Safety of gadoxetate disodium: results from six clinical phase IV studies in 8194 patients

Abstract

BackgroundSafety data on routine clinical use of gadoxetate disodium for liver magnetic resonance imaging (MRI) is not reported yet.PurposeTo assess the safety profile of gadoxetate disodium for liver MRI in the routine clinical setting.Material and MethodsSix multicenter studies were performed in Europe, USA, Australia, and Asia to evaluate the safety and efficacy of gadoxetate disodium (Primovist®/Eovist®) enhanced liver MRI. Patients received a single intravenous bolus injection of the standard approved dose of 0.025 mmol/kg body weight (0.1 mL/kg). The number of patients, the characteristics of adverse events, related adverse events, and serious adverse events were analyzed.ResultsA total of 8194 patients were included in the database. A total of 141 patients (1.7%) reported 230 AEs of which 129 were considered being related to the use of gadoxetate disodium by the investigators. None of the AEs in the pediatric population (n = 52) were related. The most frequent AEs independent of relationship to the drug included dyspnea (25/0.31%), nausea (22/0.27%), liver disorders (13/0.16%), and renal disorders (9/0.11%). Nine related SAEs were recorded. No patient died during the studies.ConclusionGadoxetate disodium for liver MRI is safe and well tolerated in the routine clinical setting.

Metal-Based Complexes as Pharmaceuticals for Molecular Imaging of the Liver

“…The frequency of adverse events is comparable to that reported for Gd-EOB-DTPA [62]. An evaluation of six clinical phase IV studies reported that a total of 1.7% patients experienced at least one adverse event, the most frequent of which are dyspnea, nausea, and liver and renal disorders, concluding that Gd-EOB-DTPA is generally safe and well tolerated [63].…”

Comparison of The Gadoxetic Acid and Gadopentate Dimeglumine Efficiency for Determining Liver Metastases by An Enhanced MRI of Patients with Gastrointestinal Malignancies

“…However, the study of patients with moderate or severe renal insufficiency showed no systemic fibrosis progression over a retrospective 2-year period (13). Dyspnea, one of the most common side effects following administration of contrast media, is lower during the administration of gadoxetic acid (14).…”

Trends in contrast media research the last 100 years

“…In the group of clinical studies on Gd-CM in Acta Radiologica, several phase IV, i.e. postmarketing surveillance trials, have been published on gadobutrol (Gadovist) (49), gadoterate meglumine (Dotarem) (50), and gadoxetate disodium acid (Primovist/Eovist) (51). These are all large-scale studies with >1600 patients describing the safety profile of the CM.…”