title: Management of adverse events in the treatment of patients with immunoglobulin therapy: A review of evidence.
abstract: Immunoglobulin (IG) therapy is actually used for a broad range of diseases including primary and secondary immunodeficiency disorders, and autoimmune diseases. This therapy is available for intravenous (IV) and subcutaneous (SC) administration. The efficacy of the IG therapy has been demonstrated in numerous studies and across different diseases. Generally, IG infusions are well tolerated; however some well-known adverse reactions, ranging from mild to severe, are associated with the therapy. The most common adverse reactions including headache, nausea, myalgia, fever, chills, chest discomfort, skin and anaphylactic reactions, could arise immediately during or after the infusion. Delayed events could be more severe and include migraine headaches, aseptic meningitis, haemolysis renal impairment and thrombotic events. This paper reviews all the potential adverse events related to IG therapy and establishes a comprehensive guideline for the management of these events. Moreover it resumes the opinions and clinical experience of expert endorsers on the utilization of the treatment. Published data were classified into levels of evidence and the strength of the recommendation was given for each intervention according to the GRADE system.
authors.affiliation: Internal Medicine Department, Pitié-Salpetrière Hospital Group, Paris, France. Electronic address: patrick.cherin@psl.aphp.fr.
authors.forename: Patrick
authors.initials: P
authors.lastname: Cherin
authors.affiliation: Internal Medicine Department, CHU, Rouen, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Marie
authors.affiliation: Hematology Department, Hospices Civils de Lyon, Lyon-Sud Hospital, France.
authors.forename: Mauricette
authors.initials: M
authors.lastname: Michallet
authors.affiliation: Hôpitaux Civils de Colmar, Colmar, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Pelus
authors.affiliation: Department of Nephrology, Clinical Immunology, Transplantation, CHU de Nantes, Hôtel Dieu, Nantes, France.
authors.forename: Jacques
authors.initials: J
authors.lastname: Dantal
authors.affiliation: Octapharma, Boulogne Billancourt, France.
authors.forename: Jean-Charles
authors.initials: JC
authors.lastname: Crave
authors.affiliation: Octapharma, Boulogne Billancourt, France.
authors.forename: Jean-Christophe
authors.initials: JC
authors.lastname: Delain
authors.affiliation: Internal Medicine Department, Bordeaux University Hospital Centre, Pessac, France.
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Viallard
mesh_terms: D001327:Autoimmune Diseases / Q000188:drug therapy / Q000628:therapy; D006801:Humans; D007116:Immunization, Passive / Q000009:adverse effects*; D016756:Immunoglobulins, Intravenous / Q000009:adverse effects* / Q000627:therapeutic use; D007153:Immunologic Deficiency Syndromes / Q000188:drug therapy
chemical_list: D016756:Immunoglobulins, Intravenous
keywords: Adverse event management; Clinical practice; Immunoglobulin; Level of evidence; Premedication; Product selection; Safety