title: Immediate infusion-related adverse reactions to intravenous immunoglobulin in a prospective cohort of 1765 infusions.
abstract: Intravenous immunoglobulin (IVIG) is increasingly recommended for many diseases apart from primary immunodeficiency diseases (PID). Although effective and safe, adverse reactions may occur. We conducted a 2-year prospective observational study in 117 patients with PID who received regular IVIG replacement therapy at a median dose of 600 mg/kg every 3 to 4 weeks to examine IVIG's adverse effects; 1765 infusions were performed (mean=15/patient) in 75 males and 42 females (aged 3 months to 77 years) in 3 groups: ≤ 9 years (34.2%), 10-19 years (26.5%), and ≥ 20 years (39.3%). Fifty patients had common variable immunodeficiency (CVID), 11 had X-linked agammaglobulinemia (XLA), and 55 had other immune system disorders. The drugs administered were Octagam® (49.1%), Tegeline® (17.3%), Imunoglobulin® (18.6%), Flebogama® (12.9%), Vigam® (1.2%), and Kiovig® (0.4%). Immediate infusion-related adverse reactions occurred in the cases of 38 out 1765 infusions (2.15%, IC95% 1.53%-2.94%), which were classified as mild (81.6%), moderate (10.5%), or severe (7.9%). Time until reaction ranged from 10 to 240 min (mean = 85.7, median = 60). Reaction rates were similar across age groups. The most common reactions were malaise, headache, and abdominal pain. Reported severe events were tightness of the throat and seizure. All symptoms improved with temporary or complete IVIG interruption and symptomatic medications. Sixteen of 38 reactions to infusions occurred in the presence of an acute infection (p=0.09). Tegeline® represented a greater reaction risk factor than Octagam® (p < 0.001). These results indicate that IVIG infusion can be considered a safe procedure. Low reaction incidence and few severe immediate infusion-related adverse reactions were observed.
authors.affiliation: Division of Allergy Clinical Immunology and Rheumatology, Department of Pediatrics, Federal University of São Paulo (UNIFESP-EPM), Rua dos Otonis 725, São Paulo, SP 04025-002, Brazil. Electronic address: daniellibichuete@gmail.com.
authors.forename: Danielli C
authors.initials: DC
authors.lastname: Bichuetti-Silva
authors.affiliation: Division of Allergy Clinical Immunology and Rheumatology, Department of Pediatrics, Federal University of São Paulo (UNIFESP-EPM), Rua dos Otonis 725, São Paulo, SP 04025-002, Brazil. Electronic address: nandafurlan@hotmail.com.
authors.forename: Fernanda P
authors.initials: FP
authors.lastname: Furlan
authors.affiliation: Division of Allergy Clinical Immunology and Rheumatology, Department of Pediatrics, Federal University of São Paulo (UNIFESP-EPM), Rua dos Otonis 725, São Paulo, SP 04025-002, Brazil. Electronic address: aimeenobre@yahoo.com.br.
authors.forename: Fernanda A
authors.initials: FA
authors.lastname: Nobre
authors.affiliation: Division of Allergy Clinical Immunology and Rheumatology, Department of Pediatrics, Federal University of São Paulo (UNIFESP-EPM), Rua dos Otonis 725, São Paulo, SP 04025-002, Brazil. Electronic address: milatmp@hotmail.com.
authors.forename: Camila T M
authors.initials: CT
authors.lastname: Pereira
authors.affiliation: Division of Allergy Clinical Immunology and Rheumatology, Department of Pediatrics, Federal University of São Paulo (UNIFESP-EPM), Rua dos Otonis 725, São Paulo, SP 04025-002, Brazil. Electronic address: tessarachel@gmail.com.
authors.forename: Tessa R T
authors.initials: TR
authors.lastname: Gonçalves
authors.affiliation: Division of Allergy Clinical Immunology and Rheumatology, Department of Pediatrics, Federal University of São Paulo (UNIFESP-EPM), Rua dos Otonis 725, São Paulo, SP 04025-002, Brazil. Electronic address: ma_rianinha@yahoo.com.br.
authors.forename: Mariana
authors.initials: M
authors.lastname: Gouveia-Pereira
authors.affiliation: Division of Allergy Clinical Immunology and Rheumatology, Department of Pediatrics, Federal University of São Paulo (UNIFESP-EPM), Rua dos Otonis 725, São Paulo, SP 04025-002, Brazil. Electronic address: rota72@hotmail.com.
authors.forename: Rafael
authors.initials: R
authors.lastname: Rota
authors.affiliation: Division of Allergy Clinical Immunology and Rheumatology, Department of Pediatrics, Federal University of São Paulo (UNIFESP-EPM), Rua dos Otonis 725, São Paulo, SP 04025-002, Brazil. Electronic address: lusinete_tavares@gmail.com.
authors.forename: Lusinete
authors.initials: L
authors.lastname: Tavares
authors.affiliation: Division of Allergy Clinical Immunology and Rheumatology, Department of Pediatrics, Federal University of São Paulo (UNIFESP-EPM), Rua dos Otonis 725, São Paulo, SP 04025-002, Brazil. Electronic address: juliana.mazzuccheli@gmail.com.
authors.forename: Juliana T L
authors.initials: JT
authors.lastname: Mazzucchelli
authors.affiliation: Division of Allergy Clinical Immunology and Rheumatology, Department of Pediatrics, Federal University of São Paulo (UNIFESP-EPM), Rua dos Otonis 725, São Paulo, SP 04025-002, Brazil. Electronic address: beacarvalho@terra.com.br.
authors.forename: Beatriz T
authors.initials: BT
authors.lastname: Costa-Carvalho
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D005260:Female; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000009:adverse effects* / Q000627:therapeutic use*; D007153:Immunologic Deficiency Syndromes / Q000188:drug therapy*; D007223:Infant; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D012307:Risk Factors; D055815:Young Adult
chemical_list: D016756:Immunoglobulins, Intravenous
keywords: Adverse reactions; Antibody; Infusion-related; Intravenous immunoglobulin; Primary immunodeficiency