prescribing Information and Patient Product Information.

Please see Important Safety Information for Vivaglobin below.
Please see Important Safety Information for Hizentra below.

Important Safety Information for Vivaglobin

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.

Important Safety Information for Hizentra

Immune Globulin Subcutaneous (Human), Hizentra™, is indicated as replacement therapy for patients with primary humoral immunodeficiency (PI). This includes but is not limited to the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

Hizentra is contraindicated in patients with a history of anaphylactic or severe systemic reaction to human immune globulin preparations or components of Hizentra, such as polysorbate 80. Because it contains the stabilizer L-proline, Hizentra is contraindicated in patients with hyperprolinemia. Hizentra is also contraindicated in patients with immunoglobulin A deficiency who have known antibody against IgA and a history of hypersensitivity.

All IgA-deficient patients with anti-IgA antibodies are at greater risk of developing potentially severe hypersensitivity and anaphylactic reactions. If hypersensitivity occurs or anaphylactic reactions are suspected, discontinue administration immediately and treat as medically appropriate.

Hizentra 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.

The most common drug-related adverse reactions (observed in 5% or more of subjects in the clinical trial) were local reactions (ie, swelling, redness, heat, pain, and itching at the injection site), headache, vomiting, pain, and fatigue.

Monitor patients for reactions reported to occur with IVIg treatment that might also occur with Hizentra, including renal dysfunction/failure, thrombotic events, aseptic meningitis syndrome (AMS), hemolysis, and transfusion-related acute lung injury (TRALI).

Ig administration can transiently impair the efficacy of live attenuated virus vaccines, such as measles, mumps and rubella. It can also lead to misinterpretation of serologic testing.

No overall differences in safety or efficacy were observed in patients over 65 or in pediatric patients. In the clinical study, desired serum IgG levels were achieved in pediatric patients without pediatric-specific dose requirements.

Please read full Prescribing Information and Patient Product Information for Hizentra.

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.

Vivaglobin® 16% Resource Center

Hypogammaglobulinemia (Congenital and Acquired)

Important Safety Information for Vivaglobin

Important Safety Information for Hizentra

Vivaglobin^® 16% Resource Center