Surveillance study on the tolerability and safety of Flebogamma^®DIF (10% and 5% intravenous immunoglobulin) in adult and pediatric patients

Abstract

Direct comparisons of tolerability and safety of concentrated intravenous immunoglobulin (IVIG) versus less concentrated products are scarce. In this postauthorization, prospective, observational, multicenter study, a systematic comparison of 10% and 5% concentrations of Flebogamma® DIF IVIG was performed in both adult and pediatric patients treated with the studied IVIG products according to the approved indications under routine conditions. Dose of product administered, adverse events (AEs), physical assessments, laboratory tests, and concomitant therapy were analyzed. Patient recruitment in the 10% and 5% product groups was, respectively, 34 (32 analyzed, 13 of them children, receiving 130 IVIG infusions) and 35 (34 analyzed, receiving 135 IVIG infusions). Twenty‐four infusions (18.5%; 95% CI: 11.8, 25.1) with the 10% product and 3 (2.2%; 95% CI: −0.3, 4.7) with the 5% product were associated with potentially treatment‐related AEs (P < 0.0001). Nine patients (28.1%) infused with the 10% product and 3 (8.8%) infused with the 5% product presented, respectively, 33 and 8 treatment‐related AEs (of which 7 and 6, respectively, were serious AEs, experienced by only three hypersensitive patients). The profile of AEs occurring with the infusion of 10% and 5% products were comparable. The most frequent treatment‐related AEs were headache (n = 17, 3 patients; 15 episodes, 1 patient) and pyrexia (n = 6, 4 patients). In conclusion, no unpredictable risk was detected for both Flebogamma DIF 10% and 5% concentrations, which were therefore deemed as safe and well‐tolerated IVIG in the studied population. The frequency of infusions associated with treatment‐related AEs was lower with the 5% concentration.

A randomized, controlled clinical trial of plasma exchange with albumin replacement for Alzheimer's disease: Primary results of the AMBAR Study

“…The percentage of dropouts (28%) over a period of 14 months (55 weeks) was similar to that reported elsewhere (13.5% to 31.3%), 7‐10,12 but was higher in the two IVIG arms (34.6%‐34.9%) and lower in the other arm and placebo, both without IVIG (20.0%‐21.8%), which is consistent with the safety profile reported in patients receiving infusions of albumin and IVIG 43,44 . In addition, only two (0.6%) patients died during the study, which is similar to the low mortality rates reported elsewhere (1.3%‐2.5%) 8‐10,12 .…”

Safety and Efficacy of Intravenous Immunoglobulin (Flebogamma ® 10% DIF) in Patients with Immune Thrombocytopenic Purpura

“…However, serious headaches requiring hospitalization are uncommon [11]. Overall, the surveillance study reported that the products were safe and well tolerated [10]. In the present study, no new safety concerns were identified, and the safety profile remained consistent with the known adverse effects of IVIG treatment.…”

“…These included an episode of severe headache in two patients which were considered to be possibly related to the study drug, as expected for IVIG treatment. A surveillance study on the tolerability and safety of Flebogamma R DIF (10 and 5% IVIG) in adult and pediatric patients found that the most frequent treatment-related AEs were headache and pyrexia [10]. However, serious headaches requiring hospitalization are uncommon [11].…”

Currently available intravenous immunoglobulin (Gamunex®-C and Flebogamma®DIF) contains antibodies reacting against SARS-CoV-2 antigens

“…It should be noted that IVIG products are generally deemed safe and welltolerated. Most of their adverse effects are mild and transient [25].…”