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| Content Provider | Springer Nature Link |
|---|---|
| Author | Patel, Niraj C. Gallagher, Joel L. Ochs, Hans D. Prescott Atkinson, Thomas Wahlstrom, Justin Dorsey, Morna Bonilla, Francisco A. Heimall, Jennifer Kobrynski, Lisa Morris, David Haddad, Elie |
| Copyright Year | 2015 |
| Abstract | 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.A retrospective chart review involved 88 PIDD infants and children less than 5 years of age who received Hizentra®.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.Hizentra® is effective in preventing infections, and is well tolerated in children less than age 5 years. |
| Starting Page | 558 |
| Ending Page | 565 |
| Page Count | 8 |
| File Format | |
| ISSN | 02719142 |
| Journal | Journal of Clinical Immunology |
| Volume Number | 35 |
| Issue Number | 6 |
| e-ISSN | 15732592 |
| Language | English |
| Publisher | Springer US |
| Publisher Date | 2015-09-04 |
| Publisher Place | New York |
| Access Restriction | One Nation One Subscription (ONOS) |
| Subject Keyword | Immunoglobulin Subcutaneous Immunodeficiency Children Safety Efficacy Immunology Infectious Diseases Internal Medicine Medical Microbiology |
| Content Type | Text |
| Resource Type | Article |
| Subject | Immunology and Allergy Immunology |
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