Preserving Immunoglobulin Integrity

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Octagam 5% is manufactured using well-controlled processing steps designed to be gentle and to preserve the structural and functional integrity of its immunoglobulin G (IgG)1

Octagam 5% Manufacturing Image

Formulated to help mitigate tolerability issues in patients with PI1-4

Parameter Details
Maltose [mg/mL] – (no preservatives or sucrose) 100 (=2 mg per mg IgG)
Sodium [mmol/L] ≤30
pH 5.1-6.0
Osmolality [mosmol/kg] 310-380

Download the maltose fact sheet.

In a 12-month, open-label, pivotal trial in patient with PI

Tolerability Assessed
Over 12 Months

In Both Pediatric and Adult Patients*
 Most Common
Adverse Reactions During Clinical Trial†

Headache (15% of subjects) and Nausea (7% of subjects)

*n=46; (11 patients were <16 years of age); a total of 654 total infusions were administered. †Drug-related ARs during infusion or within 72 hours of infusion in over 5% of patients.

Biochemical profile closely resembles native IgG1,2,5-7

  • Contains all 4 subclasses of IgG, with a percentage distribution equivalent to the one found in normal plasma
  • Physiologic Fc function of IgG is maintained intact

Review the manufacturing and purification process for octagam 5% here.

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References:
  1. Octapharma. Data on file.
  2. Octagam 5% Full Prescribing Information. Paramus, NJ: Octapharma; rev April 2022.
  3. 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.
  4. Stein MR. The new generation of liquid intravenous immunoglobulin formulations in patient care: a comparison of intravenous immunoglobulins. Postgrad Med. 2010;122(5):176-84.
  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.