# Gadobutrol

Source: https://onco.cc/drugs/gadobutrol/  
OnCo record `gadobutrol` (Imaging agent). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A widely used MRI dye given into a vein. Its American licence includes brain and spine scans and breast MRI to see how far a breast cancer extends.

## Summary

The FDA label (Bayer, NDA 201277, first approved 14 March 2011) covers MRI of the central nervous system "to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity", MRI of the breast "to assess the presence and extent of malignant breast disease in adult patients", MR angiography and cardiac MRI. A generic gadobutrol, GE Healthcare's Pixxoscan, was approved under ANDA 215957 on 29 June 2026. ATC V08CA09. Like every gadolinium-based contrast agent in the United States, its label carries a boxed warning on the risks of intrathecal use and nephrogenic systemic fibrosis, a thickening of skin and organs seen in people with severe kidney disease.

## Fields

- Kind: Imaging agent
- Status: approved
- Last checked: 2026-11-04
- Also known as: gadobutrol; Gadavist; Pixxoscan
- Tags: contrast-agents-gaps-2026-11; diagnostic
- Brand: Gadavist
- Modality: Gadolinium-based contrast agent for MRI (intravenous)
- Mechanism: A gadolinium chelate that shortens proton relaxation times, so tissues where it leaks out of blood vessels, such as tumours with a disrupted blood-brain barrier or abnormal vessels, appear bright on MRI.
- Approvals: US 2011: MRI of the central nervous system; breast MRI to assess the presence and extent of malignant breast disease; MR angiography; cardiac MRI

## Sources

- Drugs@FDA Gadavist (NDA 201277): https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=201277
- DailyMed label: Gadavist: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bd28560f-de4d-4140-874e-31df823f4dbb
- Drugs@FDA Pixxoscan (ANDA 215957): https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215957
- WHO ATC index V08CA: paramagnetic contrast media: https://atcddd.fhi.no/atc_ddd_index/?code=V08CA&showdescription=no

## Connected records

- cancers: [Brain metastases (secondary brain tumours)](https://onco.cc/cancers/secondary-brain-tumours/), [Breast cancer (all types)](https://onco.cc/cancers/breast-cancer/), [Glioma & glioblastoma](https://onco.cc/cancers/glioblastoma/)
- technologies: [Breast MRI coils and abbreviated breast MRI](https://onco.cc/technologies/breast-mri-coils-abbreviated-mri/), [Gadolinium-based and other MRI contrast agents](https://onco.cc/technologies/gadolinium-based-contrast-agents/), [MRI](https://onco.cc/technologies/mri/)
- companies: [Bayer](https://onco.cc/companies/bayer/), [GE HealthCare](https://onco.cc/companies/ge-healthcare/)

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