Gadopiclenol, a New Macrocyclic Gadolinium-Based Contrast Agent, Gets FDA Approval

The Food and Drug Administration (FDA) has approved 2 new macrocyclic gadolinium-based contrast agents (GBCAs), Elucirem^™ (gadopiclenol) and Vueway^™ (gadopiclenol), for use with magnetic resonance imaging (MRI) in patients 2 years of age and older to detect and visualize lesions with abnormal vascularity in the central nervous system (CNS; brain, spine and associated tissues) and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).

The approval of gadopiclenol was based on data from the phase 3 PICTURE (ClinicalTrials.gov Identifier: NCT03996447) and PROMISE (ClinicalTrials.gov Identifier: NCT03986138) studies, which evaluated the efficacy and safety of gadopiclenol for CNS MRI and body MRI, respectively, in 1047 patients with doses ranging from 0.025mmol/kg to 0.3mmol/kg.

Results from both studies demonstrated that gadopiclenol-enhanced MRI at the recommended dose of 0.05mmol/kg demonstrated superiority vs unenhanced MRI, and was noninferior to gadobutrol 0.1mmol/kg, as assessed in 3 lesion visualization coprimary criteria: border delineation, internal morphology and contrast enhancement. In the PICTURE trial, readers preferred the quality of visualization obtained with a half dose of gadopiclenol vs a full dose of gadobutrol.

As for safety, gadopiclenol carries a Boxed Warning associated with an increased risk of nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with noncontrasted MRI or other modalities. Patients with chronic, severe kidney disease (glomerular filtration rate <30mL/min/1.73m²) or acute kidney injury appear to have the highest risk for NSF. Patients should be screened for acute kidney injury and other conditions that may reduce renal function.

There were no major safety signals reported in either adults or pediatric patients with gadopiclenol. The most common adverse reactions reported were injection site pain, headache, nausea, injection site warmth, injection site coldness, dizziness, and localized swelling.

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