PMID- 20217199
OWN - NLM
STAT- MEDLINE
DCOM- 20100922
LR  - 20181113
IS  - 1573-2592 (Electronic)
IS  - 0271-9142 (Linking)
VI  - 30
IP  - 3
DP  - 2010 May
TI  - Tolerability of a new 10% liquid immunoglobulin for intravenous use, Privigen, at 
      different infusion rates.
PG  - 442-8
LID - 10.1007/s10875-010-9373-x [doi]
AB  - 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.
FAU - Sleasman, John W
AU  - Sleasman JW
AD  - Department of Pediatrics, University of South Florida, St. Petersburg, FL, USA. 
      jsleasma@health.usf.edu
FAU - Duff, Carla M
AU  - Duff CM
FAU - Dunaway, Theresa
AU  - Dunaway T
FAU - Rojavin, Mikhail A
AU  - Rojavin MA
FAU - Stein, Mark R
AU  - Stein MR
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20100310
PL  - Netherlands
TA  - J Clin Immunol
JT  - Journal of clinical immunology
JID - 8102137
RN  - 0 (Immunoglobulins, Intravenous)
RN  - 0 (Immunologic Factors)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Agammaglobulinemia/*drug therapy/immunology
MH  - Aged
MH  - Child
MH  - Child, Preschool
MH  - Common Variable Immunodeficiency/*drug therapy/immunology
MH  - *Drug Dosage Calculations
MH  - Female
MH  - Humans
MH  - Immunoglobulins, Intravenous/administration & dosage/*adverse effects
MH  - Immunologic Factors/administration & dosage/*adverse effects
MH  - Infusion Pumps
MH  - Male
MH  - Middle Aged
EDAT- 2010/03/11 06:00
MHDA- 2010/09/24 06:00
CRDT- 2010/03/11 06:00
PHST- 2009/12/22 00:00 [received]
PHST- 2010/01/26 00:00 [accepted]
PHST- 2010/03/11 06:00 [entrez]
PHST- 2010/03/11 06:00 [pubmed]
PHST- 2010/09/24 06:00 [medline]
AID - 10.1007/s10875-010-9373-x [doi]
PST - ppublish
SO  - J Clin Immunol. 2010 May;30(3):442-8. doi: 10.1007/s10875-010-9373-x. Epub 2010 
      Mar 10.