Hizentra for the treatment of primary immunodeficiency

Abstract

Immunoglobulin (IgG) replacement therapy has been the cornerstone of treatment for primary immunodeficiency disease for nearly 60 years. During this time, research has continually refined the target IgG trough level and IgG replacement dosages to allow patients with primary immunodeficiency disease to achieve effective protection from infection. Manufacturers have also improved IgG formulations to allow patients to receive clinically beneficial dosages of IgG replacement with improved safety and tolerability. This review will introduce Hizentra^®, a highly concentrated (20%) IgG solution for subcutaneous (sc.) infusion, discuss its manufacturing process and pharmacokinetic profile and review its tolerability and efficacy data as evaluated in clinical trials. New highly concentrated sc. IgG products may improve patient quality of life and adherence to therapy because of the flexible dosing options, fewer infusion sites and less infusion time, compared with less concentrated sc. IgG products, resulting in favorable patient outcomes consistent with higher steady-state IgG levels.

Keywords::

• Hizentra
• immunoglobulin
• primary immunodeficiency
• subcutaneous immunoglobulin

Acknowledgements

Medical editorial support was provided by LM Havran and RH Sayce at Complete Publication Solutions, LLC; this support was funded by CSL Behring, LLC.

Financial & competing interests disclosure

Apart from the abovementioned writing assistance, RL Wasserman has served as a consultant for ADMA Biologics, Baxter, CSL Behring, Biotest, BPL, the Korean Green Cross, Kedrion and Therapure; has served as an investigator for ADMA Biologics, Baxter, CSL Behring, BPL and Kedrion and has served as a speaker for Baxter and CSL Behring. 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.

Key issues

• Long-term Hizentra administration is effective, safe and well-tolerated in patients with primary immunodeficiency disease of all ages.

• Hizentra use may be associated with improvement in the clinical outcomes of patients with primary immunodeficiency disease resulting from adherence to treatment facilitated by the flexibility of the many dosing options available.

• Hizentra’s highly concentrated IgG formulation (20%) should enable patients to receive their prescribed IgG therapy doses more efficiently with lower infusion volumes and fewer infusion sites required.

• Hizentra is the only subcutaneous immunoglobulin indicated for weekly or biweekly administration.

Notes