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Flebogamma(®) 5 % DIF Intravenous Immunoglobulin for Replacement Therapy in Children with Primary Immunodeficiency Diseases.

Publication ,  Journal Article
Ballow, M; Pinciaro, PJ; Craig, T; Kleiner, G; Moy, J; Ochs, HD; Sleasman, J; Smits, W
Published in: J Clin Immunol
August 2016

PURPOSE: The previous studies with Flebogamma(®) 5 % DIF intravenous immunoglobulin (IVIG) contained insufficient numbers of pediatric subjects to fully warrant a pediatric indication by the FDA. The objective of this study was to evaluate the efficacy, safety, and pharmacokinetics of Flebogamma® 5 % DIF for replacement therapy in children (age 2-16) with primary immunodeficiency diseases (PIDD). METHODS: IVIG was administered at eight clinical sites to 24 subjects with well-defined PIDD at a dose of 300-800 mg/kg every 21-28 days for 12 months. The pharmacokinetics endpoint in this study was the dose-adjusted increment of the serum IgG trough levels. RESULTS: The calculated serious bacterial infection rate was 0.05/subject/year. The incidence of adverse events considered potentially related to IVIG during or within 72 h after completing an infusion was within the FDA guidance threshold of <40 % at each time point. Dose-adjusted incremental IgG levels remained approximately equal to or slightly greater than pre-study IgG levels (between 800 and 1000 mg/dL throughout) when the subjects were treated with IVIG therapy other than Flebogamma(®) DIF 5 % indicating no evidence of a different pharmacokinetic profile in this pediatric population if compared to those profiles in previous Flebogamma studies in predominately adult populations. CONCLUSIONS: Flebogamma(®) 5 % DIF is efficacious and safe, has adequate pharmacokinetic properties, is well-tolerated, and maintains the profile of Flebogamma(®) 5 % for the treatment of children with primary humoral immunodeficiency diseases.

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Published In

J Clin Immunol

DOI

EISSN

1573-2592

Publication Date

August 2016

Volume

36

Issue

6

Start / End Page

583 / 589

Location

Netherlands

Related Subject Headings

  • Treatment Outcome
  • Time Factors
  • Male
  • Immunology
  • Immunologic Deficiency Syndromes
  • Immunoglobulins, Intravenous
  • Humans
  • Female
  • Child, Preschool
  • Child
 

Citation

APA
Chicago
ICMJE
MLA
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Ballow, M., Pinciaro, P. J., Craig, T., Kleiner, G., Moy, J., Ochs, H. D., … Smits, W. (2016). Flebogamma(®) 5 % DIF Intravenous Immunoglobulin for Replacement Therapy in Children with Primary Immunodeficiency Diseases. J Clin Immunol, 36(6), 583–589. https://doi.org/10.1007/s10875-016-0303-4
Ballow, Mark, Paul J. Pinciaro, Timothy Craig, Gary Kleiner, James Moy, Hans D. Ochs, John Sleasman, and William Smits. “Flebogamma(®) 5 % DIF Intravenous Immunoglobulin for Replacement Therapy in Children with Primary Immunodeficiency Diseases.J Clin Immunol 36, no. 6 (August 2016): 583–89. https://doi.org/10.1007/s10875-016-0303-4.
Ballow M, Pinciaro PJ, Craig T, Kleiner G, Moy J, Ochs HD, et al. Flebogamma(®) 5 % DIF Intravenous Immunoglobulin for Replacement Therapy in Children with Primary Immunodeficiency Diseases. J Clin Immunol. 2016 Aug;36(6):583–9.
Ballow, Mark, et al. “Flebogamma(®) 5 % DIF Intravenous Immunoglobulin for Replacement Therapy in Children with Primary Immunodeficiency Diseases.J Clin Immunol, vol. 36, no. 6, Aug. 2016, pp. 583–89. Pubmed, doi:10.1007/s10875-016-0303-4.
Ballow M, Pinciaro PJ, Craig T, Kleiner G, Moy J, Ochs HD, Sleasman J, Smits W. Flebogamma(®) 5 % DIF Intravenous Immunoglobulin for Replacement Therapy in Children with Primary Immunodeficiency Diseases. J Clin Immunol. 2016 Aug;36(6):583–589.
Journal cover image

Published In

J Clin Immunol

DOI

EISSN

1573-2592

Publication Date

August 2016

Volume

36

Issue

6

Start / End Page

583 / 589

Location

Netherlands

Related Subject Headings

  • Treatment Outcome
  • Time Factors
  • Male
  • Immunology
  • Immunologic Deficiency Syndromes
  • Immunoglobulins, Intravenous
  • Humans
  • Female
  • Child, Preschool
  • Child