A new intravenous immunoglobulin (BIVIGAM^®) for primary humoral immunodeficiency

Abstract

Human immunoglobulin G administered intravenously or subcutaneously is used to prevent infections in patients with primary antibody deficiencies. Intravenous immunoglobulin (IVIG) preparations have improved over the years and have evolved from immune serum globulin that is injected intramuscularly or subcutaneously at relatively low doses (100-150 mg/kg per month). IVIG products are currently available in different concentrations and compositions and can deliver up to 2 g/kg or more per infusion with few side effects. This report describes the properties and clinical trial results of BIVIGAM^®, a new IVIG product. We also discuss how improvements in intravenous immunoglobulin manufacturing and formulation have improved clinical outcomes in patients with primary immunodeficiencies, also benefiting patients with other immunological disorders.

Keywords::

• antibody deficiency treatment
• immunodeficiency treatment
• immunoglobulin efficacy
• immunoglobulin safety
• intravenous immunoglobulin
• primary immunodeficiency

Acknowledgements

Editorial assistance was provided by JA Hooper, Biocatalyst Research LLC, 217 Camelot Drive, Liberty, Missouri, USA.

Financial & competing interests disclosure

The preparation of this manuscript was supported, in part, by editorial assistance sponsored by Biotest Pharmaceuticals Corporation. RL Wasserman has been an investigator and a consultant for Biotest, ADMA, Baxter Healthcare, CSL Behring and Kedrion. The author has also been a speaker for Baxter Healthcare and CSL Behring, an investigator for Korean Green Cross, and a consultant for BPL. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Key issues

• Intravenous immunoglobulin is used to provide IgG antibodies to primary immunodeficiency patients who are unable to make it on their own. It is also used as an immunomodulator.

• BIVIGAM^® is a modern intravenous immunoglobulin product approved for the treatment of primary immunodeficiency disease that is safe, effective and well tolerated.

• Because of increased use of IgG therapy, BIVIGAM will be an important component of the supply.

Notes