title: Subcutaneous immunoglobulins: product characteristics and their role in primary immunodeficiency disease.
abstract: Research on the role of subcutaneous immunoglobulin in primary immunodeficiency disease (PIDD) is ongoing. We analyzed pivotal studies for four subcutaneous immunoglobulin products: IGSC 10% (Gammagard(®) Liquid), IGIV-C 10% (Gamunex(®)-C), IGSC 16% (Vivaglobin(®)) and IGSC 20% (Hizentra(®)). To identify similarities and differences between products, we examined infusion parameters, adverse event profiles and improvements in tolerability over time. Maximum volume infused was 30 mL/site for IGSC 10%, 34 mL/site for IGIV-C 10%, 15 mL/site for IGSC 16% and 25 mL/site for IGSC 20%. Maximum number of simultaneous infusion sites was 10 for IGSC 10%, 8 for IGIV-C 10%, 6 for IGSC 16% and 4 for IGSC 20%. Local adverse reaction rate per infusion was 0.02 for IGSC 10%, 0.59 for IGIV-C, 0.49 for IGSC 16% and 0.58 for IGSC 20%. IGSC products have similar efficacy profiles; however, their tolerability profiles vary. Reasons for these differences are unknown and warrant further research.
authors.affiliation: IMMUNOe International Research Centers, Centennial, CO, USA. melamedi@immunoe.com
authors.forename: Isaac
authors.initials: I
authors.lastname: Melamed
authors.forename: Alessandro
authors.initials: A
authors.lastname: Testori
authors.forename: Zvi
authors.initials: Z
authors.lastname: Spirer
mesh_terms: D000818:Animals; D006801:Humans; D007136:Immunoglobulins / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D007153:Immunologic Deficiency Syndromes / Q000628:therapy*; D055104:Infusions, Subcutaneous; D040521:Subcutaneous Tissue / Q000276:immunology
chemical_list: D007136:Immunoglobulins