{"entity":{"id":"gadobutrol","kind":"drug","name":"Gadobutrol","aka":["gadobutrol","Gadavist","Pixxoscan"],"tldr":"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.","status":"approved","asOf":"2026-11-04","links":[{"label":"Drugs@FDA Gadavist (NDA 201277)","url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=201277"},{"label":"DailyMed label: Gadavist","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bd28560f-de4d-4140-874e-31df823f4dbb"},{"label":"Drugs@FDA Pixxoscan (ANDA 215957)","url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215957"},{"label":"WHO ATC index V08CA: paramagnetic contrast media","url":"https://atcddd.fhi.no/atc_ddd_index/?code=V08CA&showdescription=no"}],"tags":["contrast-agents-gaps-2026-11","diagnostic"],"related":[],"cancers":["breast-cancer","glioblastoma","secondary-brain-tumours"],"sections":[],"technologies":["gadolinium-based-contrast-agents","mri","breast-mri-coils-abbreviated-mri"],"targets":[],"drugs":[],"companies":["bayer","ge-healthcare"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo contrast agent gap fill (Drugs@FDA, FDA labels, DailyMed, EMA register, WHO ATC index)","editedOn":"2026-11-04"},"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":[{"region":"US","year":2011,"indication":"MRI of the central nervous system; breast MRI to assess the presence and extent of malignant breast disease; MR angiography; cardiac MRI","note":"NDA 201277; Bayer"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/gadobutrol/","neighbours":{"cancer":[{"id":"secondary-brain-tumours","kind":"cancer","name":"Brain metastases (secondary brain tumours)","route":"/cancers/secondary-brain-tumours/"},{"id":"breast-cancer","kind":"cancer","name":"Breast cancer (all types)","route":"/cancers/breast-cancer/"},{"id":"glioblastoma","kind":"cancer","name":"Glioma & glioblastoma","route":"/cancers/glioblastoma/"}],"technology":[{"id":"breast-mri-coils-abbreviated-mri","kind":"technology","name":"Breast MRI coils and abbreviated breast MRI","route":"/technologies/breast-mri-coils-abbreviated-mri/"},{"id":"gadolinium-based-contrast-agents","kind":"technology","name":"Gadolinium-based and other MRI contrast agents","route":"/technologies/gadolinium-based-contrast-agents/"},{"id":"mri","kind":"technology","name":"MRI","route":"/technologies/mri/"}],"company":[{"id":"bayer","kind":"company","name":"Bayer","route":"/companies/bayer/"},{"id":"ge-healthcare","kind":"company","name":"GE HealthCare","route":"/companies/ge-healthcare/"}]}}