Muscle & Nerve · 2019 · 12 citations · 33 references
MedicinePharmacologyPharmacotherapyAutoimmunityClinical ImmunologyImmunopathologyImmunoglobulin DisordersMyasthenia GravisAdverse Drug EventsImmune Globulin TherapyPharmacovigilance In ImmunotherapyTotal Dose
INTRODUCTION: Although intravenous immune globulin (IVIg) is used to treat patients in the outpatient setting, there is limited documentation addressing the safety of this practice. METHODS: Retrospective analysis of 438 patients with neuromuscular diseases receiving IVIg in an outpatient setting. RESULTS: Adverse events (AE) overall occurred in 16.9% of patients. Headache was the most common AE, noted in 11.6% of patients. Serious AEs occurred in 0.91% of patients; aseptic meningitis was the only one noted. Multivariate analyses identified the following risk factors for AEs: first-lifetime course of IVIg, higher dose per course of IVIg, diagnosis of myasthenia gravis, women, and younger age. DISCUSSION: Intravenous immune globulin is generally safe to administer in an outpatient setting. Women, myasthenia gravis patients, and those receiving their first course or a higher total dose of IVIg are at an increased risk of experiencing an AE.
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No Adjustments Are Needed for Multiple Comparisons
Kenneth J. Rothman · Epidemiology · 1990 · 5.8K citations