What is Octagam?
Octagam is a 5% intravenous immunoglobulin (IVIG) solution made from human plasma. It contains purified immunoglobulin G (IgG) antibodies pooled from thousands of healthy donors to treat primary immunodeficiency diseases and other conditions requiring immune support.[1]
Main Active Component
The primary active ingredient is human normal immunoglobulin G (IgG), at a concentration of 50 mg/mL (5% solution). IgG makes up over 95% of the total immunoglobulins, with a typical distribution of:
- IgG1: ~60%
- IgG2: ~32%
- IgG3: ~7%
- IgG4: ~1%
This mirrors the IgG subclass ratios in normal human plasma.[1][2]
Stabilizers and Excipients
Octagam includes:
- Maltose (10%, or 100 mg/mL) as the main stabilizer.
- Sodium chloride (0.9%, or 9 mg/mL) for isotonicity.
- No preservatives; it's sterile-filtered.
The formulation avoids sugars like sucrose or glycine, reducing risks like renal issues in some patients.[1]
How Octagam is Produced
Plasma is sourced from screened U.S. donors, cold-ethanol fractionated (Cohn-Oncley process), treated with solvent-detergent for viral inactivation, and nanofiltered (35 nm pores) for additional pathogen removal. Final IgG purity exceeds 98%.[1][2]
Differences from Other IVIGs
Compared to competitors like Gammagard (glycine-stabilized) or Privigen (sucrose-stabilized), Octagam's maltose stabilizer may lower osmotic nephrosis risk. All share similar IgG profiles but vary in manufacturing and additives.[2]
Common Patient Questions on Components
Patients often ask if Octagam contains latex (no), albumin (trace amounts only), or IgA (minimal, <50 mcg/mL, safe for most IgA-deficient patients). Trace proteins like IgM and IgA are below 5 mg/mL.[1]
[1]: Octagam Prescribing Information (FDA)
[2]: DrugPatentWatch.com - Octagam