Almost Three Decades of Post-Marketing Experience With A Human Intravenous Immunoglobulin 5%: Analysis of A Propriety Pharmacovigilance Database

Intravenous immunoglobulin (IVIg) therapies are widely used for replacement and immunomodulatory indications but are associated with known risks of adverse drug reactions (ADRs), underscoring the importance of long-term, product-specific safety surveillance. This analysis evaluated long-term real-world safety profile of a 5% IVIg product approved for replacement therapy in primary and secondary immunodeficiencies and for immunomodulatory indications. Spontaneous post-marketing ADR reports for Kedrion 5% IVIg (January 1997–May 2025) were descriptively analyzed using the Kedrion Pharmacovigilance Database. ADRs were defined per regulatory criteria and summarized by frequency, seriousness, demographics, and estimated IVIg exposure. An estimated 3,391,766 doses were distributed worldwide, with 2,500 ADRs reported in 958 individual cases, corresponding to an overall individual case reporting rate of 2.8 per 10,000 infusions. The most frequently reported ADRs were headache, pyrexia, vomiting, chills, nausea, and urticaria, with reporting rates ranging from 0.44 to 0.16 per 10,000 infusions. ADRs were predominantly non-serious. Individuals aged 40–64 years accounted for the highest proportion of reported and serious ADRs, followed by those aged 18–39 years and 65–74 years; distribution by sex generally mirrored age-group patterns. Annual reporting varied over time, with higher numbers of reports in recent years, while the overall nature of reported ADRs remained consistent. This analysis represents one of the largest and longest post-marketing pharmacovigilance evaluations of an individual IVIg product. Findings demonstrate stable long-term safety and an ADR profile consistent with clinical trial data and approved product labeling, supporting a favorable benefit–risk profile.