Safety of L-proline as a stabilizer for immunoglobulin products

John B. Hagan, Richard L. Wasserman, Jeffrey S. Baggish, Martin O. Spycher, Melvin Berger, Vandana Shashi, Emanuel Lohrmann, Kathleen E. Sullivan

Research output: Contribution to journalReview article

7 Scopus citations

Abstract

Privigen ® (immune globulin intravenous [human], 10% liquid) and Hizentra ® (immune globulin subcutaneous [human], 20% liquid) are stabilized by proline. The clinical implications of administering proline-containing immunoglobulin products to patients with defects of proline metabolism have not been addressed; Privigen and Hizentra are contraindicated in these patients. Some patients with chromosome 22q11.2 deletion syndrome have elevated proline levels; however, only 3-4% of patients also have an immunodeficiency that requires IgG therapy. This review summarizes the evidence related to the safety and pharmacokinetics of proline assessed in Privigen and Hizentra preclinical and clinical studies, and subsequent implications for patients with defects in proline metabolism. Clinical data indicate that proline does not accumulate after Privigen or Hizentra treatment and is not associated with adverse events. There is no evidence to suggest that patients with defects of proline metabolism would be affected by transient elevations in plasma proline following Privigen and/or Hizentra treatment.

Original languageEnglish (US)
Pages (from-to)169-178
Number of pages10
JournalExpert Review of Clinical Immunology
Volume8
Issue number2
DOIs
StatePublished - Feb 1 2012

Keywords

  • 22q11.2 deletion syndrome
  • hyperprolinemia
  • intravenous immunoglobulin
  • pharmacokinetics
  • proline
  • proline metabolism
  • safety
  • subcutaneous immunoglobulin

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology

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  • Cite this

    Hagan, J. B., Wasserman, R. L., Baggish, J. S., Spycher, M. O., Berger, M., Shashi, V., Lohrmann, E., & Sullivan, K. E. (2012). Safety of L-proline as a stabilizer for immunoglobulin products. Expert Review of Clinical Immunology, 8(2), 169-178. https://doi.org/10.1586/eci.11.97