![]() Dosing for therapeutic polyclonal intravenous immunoglobulin (IVIG) products is considered to be patient specific, with an increase in dose associated with decreased incidence of infection and improved outcomes. Although the FDA defines minimum antibody concentration for these pathogens, standards for antibodies against other common pathogens are not defined, resulting in significant variation among the different commercial IG products in antibody titers to important pathogens. These requirements include standards for concentration of antibodies to diphtheria toxoid (≥1.21 U/ml), measles (≥0.60 CBER reference) and polio (≥0.28 CBER reference). In the USA, there are multiple IG products currently approved that meet the minimum standards for concentration of antibodies set by the US FDA guidance 21 CFR 640 subpart J. Within this population, regular infusions with IG prevents most of the serious bacterial infections but often fails to provide sufficient antibody supplementation against viral pathogens to which these patients are susceptible. Supplementation with immunoglobulins (IG) is considered to be the standard of care for the treatment of patients with humoral deficiencies that reflect B and T cell abnormalities. ![]() Primary immunodeficiency diseases (PIDDs) are a collection of disorders that result in deficient antibody production due to abnormalities of multiple cell lineages in the adaptive and innate immune response.
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