Available online 7 July 2025

Immunoglobulin replacement therapy is a fundamental treatment option to protect against infection for most patients with a primary deficiency in antibody production. Facilitated subcutaneous immunoglobulin (fSCIG) 10% is an immunoglobulin replacement therapy that uses recombinant human hyaluronidase to enhance immunoglobulin dispersion and absorption. This review provides an overview of data published to date relating to the safety and tolerability of fSCIG 10% for the treatment of primary immunodeficiency diseases in pediatric patients. Eight studies (199 pediatric patients) were included for discussion. fSCIG 10% displays a low rate of treatment-related systemic adverse events, and the risk of treatment-related local adverse events diminishes with increased treatment exposure. The reduced number of needle sticks required for fSCIG 10% administration than for conventional subcutaneous immunoglobulin may offer advantages for patients with immune disorders that have compromised their skin integrity, and for those who experience needle phobia and treatment-associated anxiety. Studies evaluating prospective, patient-centric data collected on the experience of such patients may be a valuable addition to the evidence base. Discussion of fSCIG 10% as a potential treatment option between families and health care professionals will enhance individualized treatment plans and shared decision making, which are important considerations for patients with primary immunodeficiency diseases.

Facilitated subcutaneous immunoglobulin

Hyaluronidase

Immunogenicity

Inborn errors of immunity

Pediatric

Primary immunodeficiency diseases

Safety

Tolerability

Facilitated Immunoglobulin Administration Registry and Outcomes

Facilitated subcutaneous immunoglobulin

Intravenous immunoglobulin

Postauthorization safety study

Primary immunodeficiency disease

Retrospective Chart Study of Facilitated Subcutaneous Immunoglobulin Usage in Paediatric Patients with Primary or Secondary Immunodeficiency Diseases

Recombinant human hyaluronidase

Subcutaneous immunoglobulin

Secondary immunodeficiency

Treatment-emergent adverse event

© 2025 The Authors. Published by Elsevier Inc. on behalf of the American Academy of Allergy, Asthma & Immunology.