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Kedrion SCIg is a 16% subcutaneous human normal immunoglobulin (SCIg) preparation developed by Kedrion Biopharma for the treatment of primary and secondary immunodeficiency disorders. As a plasma-derived biologic, it consists of highly purified immunoglobulin G (IgG) antibodies harvested from human plasma pools. The therapy is designed to provide passive immunity by replacing deficient or absent endogenous IgG, thereby preventing recurrent bacterial and viral infections in patients with hypogammaglobulinaemia or agammaglobulinaemia. The 16% concentration allows for the administration of high doses in smaller volumes compared to lower-concentration formulations, facilitating subcutaneous delivery. It has been evaluated in Phase II/III clinical trials in Italy, demonstrating efficacy, safety, and tolerability as a replacement therapy.
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