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

Autor: Alsina, Laia, Mohr, Andreas, Montañés, Maria, Oliver, Xènia, Martín, Esperanza, Pons, Jaime, Drewe, Elizabeth, Papke, Jens, Günther, Georg, Chee, Ronnie, Gompels, Mark
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Zdroj: Pharmacology Research & Perspectives; Oct2017, Vol. 5 Issue 5, pn/a-N.PAG, 11p
Abstrakt: 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. [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index
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