PMID- 28971614
OWN - NLM
STAT- MEDLINE
DCOM- 20180523
LR  - 20210109
IS  - 2052-1707 (Electronic)
IS  - 2052-1707 (Linking)
VI  - 5
IP  - 5
DP  - 2017 Oct
TI  - Surveillance study on the tolerability and safety of Flebogamma((R)) DIF (10% and 
      5% intravenous immunoglobulin) in adult and pediatric patients.
LID - 10.1002/prp2.345 [doi]
LID - e00345
AB  - 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(R) 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.
CI  - (c) 2017 The Authors. Pharmacology Research & Perspectives published by John Wiley 
      & Sons Ltd, British Pharmacological Society and American Society for Pharmacology 
      and Experimental Therapeutics.
FAU - Alsina, Laia
AU  - Alsina L
AD  - Allergy and Clinical Immunology Department, Hospital Sant Joan de Deu, Institut 
      de Recerca Pediatrica Hospital Sant Joan de Deu, Passeig de Sant, Joan de Deu 2, 
      08950, Esplugues de Llobregat, Barcelona, Spain.
FAU - Mohr, Andreas
AU  - Mohr A
AD  - Hematology and Oncology, OncoResearch Lerchenfeld, Lerchenfeld 14, 22081, 
      Hamburg, Germany.
FAU - Montanes, Maria
AU  - Montanes M
AD  - Pharmacovigilance Department, Instituto Grifols S.A., Avinguda de la Generalitat 
      152-158, 08174, Sant Cugat del Valles, Barcelona, Spain.
FAU - Oliver, Xenia
AU  - Oliver X
AD  - Pharmacovigilance Department, Instituto Grifols S.A., Avinguda de la Generalitat 
      152-158, 08174, Sant Cugat del Valles, Barcelona, Spain.
FAU - Martin, Esperanza
AU  - Martin E
AD  - Pneumology Service, Hospital Sant Joan de Deu, Fundacio Althaia. Carrer Dr. Joan 
      Soler, s/n, 08243, Manresa, Spain.
FAU - Pons, Jaime
AU  - Pons J
AD  - Immunology Service, Hospital Son Espases, Carrer de Valldemossa 79, 07120, Palma 
      de Mallorca, Spain.
FAU - Drewe, Elizabeth
AU  - Drewe E
AD  - Clinical Immunology and Allergy Department, Nottingham University Hospitals - QMC 
      Campus, Hucknall Road, Nottingham, NG5 1PB, UK.
FAU - Papke, Jens
AU  - Papke J
AD  - Practice and Day Clinic for Internal Medicine and Oncology, Rosa-Luxemburg-Strasse 
      6, 01844, Neustadt in Sachsen, Germany.
FAU - Gunther, Georg
AU  - Gunther G
AD  - Medical Healthcare Centre for Blood and Cancer Diseases, Kurfurstenstrasse 20, 
      D-14467, Potsdam, Germany.
FAU - Chee, Ronnie
AU  - Chee R
AD  - Clinical Immunology Department, Royal Free London NHS Foundation Trust, 17 
      Lyndhurst Gardens, London, NW3 5NU, UK.
FAU - Gompels, Mark
AU  - Gompels M
AD  - Immunology and Allergy Department, Southmead Hospital, Dorian Way, 
      Westbury-on-Trym, Bristol, BS10 5NB, UK.
CN  - investigators of the Flebogamma DIF PASS Study Group
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Pharmacol Res Perspect
JT  - Pharmacology research & perspectives
JID - 101626369
RN  - 0 (Immunoglobulins, Intravenous)
SB  - IM
MH  - Aged
MH  - Child
MH  - Child, Preschool
MH  - Dose-Response Relationship, Drug
MH  - Female
MH  - Headache/chemically induced/*epidemiology
MH  - Humans
MH  - Immunoglobulins, Intravenous/administration & dosage/*adverse effects
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
PMC - PMC5625155
OTO - NOTNLM
OT  - Adverse events
OT  - Flebogamma DIF
OT  - immunoglobulin therapy
OT  - infusions
OT  - physician practice
OT  - safety
EDAT- 2017/10/04 06:00
MHDA- 2018/05/24 06:00
PMCR- 2017/08/25
CRDT- 2017/10/04 06:00
PHST- 2017/07/18 00:00 [received]
PHST- 2017/07/20 00:00 [accepted]
PHST- 2017/10/04 06:00 [entrez]
PHST- 2017/10/04 06:00 [pubmed]
PHST- 2018/05/24 06:00 [medline]
PHST- 2017/08/25 00:00 [pmc-release]
AID - PRP2345 [pii]
AID - 10.1002/prp2.345 [doi]
PST - ppublish
SO  - Pharmacol Res Perspect. 2017 Oct;5(5):e00345. doi: 10.1002/prp2.345.