About: Subcutaneous Immunoglobulin Replacement Therapy with Hizentra® is Safe and Effective in Children Less Than 5 Years of Age

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	Subcutaneous Immunoglobulin Replacement Therapy with Hizentra® is Safe and Effective in Children Less Than 5 Years of Age
Creator	Dorsey, Morna Morris, David Bonilla, Francisco Haddad, Elie Ochs, Hans Wahlstrom, Justin Atkinson, Thomas Gallagher, Joel Heimall, Jennifer Kobrynski, Lisa Patel, Niraj
Source	PMC
abstract	BACKGROUND: Hizentra® (IGSC 20 %) is a 20 % liquid IgG product approved for subcutaneous administration in adults and children 2 years of age and older who have primary immunodeficiency disease (PIDD). There is limited information about the use of IGSC 20 % in very young children including those less than 5 years of age. METHODS: A retrospective chart review involved 88 PIDD infants and children less than 5 years of age who received Hizentra®. RESULTS: The mean age at the start of Hizentra® was 34 months (range 2 to 59 months). IGSC 20 % was administered weekly to 86 infants (two additional infants received twice weekly and three times weekly infusions, respectively) and included an average of 63 infusions (range 6–182) for an observation period up to 45.5 months. Infusion by manual delivery occurred in 15 patients. The mean dose was 674 mg/kg/4 weeks. The mean IgG level was 942 mg/dL while on IGSC 20 %, compared to a mean trough IgG level of 794 mg/dL (p < 0.0001) during intravenous or subcutaneous IgG administration prior to IGSC 20 %. Average infusion time was 47 (range 5–120) minutes, and the median number of infusion sites was 2 (range 1–4). Local reactions were mostly mild and observed in 36/88 (41 %) children. No serious adverse events were reported. A significant increase in weight percentile (7 % ± 19.2, p = 0.0012) among subjects was observed during IGSC 20 % administration. The rate of serious bacterial infections was 0.067 per patient-year while receiving IGSC 20 %, similar to previously reported efficacy studies. CONCLUSIONS: Hizentra® is effective in preventing infections, and is well tolerated in children less than age 5 years.
has issue date	2015-08-17(xsd:dateTime)
bibo:doi	10.1007/s10875-015-0190-0
bibo:pmid	26336818
has license	no-cc
sha1sum (hex)	7f3288fd697f222aa10a3c09580c1646ada95fb9
schema:url	https://doi.org/10.1007/s10875-015-0190-0
resource representing a document's title	Subcutaneous Immunoglobulin Replacement Therapy with Hizentra® is Safe and Effective in Children Less Than 5 Years of Age
has PubMed Central identifier	PMC4572047
has PubMed identifier	26336818
schema:publication	J Clin Immunol
resource representing a document's body	covid:7f3288fd697f222aa10a3c09580c1646ada95fb9#body_text
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