The US Food and Drug Administration has approved AMBELVIST (gadoquatrane), a macrocyclic gadolinium-based contrast agent for contrast-enhanced magnetic resonance imaging (MRI) in adult and pediatric patients, including term neonates. The agent is indicated for the detection and visualization of lesions with abnormal vascularity in the central nervous system and non-central nervous system body regions.
According to Bayer, AMBELVIST is the lowest-dose macrocyclic gadolinium-based contrast agent approved in the US. The recommended dose is 0.01 mmol/kg actual body weight, delivering 0.04 mmol gadolinium/kg body weight. Bayer stated that this dose delivers 60% less gadolinium than macrocyclic gadolinium-based contrast agents containing 0.1 mmol gadolinium/kg body weight and 20% less gadolinium than gadopiclenol, which contains 0.05 mmol gadolinium/kg body weight.
The approval was supported by data from the phase 3 QUANTI clinical studies, which evaluated the safety and diagnostic performance of AMBELVIST in adult and pediatric patients undergoing contrast-enhanced MRI. Bayer reported increased lesion visualization with combined precontrast and postcontrast MRI sets compared with precontrast MRI images alone. In descriptive analyses, lesion visualization scores and the number of lesions identified by blinded independent readers were similar between AMBELVIST administered at 0.01 mmol/kg body weight and tested macrocyclic gadolinium-based contrast agents containing 0.1 mmol gadolinium/kg body weight.
The indication includes MRI of the brain, spine, and associated tissues, as well as the head and neck, thorax, abdomen, pelvis, and musculoskeletal system. Bayer stated that safety and effectiveness in pediatric patients, including term neonates, were supported by adequate and well-controlled studies in adults and by pharmacokinetic and safety data from 93 pediatric patients aged 28 days to younger than 18 years who received a single dose of AMBELVIST.
Christopher Hancock, MD, Director of Neuroradiology at HALO Diagnostics Desert Cities and an investigator in the QUANTI studies, said, “With this approval, we now have an additional option that can help deliver contrast-enhanced images at the lowest macrocyclic [gadolinium-based contrast agent] dose, reducing gadolinium exposure while preserving the clinical information we often need.”
AMBELVIST carries a boxed warning regarding risks associated with intrathecal administration and nephrogenic systemic fibrosis. The product is contraindicated in patients with a history of severe hypersensitivity reactions to AMBELVIST. Additional warnings and precautions include hypersensitivity reactions, gadolinium retention, acute kidney injury, and interference with lesion visualization. The most frequently observed adverse reactions were dizziness, headache, injection-site reactions, nausea, vomiting, feeling hot, paresthesia, and pruritus.
Source: Bayer