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Efficacy, Pharmacokinetics, Safety, and Tolerability of Flebogamma® 10% DIF, a High-Purity Human Intravenous Immunoglobulin, in Primary Immunodeficiency

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Abstract

Background

Flebogamma® 10% DIF represents an evolution of intravenous immune globulin from the previous 5% product to be administered at higher rates and with smaller infusion volumes. Pathogen safety is enhanced by the combination of multiple methods with different mechanisms of action.

Objective

The objective of this study as to evaluate the efficacy, pharmacokinetics, and safety of Flebogamma® 10% DIF for immunoglobulin replacement therapy in primary immunodeficiency diseases (PIDD).

Methods

Flebogamma® 10% DIF was administered to 46 subjects with well-defined PIDD at a dose of 300–600 mg/kg every 21–28 days for 12 months.

Results

Serious bacterial infection rate was 0.025/subject/year. Half-life in serum of the administered IgG was approximately 35 days. No serious treatment-related adverse event (AE) occurred in any patient. Most of the potentially treatment-related AEs occurred during the infusion, accounting for 20% of the 601 infusions administered.

Conclusions

Flebogamma® 10% DIF is efficacious and safe, has adequate pharmacokinetic properties, and is well-tolerated for the treatment of PIDD.

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Author information

Authors and Affiliations

  1. Case Western Reserve University, Cleveland, OH, USA

    Melvin Berger

  2. Grifols Biologicals Inc., Millersville, MD, USA

    Paul J. Pinciaro

  3. Kentuckiana Asthma and Allergy Center, Louisville, KY, USA

    Arthur Althaus

  4. Women and Children’s Hospital of Buffalo, Division of Allergy & Immunology, Department of Pediatrics, SUNY Buffalo, 219 Bryant Street, Buffalo, NY, 14222, USA

    Mark Ballow

  5. Rainbow Babies and Children’s Hospital, Cleveland, OH, USA

    Akhilesh Chouksey

  6. Rush Presbyterian St. Luke’s Medical Center, Chicago, IL, USA

    James Moy

  7. University of Washington, Seattle, WA, USA

    Hans Ochs

  8. Allergy Associates of the Palm Beaches, North Palm Beach, FL, USA

    Mark Stein

Authors
  1. Melvin Berger
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  2. Paul J. Pinciaro
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  3. Arthur Althaus
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  4. Mark Ballow
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  5. Akhilesh Chouksey
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  6. James Moy
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  7. Hans Ochs
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  8. Mark Stein
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Corresponding author

Correspondence to Mark Ballow.

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Berger, M., Pinciaro, P.J., Althaus, A. et al. Efficacy, Pharmacokinetics, Safety, and Tolerability of Flebogamma® 10% DIF, a High-Purity Human Intravenous Immunoglobulin, in Primary Immunodeficiency. J Clin Immunol 30, 321–329 (2010). https://doi.org/10.1007/s10875-009-9348-y

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  • DOI: https://doi.org/10.1007/s10875-009-9348-y

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