What Is octagam 5%?
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.
- Octapharma. Data on file.
- 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.
- Octagam 5% Full Prescribing Information. Paramus, NJ: Octapharma; rev April 2022.
- 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.
- 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.
- 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.
- French MAH, Harrison G. Serum IgG subclass concentrations in healthy adults: a study using monoclonal antisera. Clin Exp Immunol. 1984;56:473-475.