Which intravenous immunoglobulin (IVIG) preparations are marketed in the US?

Updated: Jul 05, 2018
  • Author: Jessica Katz, MD, PhD, FACP; Chief Editor: Emmanuel C Besa, MD  more...
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Answer

Answer

The following IVIG preparations are marketed in the United States:

  • Gammagard S/D (Baxter/Hyland; Deerfield, Ill)

    • Lyophilized powder in 5% and 10% concentrations

    • Sodium content in mEq/mL of 0.85%

    • Contains IgM in trace amounts

    • Manufactured by the Cohn-Oncley cold ethanol fractionation process followed by ultrafiltration and ion exchange chromatography; solvent detergent treated; prepared from "a large number of donors"

    • Additives in 5% solution include 0.3% albumin, 2.25% glycine, and 2% glucose

    • pH of 6.8

    • IgA content of 1.6 mcg/mL in 5% solution

  • Gammar-IV (Armour; Blue Bell, Pa)

    • Lyophilized powder in 5% concentration

    • Sodium content in mEq/mL of 0.5%

    • Prepared by cold alcohol fractionation of pooled plasma; not chemically altered or enzymatically degraded; prepared from a large pool of at least 1000 donors

    • IgA content of less than 25 mcg/mL

  • Gamimune-N (Miles; Elkhart, Ind; Bayer)

    • Sterile solution in 5% and 10% concentrations

    • Sodium content in mEq/mL considered trace amount (incompatible in saline)

    • Not sugar-glycine based

    • Advanced viral removal and inactivation technologies used in manufacturing; solvent detergent treated

    • Contraindicated in patients with history of prior systemic allergic reaction to IVIG products or a history of IgA deficiency

    • pH of 4-4.5

    • Additives in 5% solution include 9-11% maltose; in 10% solution, 0.16-0.24 M glycine

    • IgA content of 270 mcg/mL

  • Iveegam (Immuno-US; Rochester, NY)

    • Lyophilized power in 5% concentration

    • Sodium content in mEq/mL of 0.3%

    • Prepared using modified Cohn-fractionation process combined with hydrolase treatment and polyethylene glycol precipitation

    • Additives in 5% solution include 5% glucose and 0.3% NaCl

    • pH of 7.0

    • IgA content of less than 10 mcg/mL

  • Polygam S/D (Baxter/Hyland for American Red Cross; Washington, DC)

    • Lyophilized powder in 5% and 10% concentrations

    • Sodium content in mEq/mL of 0.85%

    • Manufactured by the Cohn-Oncley cold ethanol fractionation process followed by ultrafiltration and ion exchange chromatography; solvent detergent treated; sterile, freeze-dried preparation of highly purified IgG derived from large pools of human plasma

    • Additives in 5% concentration include 0.3% albumin, 2.25% glycine, and 2% glucose

    • pH of 6.8

    • IgA content less than 1.2 mcg/mL

  • Sandoglobulin (Sandoz; Vienna, Austria)

    • Lyophilized powder in 3%, 6%, 9%, and 12% concentrations

    • Sterile, highly purified polyvalent antibody product that contains, in concentrated form, all IgG antibodies regularly occurring in donor population

    • Produced by cold alcohol fractionation from the plasma of volunteer US donors; fractionation process includes several filtration steps performed in presence of filter aids; some filtration steps used for separation of cold ethanol precipitate

    • Additives per gram of IgG include 1.67 g sucrose and less than 20 mg NaCl

    • pH of 6.6

    • IgA content of 720 mcg/mL

  • Venoglobulin-I or Venoglobulin-S (Alpha Therapeutic; Los Angeles, Calif)

    • Sterile solution in 5% and 10% concentrations

    • Sodium content in mEq/mL is less than 1

    • Prepared using cold alcohol fraction, polyethylene glycol bentonite fraction, and ion exchange chromatography; solvent detergent treated

    • Additives in 5% solution include 5% sorbitol and 0.13% albumin; in 10% solution, 5% sorbitol and 0.26% albumin

    • pH of 5.2-5.8

    • IgA content of 15-50 mcg/mL

  • Carimune/Panglobulin (ZLB Bioplasma/ARC Swiss Red Cross)

    • Lyophilized powder in 3%, 6%, 9%, and 12% concentrations

    • Sodium content in mEq/mL 0-0.9% depending on preparation

    • Viral inactivation and preparation involves Kistler-Nitschmann; cold alcohol fractionation using pH of 4.0, trace pepsin, and nanofiltration

    • pH of Panglobulin is 6.6

    • IgA content of 720 mcg/mL

  • Gamunex (Bayer)

    • Sterile solution

    • Sodium content in mEq considered trace amount (incompatible in saline)

    • Not sugar-glycine based

    • Viral inactivation and preparation uses pH 4.25, caprylate, ion exchange chromatography, and low salt

    • IgA content of 46 mcg/mL


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