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Erschienen in:
01.05.2010
Tolerability of a New 10% Liquid Immunoglobulin for Intravenous Use, Privigen®, at Different Infusion Rates
Erschienen in: Journal of Clinical Immunology | Ausgabe 3/2010
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Purpose
The tolerability of L-proline-stabilized Privigen®, a new 10% liquid immunoglobulin for intravenous administration, was assessed at high infusion rates in a Phase III, open-label, single-arm, multicenter study in 45 patients with primary immune deficiencies.
Patients and Methods
Maximum infusion rates were not assigned prospectively. For analysis, patients were grouped according to maximum infusion rate in a low infusion rate group (8 mg/kg/min) and high infusion rate group (12 mg/kg/min).
Results
Twenty-three patients, selected at the investigators’ discretion for the high infusion rate group based on their good tolerability, tolerated Privigen® at 12 mg/kg/min with no increase in temporally associated adverse events (AEs) above the level they had experienced at 8 mg/kg/min. The proportion of infusions with temporally associated AEs in these patients was 0.079 [97.5% confidence interval (CI) 0.114] compared to 0.211 (97.5% CI 0.267) in the low infusion rate group. The most frequent AE was headache. Thus, selected patients tolerate Privigen® at high infusion rates.