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Sleasman JW, Duff CM, Dunaway T, et al. Tolerability of a new 10% liquid immunoglobulin for intravenous use, Privigen, at different infusion rates. J Clin Immunol. 2010;30(3):442-8doi: 10.1007/s10875-010-9373-x.
Sleasman, J. W., Duff, C. M., Dunaway, T., Rojavin, M. A., & Stein, M. R. (2010). Tolerability of a new 10% liquid immunoglobulin for intravenous use, Privigen, at different infusion rates. Journal of clinical immunology, 30(3), 442-8. https://doi.org/10.1007/s10875-010-9373-x
Sleasman, John W, et al. "Tolerability of a new 10% liquid immunoglobulin for intravenous use, Privigen, at different infusion rates." Journal of clinical immunology vol. 30,3 (2010): 442-8. doi: https://doi.org/10.1007/s10875-010-9373-x
Sleasman JW, Duff CM, Dunaway T, Rojavin MA, Stein MR. Tolerability of a new 10% liquid immunoglobulin for intravenous use, Privigen, at different infusion rates. J Clin Immunol. 2010 May;30(3):442-8. doi: 10.1007/s10875-010-9373-x. Epub 2010 Mar 10. PMID: 20217199.
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J Clin Immunol. 2010 May;30(3):442-8. doi: 10.1007/s10875-010-9373-x. Epub 2010 Mar 10.

Tolerability of a new 10% liquid immunoglobulin for intravenous use, Privigen, at different infusion rates.

Journal of clinical immunology

John W Sleasman, Carla M Duff, Theresa Dunaway, Mikhail A Rojavin, Mark R Stein

Affiliations

  1. Department of Pediatrics, University of South Florida, St. Petersburg, FL, USA. [email protected]

PMID: 20217199 DOI: 10.1007/s10875-010-9373-x

Abstract

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.

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