Back to Search
Start Over
Tolerability of subcutaneous immunoglobulin 20%, Ig20Gly, in pediatric patients with primary immunodeficiencies
- Source :
- Immunotherapy. 11:397-406
- Publication Year :
- 2019
- Publisher :
- Future Medicine Ltd, 2019.
-
Abstract
- Aim: To assess Ig20Gly tolerability in pediatric patients with primary immunodeficiencies. Patients & methods: Infusion parameters and tolerability were analyzed in pediatric patients (aged 2–5 years [n = 6], 6–11 years [n = 22] and 12–17 years [n = 22]) receiving Ig20Gly in two Phase II/III trials. Results: Of 2624 Ig20Gly infusions, >99% did not require any rate reduction, interruption or discontinuation due to adverse events (AEs). Median maximum infusion rates and volumes/site were higher in patients 12–17 years of age (30 ml/h/site; 30 ml/site) versus 6–11 years (20 ml/h/site; 15 ml/site) and 2–5 years (18 ml/h/site; 14 ml/site). Rates of causally related systemic and local AEs (0.009 and 0.063 AEs/infusion) were low. Conclusion: Ig20Gly infused at relatively high rates and volumes was well tolerated in children.
- Subjects :
- Male
0301 basic medicine
medicine.medical_specialty
Adolescent
Injections, Subcutaneous
Primary Immunodeficiency Diseases
Immunology
Subcutaneous immunoglobulin
Infusions, Subcutaneous
Gastroenterology
03 medical and health sciences
0302 clinical medicine
Internal medicine
medicine
Humans
Immunology and Allergy
In patient
Child
Adverse effect
High rate
business.industry
Rate reduction
Immunoglobulins, Intravenous
Discontinuation
030104 developmental biology
Oncology
Tolerability
Child, Preschool
030220 oncology & carcinogenesis
Female
business
Subjects
Details
- ISSN :
- 17507448 and 1750743X
- Volume :
- 11
- Database :
- OpenAIRE
- Journal :
- Immunotherapy
- Accession number :
- edsair.doi.dedup.....ebb29877e1978fbf99f8835c210e9079