What is octagam 10%?
Octagam 10% is indicated for treatment of chronic immune thrombocytopenic purpura (ITP) in adults
Octagam 10% 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 adults with chronic ITP1,3,4
- Validated removal and inactivation of viruses3,5,6
- Provides lasting protection for patients with PI3,4
- A biochemical profile that resembles native IgG3
- Convenient, ready-to-use, easy-to-store, liquid formulation1,3
Octagam 10% is made from large pools of donated plasma which go through a rigorous purification process for the inactivation and removal of viruses1,3
- 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 Octoxynol
- Viral reduction is achieved through a combination of process steps including cold ethanol fractionation, S/D treatment and pH4 treatment
- Other precautions against viral transmission include: selection of plasma donors, screening of donations and plasma pool, as well as final product testing for viruses
Octapharma’s global immunotherapy portfolio offers high-purity human IgG products available in different concentrations and routes of administration in liquid, ready-to-use formulations.
*Includes congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome and severe combined immunodeficiencies
- Octapharma, Data on File. 2014.
- 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 10% Full Prescribing Information. Hoboken, NJ: Octapharma USA Inc; rev May 2018.
- Robak T, Mainau C, Pyringer B, et al. Efficacy and safety of a new intravenous immunoglobulin 10% formulation (Octagam 10%) in patients with immune thrombocytopenia. Hematology. 2010;15(5):351-359.
- Dichtelmüller HO, Biesert L, Fabbrizzi F, et al. Contribution to safety of immunoglobulin and albumin from virus partitioning and inactivation by cold ethanol fractionation: a data collection of Plasma Protein Therapeutics Association member companies. Transfusion. 2011;51(7):1412- 1430.
- Dichtelmüller HO, BiesertL, FabbrizziF, et al. Robustness of solvent/detergent treatment of plasma derivatives: a data collection of Plasma Protein Therapeutics Association member companies. Transfusion. 2009;49(9):1931-1943.