Children with Primary Immunodeficiency can Infuse Vivaglobin®

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

Administering Vivaglobin^® to your child can be simple,¹ but children have
special needs

Moving to Vivaglobin^® can be a good option for children with PI, because infusions can occur at home using a portable pump. At the same time, children require special attention to help them understand how their Vivaglobin^® therapy will work and what will happen during an infusion.

You’ll receive comprehensive training on Sub-Q administration for your child. The techniques are simple to learn, and your healthcare professionals can show you this step-by-step process. Your comfort level with administering Vivaglobin^® will help put your child at ease.

Vivaglobin^® is infused subcutaneously into the fatty tissue just below the skin. Many children don’t have the body fat of adults, so a standard Sub-Q needle may be too large. However, Sub-Q needles are available in smaller sizes and styles that better accommodate the needs of children. Many children experience only a mild prick from the Sub-Q needle.

Before the first Vivaglobin^® infusion, talk to your child about what to expect with Vivaglobin^® therapy. Your confidence and calm reassurance can help ease any anxiety your child may have.

Click here to order a DVD that includes a step-by-step administration video, physician testimonial, and other important information about Vivaglobin^®.

References:

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: Potential Side Effects of Vivaglobin^®

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.

Administering Vivaglobin® 16% to Your Child

Important Safety Information for Vivaglobin

Important Safety Information for Hizentra

Administering Vivaglobin^® 16% to Your Child