Living with Primary Immunodeficiency (PI) - What to Tell Your Child’s Teachers

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

If your school-age child has Primary Immunodeficiency (PI), it’s important for teachers, school nurses, and administrators to understand the condition and its treatment.

You can download a sample letter and add your own personalization to send to your child’s educators.

Help educators understand PI

Explain that PI stands for “Primary Immunodeficiency”—a genetic condition that people are born with
Be sure to explain that PI is not contagious and cannot be spread to other children or adults. Sometimes, when some people hear the word “immunodeficiency,” they think of the AIDS virus, which is a secondary immunodeficiency. You can reassure others that your child poses no risk to other children
Clarify that other children can affect the health of your child
Describe how common germs can be especially detrimental—even life-threatening–to your child’s health
Let the educators know that your child can participate in normal classroom and playground activities

Ask educators to help minimize your child’s exposure to germs

Solicit the educator’s help in encouraging sick children to refrain from school attendance
Request that classmates who do come to school ill will be sent to the nurse’s office, sent home, or relocated to the opposite side of the classroom
Appeal to the educator to reinforce good hygiene practices, encouraging children to wash their hands after sneezing, blowing their noses, or using the washroom

Request that educators be alert to potential problems

Ask educators to contact you if your child appears overly tired, feverish, or chilled. In particular, your child may be susceptible to upper respiratory infections, such as sinus, ear,and bronchial infections, and even pneumonia. Symptoms of these might include, for example, a cough, congestion, runny nose, earache, or difficulty breathing
Likewise if your child complains of a headache, sinus pain, fatigue, or difficulty breathing, the school personnel should contact you
Let the educators know that local injection-site reactions may occur up to 48 hours after an infusion and are normal–particularly in people who are new to the Sub-Q way. Explain that these local reactions should dissipate with time and are only abnormal if they become increasingly red, warm to the touch, painful, or if your child develops a fever

Next: How to Talk to Other Family Members and Friends

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.

How to Talk to Educators

Important Safety Information for Vivaglobin

Important Safety Information for Hizentra