The ferumoxytol injection is indicated for adults with known or suspected malignant brain neoplasms to visualize lesions with a disrupted blood-brain barrier.
The US Food and Drug Administration has approved Ferabright (ferumoxytol injection), an iron-based contrast agent for magnetic resonance imaging (MRI) of the brain, according to manufacturer Azurity Pharmaceuticals.
The agent is indicated for use in adults with known or suspected malignant brain neoplasms to visualize lesions where the blood-brain barrier is disrupted.
“Ferabright is an advanced superparamagnetic iron oxide nanoparticle contrast agent engineered for high relaxivity,” says Ronald Scarboro, CEO of Azurity Pharmaceuticals, in a release. “It significantly enhances image contrast and precision in brain tumor delineation compared to non-contrast MRI, offering clinicians a new tool for diagnostic imaging and improved patient care.”
According to a release from the company, Ferabright-enhanced MRI demonstrated improved visualization of primary and secondary brain neoplasms in a clinical trial when compared with pre-contrast imaging. As an iron-based agent, it is processed through the body’s natural iron metabolism pathways, which may reduce concerns related to the long-term retention associated with other types of contrast agents. The agent is also suitable for patients with renal insufficiency.
The agent’s long half-life provides an extended imaging window, which could support more flexible MRI protocols without requiring multiple contrast administrations.
“Ferumoxytol expands our MRI toolkit and provides an option for patients who are either contraindicated for or decline gadolinium,” says Csanad Varallyay, MD, PhD, a neuroradiologist based in Portland, Oregon, in a release.
The prescribing information for Ferabright includes a warning for fatal and serious hypersensitivity reactions, including anaphylaxis. The agent is contraindicated in patients with a known hypersensitivity to ferumoxytol, any of its components, or any other intravenous iron products.
Ferabright will be supplied in single-dose vials for intravenous infusion administered over at least 15 minutes.
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