What Was Approved?
On June 12, 2026, the U.S. Food and Drug Administration approved Ambelvist (gadoquatrane) for use with magnetic resonance imaging, or MRI, to help detect and visualize lesions with abnormal vascularity.
It is approved for adults and pediatric patients, including term neonates.
Where Can Ambelvist Be Used?
Ambelvist may be used for MRI of the:
- Brain and spine
- Head and neck
- Chest
- Abdomen
- Pelvis
- Musculoskeletal system
It is a diagnostic contrast agent, not a treatment for the underlying condition.
How Is Ambelvist Given?
The FDA-approved dose is 0.01 mmol/kg, equivalent to 0.1 mL/kg, given by intravenous injection.
Administration is performed by healthcare professionals in connection with an MRI study.
Does Ambelvist Have a Boxed Warning?
Yes.
The prescribing information includes a boxed warning for two major risks:
- Serious harm from intrathecal use; Ambelvist is not approved for injection into the spinal canal.
- Nephrogenic systemic fibrosis (NSF) in patients with significantly impaired gadolinium elimination, especially those with severe kidney disease or acute kidney injury.
Kidney function should be assessed when clinically appropriate before administration.
What Other Safety Issues Are Important?
The FDA label also warns about:
- Serious hypersensitivity reactions
- Gadolinium retention in the body
- Acute kidney injury
- Possible effects on lesion visualization
The most frequently reported adverse reactions in clinical studies included dizziness, headache, injection-site reactions, nausea, vomiting, feeling hot, tingling sensations, and itching.
Bottom Line
Ambelvist (gadoquatrane) is a newly FDA-approved gadolinium-based contrast agent used with MRI to improve visualization of certain lesions with abnormal vascularity.
It is not a treatment itself, and its use requires appropriate screening and professional administration, particularly in patients with impaired kidney function.
Sources
- U.S. Food and Drug Administration (FDA) — Novel Drug Approvals for 2026.
- U.S. Food and Drug Administration (FDA) — Ambelvist (gadoquatrane) Prescribing Information, revised June 2026.