Flutemetamol: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: March 13, 2026🚩 Report this page

Flutemetamol

Active ingredient

Sold as Vizamyl

EU EMA

Drug class: -
Availability: See label
Markets covered: 1
Products on record: 1

Overview

Flutemetamol is an active pharmaceutical ingredient. The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
EU European Union	EMA	1	March 13, 2026

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised March 13, 2026[1]

This medicinal product is for diagnostic use only. VIZAMYL is a radiopharmaceutical medicinal product indicated for Positron Emission Tomography (PET) imaging of β-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive impairment.
VIZAMYL should be used in conjunction with a clinical evaluation. A negative scan indicates sparse or no plaques, which is not consistent with a diagnosis of AD. 1.

How to take

Sources & citations

[1]European Medicines Agency · EMEA/H/C/002557 · revised March 13, 2026

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

EUOfficial regulatory label· Adverse reactions· revised March 13, 2026[1]

Summary of the safety profile The overall safety profile of VIZAMYL is based on data from its administrations to 831 subjects. Tabulated list of adverse reactions The frequencies of adverse reactions are defined as follows: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. The following adverse reactions are listed in the Table 1 below: 9 Table 1 List of adverse reactions System Organ Class Common Uncommon Immune system disorders Anaphylactoid reaction Psychiatric disorders Anxiety Nervous system disorders Dizziness Headache Hypoaesthesia Hypotonia Dysgeusia Tremor Eye disorders Eye swelling Ear and labyrinth disorders Vertigo Cardiac disorders Palpitations Vascular disorders Flushing Pallor Respiratory, thoracic and mediastinal disorders Dyspnoea Hyperventilation Throat irritation Gastrointestinal disorders Nausea Vomiting Dyspepsia Abdominal discomfort Oral discomfort Skin and subcutaneous tissue disorders Facial hypoaesthesia Pruritus Rash Skin tightness Swelling face Musculoskeletal and connective tissue disorders Back pain Muscle tightness Musculoskeletal pain Reproductive system and breast disorders Erectile dysfunction General disorders and administration site conditions Chest discomfort Feeling hot Asthenia Fatigue Feeling abnormal Feeling cold Infusion site pain Oedema Pyrexia Investigations Increased blood pressure Blood glucose decreased Blood lactate dehydrogenase increased Neutrophil count increased Respiratory rate increased Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.
9 mSv when the maximal recommended activity of 185 MBq of flutemetamol (18F) is administered. These adverse events are expected to occur with low probability. 4). 10 Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

EUOfficial regulatory label· Warnings and precautions· revised March 13, 2026[1]

4 Interpretation of VIZAMYL images). Posology Adults 3 The recommended activity for an adult is 185 MBq of flutemetamol (18F) administered intravenously (as a bolus within approximately 40 seconds). The volume of the injection should be not less than 1 mL and not more than 10 mL.
Special populations Extensive dose-range and adjustment studies with the medicinal product in normal and special populations have not been performed. Elderly patients No dose adjustment is recommended based on age. Renal and hepatic impairment VIZAMYL has not been studied in patients with significant renal or hepatic impairment.
4). The pharmacokinetics of flutemetamol (18F) in patients with renal or hepatic impairment has not been characterised. Paediatric population There is no relevant use of VIZAMYL in the paediatric population. Method of administration VIZAMYL is for intravenous use.
The activity of flutemetamol (18F) has to be measured with a dose calibrator immediately prior to injection. 5 cm or less) minimises the potential for adsorption of the active substance to the catheter. VIZAMYL is for multidose use. It must not be diluted.
The dose is administered by intravenous bolus injection within approximately 40 seconds. 9%) solution for injection to ensure full delivery of the dose. The injection of flutemetamol (18F) must be intravenous in order to avoid irradiation as a result of local extravasation, as well as imaging artefacts.
Image acquisition VIZAMYL images should be acquired starting 90 minutes after injection, using a PET scanner in 3D mode with appropriate data corrections. Position the patient supine with the patient’s brain (including the cerebellum) within a single field of view.
The patient’s head should be tilted so that the anterior commissure-posterior commissure (ACPC) plane is at right angles to the bore-axis of the PET scanner with the head positioned in a suitable head support. Reducing head movement with tape or other flexible head restraints may be employed.
Iterative or filtered back projection reconstruction is recommended with a slice thickness of 2 to 4 mm, and an axial matrix size of 128 x 128 with pixel sizes of approximately 2 mm. Where a post- smoothing filter may be applied with a full width half maximum (FWHM) of not more than 5 mm, the filter FWHM should be chosen to optimize the signal-to-noise ratio while preserving the sharpness of the reconstructed image.

This is not medical advice. Consult a qualified healthcare professional.