Why octagam 10% Therapy for Adults with Dermatomyositis?

Octagam 10% Is the First and Only IVIg FDA Approved for the Treatment of Dermatomyositis in Adults

Ready-to-Use, Liquid Preparation of Highly Purified Human IVIg1,2

  • Made from large pools of donated plasma which go through a rigorous purification process for the inactivation and removal of viruses
  • Manufactured by cold ethanol fractionation process followed by ultrafiltration and chromatography
  • Manufacturing process includes treatment with an organic Solvent/Detergent (S/D) mixture
  • Viral reduction is achieved through a combination of process steps including cold ethanol fractionation, S/D treatment and pH 4 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.

Octagam 10% Does Not Contain Sucrose or Other Preservatives

FractionationCold ethanol, ultrafiltration, chromatography
Total protein (mg/mL)~100 (≥96% IgG)
IgA (μg/mL)106 (average)
Maltose (mg/mL)90
Sodium (mmol/L)≤30
pH4.5 – 5.0
Osmolality (mOsmol/kg)310 to 380

Biochemical Profile That Resembles Native IgG2

  • All 4 IgG subclasses are fully represented
  • Physiologic Fc function of IgG is maintained intact

Fc=fragment crystallizable.

Native IgG3

Review the manufacturing and purification process for octagam 10%.

References:
  1. Octapharma. Data on File.
  2. Octagam 10% Full Prescribing Information. Paramus, NJ: Octapharma USA Inc; rev June 2021.