Flutemetamol (18F)
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| Trade names | Vizamyl |
| AHFS/Drugs.com | Micromedex Detailed Consumer Information |
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| Routes of administration | Intravenous |
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| Formula | C14H1118FN2OS |
| Molar mass | 273.316 g·mol−1 |
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Flutemetamol (18F)(trade nameVizamyl,byGE Healthcare) is aPET scanningradiopharmaceuticalcontaining the radionuclidefluorine-18,used as a diagnostic tool forAlzheimer's disease.[2]
Adverse effects
[edit]Adverse effects of flutemetamol include headache,nausea,dizziness, flushing and increased blood pressure.[3]
Mechanism of action
[edit]After the substance is givenintravenously,it accumulates inbeta amyloidplaques in the patient's brain, which thus become visible via positron emission tomography (PET).[2]
Manufacturing and distribution
[edit]Flutemetamol (18F) can be produced within five to six hours. It then undergoes a quality check and is ready to be distributed immediately after. The product must be used within a certain time frame for maximum efficacy. Because of the limited time window, flutemetamol is not produced until an order has been placed.[4]
Flutemetamol is typically administeredintravenouslyin 1 to 10 mL doses.[5]Average costs for PET scans without insurance coverage are around $3,000. CurrentlyMedicaredoes not cover use of amyloid imaging agents except for in clinical trials.[6]Because of this, there is a low market for flutemetamol.
History
[edit]Flutemetamol was first approved for use in the US by theFood and Drug Administration(FDA) in 2013 for intravenous use.[7]
Clinical trials
[edit]Two clinical trials were conducted for flutemetamol (18F). The first compared PET scans of terminally ill patients with flutemetamol topost mortemstandard-of-truth assessments of cerebral corticalneuritic plaquedensity. The second trial assessed intra-reader reproducibility of PET scans using flutemetamol.[8]
Clinical trial 1
[edit]Of the 176 patients imaged in this trial had a median age was 82, with 57 of patients being female. The initial flutemetamol PET scan resulted in 43 positive and 25 negative results for cerebral cortisol amyloid status. 69 of the initial patients died within 13 months of the flutemetamol PET scan. The autopsy for 67 of those patients determined the global brain neuritic plaque density category. Of those 67 patients 41 were positive and 26 were negative.[7]These results correlate with the pre-mortem scan.
Clinical trial 2
[edit]The second clinical trial included 276 subjects with a median age of 72. The trial measured the effectiveness of an electronic training program for flutemetamol image interpretation using PET scans from trial 1 among other subjects with a variety of cognitive impairment. Final results met the pre-specified success rate with aFleiss' kappa statisticof 0.83.[7]
References
[edit]- ^"Vizamyl EPAR".European Medicines Agency.22 August 2014.Retrieved29 June2024.
- ^abSpreitzer H (18 August 2014). "Neue Wirkstoffe – Flutemetamol".Österreichische Apothekerzeitung(in German) (17/2014): 43.
- ^"FDA Press Release".FDA.Retrieved17 November2016.
- ^"Manufacturing and Distribution | Vizamyl (Flutemetamol F 18 Injection)".www.gevizamyl.com.Archived fromthe originalon 21 November 2016.Retrieved21 November2016.
- ^"Life Sciences Content Alert".www3.gehealthcare.co.uk.Archived fromthe originalon 26 February 2015.Retrieved21 November2016.
- ^"Alzheimer's Association"(PDF).Archived fromthe original(PDF)on 16 February 2017.Retrieved20 November2016.
- ^abc"GE Vizamyl"(PDF).gevizamyl.Archived fromthe original(PDF)on 16 February 2017.Retrieved20 November2016.
- ^"Efficacy and Safety | Vizamyl (Flutemetamol F 18 Injection)".www.gevizamyl.com.Archived fromthe originalon 21 November 2016.Retrieved20 November2016.
