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


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.
Sleasman
John W
JW
Department of Pediatrics, University of South Florida, St. Petersburg, FL, USA. jsleasma@health.usf.edu
Duff
Carla M
CM
Dunaway
Theresa
T
Rojavin
Mikhail A
MA
Stein
Mark R
MR
D000293:Adolescent; D000328:Adult; D000361:Agammaglobulinemia / Q000188:drug therapy* / Q000276:immunology; D000368:Aged; D002648:Child; D002675:Child, Preschool; D017074:Common Variable Immunodeficiency / Q000188:drug therapy* / Q000276:immunology; D054796:Drug Dosage Calculations; D005260:Female; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000008:administration & dosage / Q000009:adverse effects*; D007155:Immunologic Factors / Q000008:administration & dosage / Q000009:adverse effects*; D007260:Infusion Pumps; D008297:Male; D008875:Middle Aged
D016756:Immunoglobulins, Intravenous; D007155:Immunologic Factors