{"entity":{"id":"f-18-florbetaben","kind":"drug","name":"Florbetaben F-18","aka":["Neuraceq"],"tldr":"A PET scan tracer that lights up amyloid plaques in the brain, helping doctors work out whether memory problems are due to Alzheimer's disease and whether the patient can have amyloid-lowering treatment.","summary":"Florbetaben F-18 (Neuraceq, originally Piramal, now Life Molecular Imaging/Lantheus) was FDA-approved in March 2014 and EMA-approved in February 2014, for PET imaging of the brain to estimate beta-amyloid neuritic plaque density in adults with cognitive impairment being evaluated for AD and other causes of cognitive decline. As with florbetapir and flutemetamol, the current US label has been updated to add selection of patients for amyloid beta-directed therapy as a second indication.\n\nThe recommended dose is 300 MBq (8.1 mCi) given as a slow intravenous bolus (6 seconds/mL) in up to 10 mL, maximum mass dose 30 micrograms; PET imaging in the US label starts 45 to 130 minutes post-injection (commonly around 90 minutes), and the EU posology allows 240-360 MBq with the target at 300 MBq. Effective dose from a 300 MBq administration is about 5.8 mSv.\n\nVisual interpretation looks for loss of the normal grey-white matter contrast from increased cortical tracer retention; florbetaben has its own validated linear conversion to the Centiloid scale, and the 2024 EMA/CHMP qualification opinion on the Centiloid measure discusses florbetaben-specific data showing that values above about 35 CL indicate established amyloid pathology while values below about 20 CL are compatible with a negative visual read, with 20-35 CL an ambiguous zone. Neuraceq sits in the same US clinical-use and Medicare-coverage landscape as the other amyloid tracers: appropriate for diagnostic work-up in uncertain cognitive impairment and for confirming eligibility for anti-amyloid antibody therapy per the 2025 SNMMI/Alzheimer's Association appropriate use criteria, with Medicare coverage now determined locally following the October 2023 retirement of the national coverage determination.","status":"approved","asOf":"2026-09-22","links":[{"label":"FDA label: Neuraceq (florbetaben F 18 injection)","url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/204677s041lbl.pdf"},{"label":"EMA EPAR: Neuraceq","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/neuraceq"},{"label":"EMA CHMP: qualification opinion for Centiloid measure of amyloid PET (25 June 2024)","url":"https://www.ema.europa.eu/system/files/documents/other/qualification-opinion-centiloid-measure-amyloid-pet-quantify-brain-amyloid-deposition-en.pdf"},{"label":"CMS: decision memo removing the amyloid PET national coverage determination (NCA-CAL 308)","url":"https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=308"}],"tags":["amyloid PET","diagnostic","neurology"],"related":["alzheimers-disease","f-18-florbetapir","f-18-flutemetamol","lantheus","f-18"],"indications":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Neuraceq","modality":"PET tracer","mechanism":"A fluorine-18 labelled stilbene derivative that binds fibrillar beta-amyloid plaques in cortical grey matter, giving a PET signal proportional to plaque density.","approvals":[{"region":"US","year":2014,"indication":"PET imaging of the brain to estimate beta-amyloid neuritic plaque density in adults with cognitive impairment being evaluated for AD and other causes of cognitive decline"},{"region":"EU","year":2014,"indication":"PET imaging of beta-amyloid neuritic plaque density in adults with cognitive impairment being evaluated for Alzheimer's disease and other causes of cognitive impairment"}],"mechanismSteps":[],"dosing":{"route":"Intravenous slow bolus (6 sec/mL)","schedule":"300 MBq (8.1 mCi) single dose in up to 10 mL; PET imaging roughly 45-130 minutes after injection (US label)","monitoring":"Visual read of cortical grey-white contrast; tracer-specific Centiloid conversion available for quantification","source":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/204677s041lbl.pdf"},"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/f-18-florbetaben/","neighbours":{"indication":[{"id":"alzheimers-disease","kind":"indication","name":"Alzheimer's disease","route":"/indications/alzheimers-disease/"}],"drug":[{"id":"f-18-florbetapir","kind":"drug","name":"Florbetapir F-18","route":"/drugs/f-18-florbetapir/"},{"id":"f-18-florquinitau","kind":"drug","name":"Florquinitau F-18","route":"/drugs/f-18-florquinitau/"},{"id":"f-18-flortaucipir","kind":"drug","name":"Flortaucipir F-18","route":"/drugs/f-18-flortaucipir/"},{"id":"f-18-flutemetamol","kind":"drug","name":"Flutemetamol F-18","route":"/drugs/f-18-flutemetamol/"}],"company":[{"id":"lantheus","kind":"company","name":"Lantheus","route":"/companies/lantheus/"}],"isotope":[{"id":"f-18","kind":"isotope","name":"Fluorine-18","route":"/isotopes/f-18/"}]}}