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

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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Xie F, Blackhouse G, Assasi N, et al. Results of a model analysis to estimate cost utility and value of information for intravenous immunoglobulin in Canadian adults with chronic immune thrombocytopenic purpura. Clin Ther. 2009 May. 31(5):1082-91; discussion 1066-8. [Medline].
Yamane Y, Aihara M, Tatewaki S, et al. [Analysis of treatments and deceased cases of severe adverse drug reactions--analysis of 46 cases of Stevens-Johnson syndrome and toxic epidermal necrolysis]. Arerugi. 2009 May. 58(5):537-47. [Medline].
Perez EE, Orange JS, Bonilla F, Chinen J, Chinn IK, Dorsey M, et al. Update on the use of immunoglobulin in human disease: A review of evidence. J Allergy Clin Immunol. 2017 Mar. 139 (3S):S1-S46. [Medline].
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Media Gallery

Schematic representation of an immunoglobulin G molecule. CH indicates constant region of heavy chain; CL, constant region of light chain; VH, variable region of heavy chain; and VL, variable region of light chain.

of 1

Author

Jessica Katz, MD, PhD, FACP Senior Medical Director, Immuno-Oncology, Oncology R&D, GlaxoSmithKline

Jessica Katz, MD, PhD, FACP is a member of the following medical societies: American College of Physicians, American Society of Clinical Oncology, American Society of Hematology

Disclosure: for: Currently employed at GSK.

Coauthor(s)

Kinjal Parikh, MD Resident Physician, Department of Hematology/Oncology, Lankenau Medical Center

Disclosure: Nothing to disclose.

Specialty Editor Board

Francisco Talavera, PharmD, PhD Adjunct Assistant Professor, University of Nebraska Medical Center College of Pharmacy; Editor-in-Chief, Medscape Drug Reference

Disclosure: Received salary from Medscape for employment. for: Medscape.

Chief Editor

Emmanuel C Besa, MD Professor Emeritus, Department of Medicine, Division of Hematologic Malignancies and Hematopoietic Stem Cell Transplantation, Kimmel Cancer Center, Jefferson Medical College of Thomas Jefferson University

Emmanuel C Besa, MD is a member of the following medical societies: American Association for Cancer Education, American Society of Clinical Oncology, American College of Clinical Pharmacology, American Federation for Medical Research, American Society of Hematology, New York Academy of Sciences

Disclosure: Nothing to disclose.

Additional Contributors

S Gerald Sandler, MD, FACP, FCAP Professor of Medicine and Pathology, Director, Transfusion Medicine, Department of Laboratory Medicine, Georgetown University Hospital

S Gerald Sandler, MD, FACP, FCAP is a member of the following medical societies: American Association of Blood Banks, College of American Pathologists, International Society of Blood Transfusion

Disclosure: Nothing to disclose.

Noah S Scheinfeld, JD, MD, FAAD † Assistant Clinical Professor, Department of Dermatology, Weil Cornell Medical College; Consulting Staff, Department of Dermatology, St Luke's Roosevelt Hospital Center, Beth Israel Medical Center, New York Eye and Ear Infirmary; Assistant Attending Dermatologist, New York Presbyterian Hospital; Assistant Attending Dermatologist, Lenox Hill Hospital, North Shore-LIJ Health System; Private Practice

Noah S Scheinfeld, JD, MD, FAAD is a member of the following medical societies: American Academy of Dermatology

Disclosure: Nothing to disclose.

Acknowledgements

John E Godwin, MD, MS Professor of Medicine, Chief Division of Hematology/Oncology, Associate Director, Simmons Cooper Cancer Institute, Southern Illinois University School of Medicine

John E Godwin, MD, MS is a member of the following medical societies: American Association for the Advancement of Science, American Heart Association, and American Society of Hematology

Disclosure: Nothing to disclose.

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