Anaphylaxis is a rare but life-threatening complication of intravenous immunoglobulin (IVIg) therapy. Anaphylaxis can occur in any patient who receives IVIg therapy, even patients who are not identified as being at greater risk for reaction.
What Are Immunoglobulins?
Immunoglobulins are critical components of the immune system. Immunoglobulins are proteins that are produced in response to antigens, which are substances such as bacteria, viruses, or toxins that could cause harm to the body if left unchecked. An immunoglobulin recognizes an antigen as not being part of the body, and does everything it can to rid the body of the antigen.
There are several types of immunoglobulins. Each is produced in response to a specific perceived threat.
|Immunoglobulin A (IgA)||Protects against infections in the mucous membranes1|
|Immunoglobulin D (IgD)||Defends against airborne pathogens and upper respiratory infections2|
|Immunoglobulin E (IgE)||Recognizes and reacts to environmental allergens (e.g., pet dander, pollen, dust mites)3|
|Immunoglobulin G (IgG)||Protects against bacterial and viral infections in all body fluids, especially blood, lymph, cerebrospinal, and peritoneal fluids4|
|Immunoglobulin M (IgM)||Protects against infections in the blood and lymph, and is the first antibody to be produced in response to any threat5|
Sometimes the perceived threat isn’t a threat at all, and an immunoglobulin mistakenly attacks something beneficial to a patient—even the patient’s own cells. When this happens, it is called an autoimmune reaction. Disorders such as Crohn’s, lupus, and rheumatoid arthritis can result.
Sometimes a patient’s body doesn’t make enough antibodies, and replacement therapy is needed to increase the patient’s antibody levels. This may happen when a patient has a serious illness, such as cancer, or when a patient has a primary immunodeficiency. Some patients may require immune replacement therapy over the course of their illness; others will need it at various times throughout their life.
Immune globulin can be administered either intravenously (IVIG) or subcutaneously.
What Is IVIG?
Immune globulin is a biologic. It is created from the pooled plasma of thousands of blood donors. Although production processes are thorough and include screening and purification of the donated blood, there is still a slight risk that an infection or virus may sneak through. And with so many donors, there is greater likelihood that a patient may react to some other pathogen in the product.
Which IVIG Patients Are at Greatest Risk for Anaphylaxis?
Every patient undergoing IVIG therapy is at risk for anaphylaxis, but a few patient populations are particularly susceptible6, 7:
- Patients who previously experienced anaphylaxis when receiving IVIG
- Patients with IgA-deficiency with antibodies to IgA
Patients who previously experienced anaphylaxis when receiving IVIG may benefit from subcutaneous administration.8
For patients with IgA-deficiency, more care may be required. IVIG is almost entirely comprised of IgG. However, small amounts of IgA and IgM are present. Amounts of IgA can range from trace amounts to 720 mcg/mL.9-11 In patients with Ig-A deficiency, a higher concentration of IgA in the IVIG could result in an anaphylactic reaction.
Although the risk of anaphylaxis is rare, it is imperative that you keep epinephrine close at hand.
Epinephrine Snap makes it easy to be prepared when you’re administering IVIG infusions. Each Epinephrine Snap kit contains:
- One epinephrine ampul
- Three blunt tip filter needles
- Three syringes
- Three safety needles
- Alcohol pads and labels
Epinephrine Snap is conveniently packaged to make dosing quick and easy. Each kit is intended for adult patients, single-use only. It is for use by licensed health care professionals authorized to administer prescription medication and is only available by prescription.
Order through our website or contact your preferred GPO or distributor. Use NDC 24357-911-01.
1 Immune Deficiency Foundation. https://primaryimmune.org/about-primary-immunodeficiencies/specific-disease-types/selective-iga-deficiency/
2 Chen K, Cerutti A. The Function and Regulation of Immunoglobulin D. Current opinion in immunology. 2011;23(3):345-352. doi:10.1016/j.coi.2011.01.006. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3109135/
3 American Academy of Allergy, Asthma & Immunology. https://www.aaaai.org/conditions-and-treatments/conditions-dictionary/immunoglobulin-e-(ige)
4 Affymetrix Ebioscience. https://www.ebioscience.com/knowledge-center/antigen/immunoglobulin/igg.htm
5 Blood Test: Immunoglobulins (IgA, IgG, IgM). https://kidshealth.org/en/parents/test-immunoglobulins.html
6 Gammaplex Package Insert. https://www.fda.gov/downloads/biologicsbloodvaccines/ucm182963.pdf
8 Skoda-Smith S, Torgerson TR, Ochs HD. Subcutaneous immunoglobulin replacement therapy in the treatment of patients with primary immunodeficiency disease. Therapeutics and Clinical Risk Management. 2010;6:1-10. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2817783/
9 Comparison Chart: Intravenous Immune Globulin (10%). BDI Pharma.
10 Comparison Chart: Intravenous Immune Globulin (5% and Lyophilized). BDI Pharma.
11 Comparison Chart: IVIG Therapies. MedPro Rx Specialized Pharmacy Services. https://www.medprorx.com/forms/MedProRx_IVIg_chart.pdf