What Is octagam 5%?

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Octagam 5% is indicated for treatment of both pediatric and adult patients with primary humoral immunodeficiency (PI)*

 

Octagam 5% is manufactured to preserve immunoglobulin integrity

  • Processing steps designed to preserve the structural and functional integrity of IgG1,2
  • Formulated to help mitigate tolerability issues in patient with PI1,3
  • Validated removal and inactivation of viruses1,3
  • Provides lasting protection for patients with PI3,4
  • A biochemical profile that resembles native IgG1,3,5-7
  • Convenient, ready-to-use, easy-to-store, liquid formulation3

Octagam 5% is made from large pools of donated plasma which go through a rigorous purification process for the inactivation and removal of viruses1

  • Manufactured by cold ethanol fractionation process followed by ultrafiltration and chromatography
  • Manufacturing process includes treatment with an organic solvent/detergent (S/D) mixture composed of tri-n-butyl phosphate (TNBP) and Octoxynol1
  • Viral reduction is achieved through a combination of process steps including cold ethanol fractionation, S/D treatment and pH4 treatment1
  • Other precautions against viral transmission include: selection of plasma donors, screening of donations and plasma pool, as well as final product testing for viruses1

*Includes congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome and severe combined immunodeficiencies.

To learn how octagam 5% preserves the structural and functional integrity of its immunoglobulin

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References:
  1. Octapharma. Data on file.
  2. Buchacher A, Kaar W. Intravenous immunoglobin G from human plasma—purification concepts and important quality criteria. In: Bertolini J, Goss N, Curling J, eds. Production of Plasma Proteins for Therapeutic Use. Hoboken, NJ: John Wiley & Sons, Inc; 2013.
  3. Octagam 5% Full Prescribing Information. Paramus, NJ: Octapharma; rev April 2022.
  4. Ochs HD, Pinciaro PJ; The octagam® Study Group. octagam® 5%, an intravenous IgG product, is efficacious and well tolerated in subjects with primary immunodeficiency diseases. J Clin Immunol. 2004;24(3):309-314.
  5. Yount WJ, Dorner MM, Kunkel HG, Kabat EA. Studies on human antibodies. IV. Selective variations in subgroup composition and genetic markers. J Exp Med. 1968;127:633-646.
  6. Shakib F, Stanworth DR, Drew R, Catty D. A quantitative study of the distribution of IgG sub-classes in a group of normal human sera. J Immunol Methods. 1975;8:17-28.
  7. French MAH, Harrison G. Serum IgG subclass concentrations in healthy adults: a study using monoclonal antisera. Clin Exp Immunol. 1984;56:473-475.