FDA Approves Additional Prefilled Syringe Size of Hizentra

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The 50mL/10gm prefilled syringe is expected to be available in early 2024.

The Food and Drug Administration (FDA) has approved a new 50mL/10gm prefilled syringe for Hizentra® (immune globulin subcutaneous [human] 20% liquid).

Hizentra is indicated:

  • As replacement therapy for primary immunodeficiency (PI) in adults and pediatric patients 2 years of age and older (eg, congenital or X-linked agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies). 
  • As maintenance therapy to prevent relapse of neuromuscular disability and impairment in adults with chronic inflammatory demyelinating polyneuropathy (CIDP).

The new 50mL/10gm prefilled syringe is expected to be available in early 2024. Hizentra is currently available in 5mL/1gm, 10mL/2gm, and 20mL/4gm prefilled syringes as well as in 5mL/1gm, 10mL/2gm, 20mL/4gm, and 50mL/10gm vials.

“As part of our promise to meet the needs of people who rely on our life-saving therapies, we recognize the important value of offering people with PI or CIDP a larger prefilled syringe size option to effectively manage their condition,” said Bob Lojewski, Senior Vice President and General Manager, North America, CSL Behring. “We are proud to be at the forefront of delivering effective treatment options that also provide flexibility by allowing those with PI or CIDP to self-administer their treatments based on their specific needs and lifestyles.”


CSL Behring receives FDA approval for Hizentra® (immune globulin subcutaneous [human] 20% liquid) 50mL prefilled syringe. News release. CSL Behring. Accessed April 18, 2023. https://www.prnewswire.com/news-releases/csl-behring-receives-fda-approval-for-hizentra-immune-globulin-subcutaneous-human-20-liquid-50ml-prefilled-syringe-301799492.html.