{
  "abstract": "Background and Importance Intravenous immunoglobulins (IVIg) are widely used for the treatment of autoimmune and immune-mediated diseases. However, their high cost and limited supply require rational and evidence-based use. Current guidelines from regulatory agencies define specific approved indications, yet off-label use remains common. Evaluating prescribing patterns helps to identify deviations from recommendations and promote appropriate utilisation of IVIg therapy.Aim and Objectives To assess the appropriateness of IVIg prescriptions for autoimmune diseases by comparing actual clinical use with indications approved by the national regulatory authority. Secondary objectives included analysing treatment duration, clinical response, adverse effects, and prescribing medical specialties.Material and Methods A four-year retrospective observational study (January 2020–December 2024) included all patients who initiated IVIg therapy during the study period. Data were collected from electronic medical records and pharmacy intravenous preparation management software. Variables included sex, age, weight, indication, treatment duration, clinical improvement, adverse effects, and prescribing department. Indications were classified as ‘on-label’ (according to the approved product information) or ‘off-label.’Results A total of 98 patients were included, 50% female, with a mean age of 61±18.3 years and mean weight of 75.2±16.6 kg. The mean treatment duration was 3.1±5 days. Adverse reactions occurred in 9 cases (9.1%), mainly mild to moderate headache (7 cases), paraesthesia (1), and non-pruritic rash (1). Prescribing departments were neurology (47%), internal medicine (34.6%), pneumology (5.2%), emergency (5.2%), nephrology (3%), rheumatology (3%), traumatology (1%), and infectious diseases (1%). On-label indications accounted for 69 prescriptions (70.4%), including immunodeficiency syndromes (46.4%), Guillain-Barré syndrome (20.3%), chronic inflammatory demyelinating polyneuropathy (15.9%), immune thrombocytopenia (8.7%), multifocal motor neuropathy (7.3%), and Kawasaki disease (1.4%). Clinical improvement was documented in 49 cases, while 8 showed no improvement; data were missing in 12. Off-label use (29.6%) included myasthenia gravis (51.7%), lupus erythematosus (6.9%), neuromyelitis optica (6.9%), and other rare conditions (34.5%). Clinical improvement was recorded in 14 off-label cases.Conclusion and Relevance Most IVIg prescriptions were in line with approved indications, possibly influenced by product shortages during the study period. Off-label use was frequent in conditions with substantial supporting evidence, particularly myasthenia gravis. Outcomes were favourable despite documentation gaps. IVIg showed good safety with mild adverse events, supporting its use in selected patients.Conflict of Interest No conflict of interest",
  "authors": [
    {
      "affiliations": [
        "Hospital General Universitario Reina Sofia, Farmacia Hospitalaria, Murcia, Spain"
      ],
      "name": "R Guzman Laiz"
    },
    {
      "affiliations": [
        "Hospital General Universitario Reina Sofia, Farmacia Hospitalaria, Murcia, Spain"
      ],
      "name": "P Pascual García"
    },
    {
      "affiliations": [
        "Hospital General Universitario Reina Sofia, Farmacia Hospitalaria, Murcia, Spain"
      ],
      "name": "E Santos Lopez"
    },
    {
      "affiliations": [
        "Hospital General Universitario Reina Sofia, Farmacia Hospitalaria, Murcia, Spain"
      ],
      "name": "I García Masegosa"
    },
    {
      "affiliations": [
        "Hospital General Universitario Reina Sofia, Farmacia Hospitalaria, Murcia, Spain"
      ],
      "name": "A Herreros Fernández"
    },
    {
      "affiliations": [
        "Hospital General Universitario Reina Sofia, Farmacia Hospitalaria, Murcia, Spain"
      ],
      "name": "R Añez Castaño"
    },
    {
      "affiliations": [
        "Hospital General Universitario Reina Sofia, Farmacia Hospitalaria, Murcia, Spain"
      ],
      "name": "M Almanchel Rivadeneyra"
    },
    {
      "affiliations": [
        "Hospital General Universitario Reina Sofia, Farmacia Hospitalaria, Murcia, Spain"
      ],
      "name": "E Urbieta Sanz"
    }
  ],
  "title": "5PSQ-072 Evaluation of intravenous immunoglobulin use in autoimmune diseases: are prescriptions aligned with current recommendations?",
  "uid": "fb82acc8-bfd7-5f80-9eb8-53f5b12cff35"
}