Adverse events associated with IVIg can be characterized as (1) early systemic events, (2) infectious disease transfer, and (3) high-dose treatment-related adverse effects.

Early Systemic Events

Common transfusion-related early events are listed in Table1. Most early events are self-limiting and infusion rate dependent. Premedication with steroids, aspirin, or acetaminophen and antihistamines (such as diphenhydramine and the H2 blocker famotidine) often decreases symptoms. Prophylaxis with propranolol can be effective for induced migraine. Aseptic meningitis is a rare early event, is observed 1 to 2 days postinfusion, is unrelated to infusion rate, and can be treated with intravenous steroids and analgesics.

Table1. Early Systemic Adverse Events Associated With Intravenous Immunoglobulin Infusion

The frequency of reported adverse events varies considerably, ranging from 10% to 85%. There are many reasons for this high variability in reporting, including (1) differences in product, (2) infusion rate, (3) dose and frequency of dosing, (4) patient population, and (5) relative experience of patient and physician. Both patients and physicians become steeled to the adverse events, and because incidents are not life threatening and often respond to prophylaxis medication, they are ignored as “normal.” Nonetheless, these events are common and affect health and quality of life of patients.

Infectious Disease Transfer

 A few early preparations of IVIg transmitted hepatitis C virus. Manufacturers have added viral inactivation and partitioning steps, and current licensed products are safe with respect to HIV, hepatitis C virus, hepatitis B virus, and other blood-borne pathogens. The industry has responded to the threat of prions with process validation, donor screening, donor testing, inventory management (look back), and plasma pool testing.

High-Dose Treatment–Related Adverse Events

 IVIg treatment for immune modulation of neurologic diseases requires doses of 1 to 2 g/kg body weight or two to five times the dose recommended for replacement therapy . Adverse events with high-dose administration include those listed in Table1 and occasionally thromboembolic events, renal complications, and anemia. Thromboembolic events include deep venous thrombosis, pulmonary embolism, myocardial infarction, and stroke. Thromboembolic events and renal failure seem to be independent of infusion rate. The cause of thromboembolic events is not known. Dalakas has suggested that increased serum viscosity plays a role. Factor XIa has also been identified in IVIg preparations. Factor XIa could directly lead to shortening of coagulation time and risk of thrombosis. Renal complications are rare but result in high morbidity and mortality.

Whether IgG, contaminants, or excipients are responsible is not clear. Of the 88 renal adverse events reported to the FDA, 90% were associated with products stabilized with sucrose. Whether the adverse events observed with IVIg treatment of neurologic diseases are related to a preexisting medical condition or the high doses required for treatment is not clear. Individuals deficient in IgA, such as those with common variable immune deficiency (CVID), can develop an ana phylactic reaction to IVIg, and products with low levels of IgA are recommended for such patients. Hemolysis can result in recipients who are not of blood type O, due to passive transfer of antibodies against A or B antigens. IVIg administration can also produce false-positive serologic tests for prior infections.

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مواضيع ذات صلة

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Immunoglobulins

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Focusing Antigen on Follicular Dendritic Cells

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