PMID- 36114118 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230610 IS - 2531-1387 (Electronic) IS - 2531-1379 (Print) IS - 2531-1379 (Linking) VI - 45 IP - 2 DP - 2023 Apr-Jun TI - Immediate adverse events to intravenous immunoglobulin in pediatric patients with inborn errors of immunity: A longitudinal study with a pre-infusion protocol. PG - 253-258 LID - S2531-1379(22)00097-9 [pii] LID - 10.1016/j.htct.2022.06.009 [doi] AB - INTRODUCTION: Immunoglobulin represents the main therapy for patients with inborn errors of immunity (IEI) and it is a safe procedure, but adverse events (AEs) can occur with variable frequencies. OBJECTIVE: To evaluate the frequency of immediate AEs to intravenous immunoglobulin (IVIG) regular therapy in a pediatric cohort with IEI after a pre-IVIG infusion protocol. METHODS: This was a longitudinal study from 2011 to 2019 at a tertiary pediatric hospital in Brazil. RESULTS: A total of 1736 infusions were studied in 70 patients with IEI, 46 (65.7%) of whom were males and whose median age was 5.8 years old (range: 6 mo - 18 yo). Seven different brands of IVIG were used with the median loading dose of 0.57g/kg (range: 0.23 - 0.88g/Kg). According to the protocol, pre-medication and step-up infusion rate, were performed in 1305 (75.2%) infusions. Immediate AEs were noted in 10 children (14.3%) and in 22 (1.2%) infusions. Skin reactions (rash or urticaria) were the most common AE with 14 episodes (0.8% of all infusions). Almost all AEs were mild (19/86.4%), with no severe ones being observed. The majority of the AEs (81.8%) was identified at a 0.04ml/kg/min infusion rate. Gender, age at first infusion, presence of infection on the infusion day and change of the IVIG brand were evaluated and none of them were associated with AEs. CONCLUSION: The low frequency of immediate AEs in children with IEI highlights the safety and tolerability of intravenous immunoglobulin replacement with the procedures established at our center. CI - Copyright (c) 2022 Associacao Brasileira de Hematologia, Hemoterapia e Terapia Celular. Published by Elsevier Espana, S.L.U. All rights reserved. FAU - Antunes, Thales Silva AU - Antunes TS AD - Hospital da Crianca de Brasilia Jose Alencar (HCB), Brasilia, DF, Brazil. Electronic address: thalesilvantunes@hotmail.com. FAU - Melo, Karina Mescouto AU - Melo KM AD - Hospital da Crianca de Brasilia Jose Alencar (HCB), Brasilia, DF, Brazil. FAU - Valente, Claudia Franca Cavalcante AU - Valente CFC AD - Hospital da Crianca de Brasilia Jose Alencar (HCB), Brasilia, DF, Brazil. FAU - Tavares, Fabiola Scancetti AU - Tavares FS AD - Hospital da Crianca de Brasilia Jose Alencar (HCB), Brasilia, DF, Brazil. LA - eng PT - Journal Article DEP - 20220808 PL - Brazil TA - Hematol Transfus Cell Ther JT - Hematology, transfusion and cell therapy JID - 101725732 PMC - PMC10244234 OTO - NOTNLM OT - Adverse events OT - Immunoglobulin OT - Inborn errors of immunity OT - Primary immunodeficiency COIS- Conflicts of interest The authors declare no conflicts of interest EDAT- 2022/09/17 06:00 MHDA- 2022/09/17 06:01 PMCR- 2022/08/08 CRDT- 2022/09/16 22:06 PHST- 2022/02/06 00:00 [received] PHST- 2022/05/04 00:00 [revised] PHST- 2022/06/24 00:00 [accepted] PHST- 2022/09/17 06:01 [medline] PHST- 2022/09/17 06:00 [pubmed] PHST- 2022/09/16 22:06 [entrez] PHST- 2022/08/08 00:00 [pmc-release] AID - S2531-1379(22)00097-9 [pii] AID - 10.1016/j.htct.2022.06.009 [doi] PST - ppublish SO - Hematol Transfus Cell Ther. 2023 Apr-Jun;45(2):253-258. doi: 10.1016/j.htct.2022.06.009. Epub 2022 Aug 8.