Florbetapir: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: May 29, 2026🚩 Report this page

Florbetapir

Active ingredient

Sold as Amyvid

GB MHRAEU EMA

Drug class: -
Availability: See label
Markets covered: 2
Products on record: 3

Overview

Florbetapir 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
GB United Kingdom	MHRA	2	May 29, 2026
EU European Union	EMA	1	January 16, 2026

GBUnited Kingdom· MHRA

2 products

Uses

GBOfficial regulatory label· revised May 29, 2026[1]

This medicinal product is for diagnostic use only. Amyvid is a radiopharmaceutical indicated for use with Positron Emission Tomography (PET). Diagnosis 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.
Amyvid 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. Monitoring Imaging of β-amyloid neuritic plaque density in the brains of adult patients receiving amyloid-targeting therapy.

How to take

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised January 16, 2026[2]

This medicinal product is for diagnostic use only. Amyvid is a radiopharmaceutical 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.
Amyvid 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]MHRA (UK) · PLGB148950232 · revised May 29, 2026
[2]European Medicines Agency · EMEA/H/C/002422 · revised January 16, 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

GBOfficial regulatory label· Adverse reactions· revised May 29, 2026[1]

Summary of the safety profile The safety profile of Amyvid is based on its administrations to 26979 subjects in clinical trials. Tabulated list of adverse reactions Frequencies are defined as 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); not known (cannot be estimated from the available data).
System organ class Uncommon Rare Nervous system disorders Headache Dysgeusia Vascular disorders Flushing Gastrointestinal disorders Nausea Skin and subcutaneous tissue disorders Pruritus Urticaria General disorders and administration site conditions Injection site reactiona Infusion site rash aInjection site reaction includes injection site bruising, injection site discomfort, injection site erythema, injection site extravasation, injection site haemorrhage, injection site irritation, injection site paraesthesia, injection site pruritus, injection site pain, infusion site bruising, infusion site extravasation, infusion site reaction, infusion site haematoma, and infusion site pain.
Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. As the effective dose is 7 mSv when the recommended activity of 370 MBq of florbetapir (18F) is administered, these adverse reactions are expected to occur with low probability.
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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

GBOfficial regulatory label· Warnings and precautions· revised May 29, 2026[1]

4. Image interpretation). Posology The recommended activity for an adult weighing 70 kg is 370 MBq florbetapir (18F). The volume of the injection should not be less than 1 mL and not exceed 10 mL. Special populations Elderly No dose adjustment is recommended based on age.
4). Extensive dose-range and adjustment studies with the medicinal product in normal and special populations have not been performed. The pharmacokinetics of florbetapir (18F) in patients with renal or hepatic impairment have not been characterised.
Paediatric population There is no relevant use of Amyvid in the paediatric population. Method of administration Amyvid is for intravenous use and multidose use. The activity of florbetapir (18F) has to be measured with an activimeter (dose calibrator) immediately prior to injection.
9%) solution for injection to ensure full delivery of the dose. Injection of florbetapir (18F) through a short intravenous catheter (approximately 4 cm or less) minimises the potential for adsorption of the active substance to the catheter.
The injection of florbetapir (18F) must be intravenous in order to avoid irradiation as a result of local extravasation, as well as imaging artefacts. Image acquisition A 10 minute PET image should be acquired starting approximately 30 to 50 minutes after intravenous injection of Amyvid.
Patients should be supine with the head positioned to centre the brain, including the cerebellum, in the PET scanner field of view. Reducing head movement with tape or other flexible head restraints may be employed. 0 mm. 1. 4 Special warnings and precautions for use Limitations of use A positive scan does not independently establish a diagnosis of AD or other cognitive disorder since neuritic plaque deposition in grey matter may be present in asymptomatic elderly and some neurodegenerative dementias (Alzheimer’s disease, Lewy body dementia, Parkinson’s disease dementia).
1. 1). Some scans may be difficult to interpret due to image noise, atrophy with a thinned cortical ribbon, or image blur, which could lead to interpretation errors. For cases in which there is uncertainty about the location of grey matter and of the grey/white matter border on the PET scan, and a co-registered recent CT or MR image is available, the interpreter should examine the fused PET-CT or PET-MR image to clarify the relationship of the PET radioactivity and the grey matter anatomy.
2). Examination of sagittal images and co-registered CT or MR images could help to distinguish occipital bone from occipital grey matter. Individual benefit/risk justification For each patient, the radiation exposure must be justifiable by the likely benefit.
The activity administered should, in every case, be as low as reasonably achievable to obtain the required diagnostic information. Renal impairment and hepatic impairment Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure is possible.

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

Side effects & warnings

EUOfficial regulatory label· Adverse reactions· revised January 16, 2026[2]

Summary of the safety profile The safety profile of Amyvid is based on its administrations to 2,105 subjects in clinical trials. Tabulated list of adverse reactions Frequencies are defined as 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); not known (cannot be estimated from the available data).
While they may in reality occur at lower frequencies than indicated below, the size of the source database did not allow for the assignment of frequency categories lower than the category “uncommon” (≥1/1,000 to <1/100). System organ class Common Uncommon Nervous system disorders Headache Dysgeusia Vascular disorders Flushing Gastrointestinal disorders Nausea Skin and subcutaneous tissue disorders Pruritus Urticaria General disorders and administration site conditions Injection site reactiona Infusion site rash aInjection site reaction includes injection site haemorrhage, injection site irritation, and injection site pain 8 Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.
As the effective dose is 7 mSv when the recommended activity of 370 MBq of florbetapir (18F) is administered, these adverse reactions are expected to occur with low probability. 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 January 16, 2026[2]

4. Image interpretation). Posology The recommended activity for an adult weighing 70 kg is 370 MBq florbetapir (18F). The volume of the injection should not be less than 1 mL and not exceed 10 mL. Special populations Elderly No dose adjustment is recommended based on age.
4). Extensive dose-range and adjustment studies with the medicinal product in normal and special populations have not been performed. The pharmacokinetics of florbetapir (18F) in patients with renal or hepatic impairment have not been characterised.
Paediatric population There is no relevant use of Amyvid in the paediatric population. Method of administration Amyvid is for intravenous use and multidose use. The activity of florbetapir (18F) has to be measured with an activimeter (dose calibrator) immediately prior to injection.
9%) solution for injection to ensure full delivery of the dose. Injection of florbetapir (18F) through a short intravenous catheter (approximately 4 cm or less) minimises the potential for adsorption of the active substance to the catheter.
The injection of florbetapir (18F) must be intravenous in order to avoid irradiation as a result of local extravasation, as well as imaging artefacts. Image acquisition A 10 minute PET image should be acquired starting approximately 30 to 50 minutes after intravenous injection of Amyvid.
Patients should be supine with the head positioned to centre the brain, including the cerebellum, in the PET scanner field of view. Reducing head movement with tape or other flexible head restraints may be employed. 0 mm. 1. 4 Special warnings and precautions for use Limitations of use A positive scan does not independently establish a diagnosis of AD or other cognitive disorder since neuritic plaque deposition in grey matter may be present in asymptomatic elderly and some neurodegenerative dementias (Alzheimer’s disease, Lewy body dementia, Parkinson’s disease dementia).
1. 1). Some scans may be difficult to interpret due to image noise, atrophy with a thinned cortical ribbon, or image blur, which could lead to interpretation errors. For cases in which there is uncertainty about the location of grey matter and of the grey/white matter border on the PET scan, and a co-registered recent CT or MR image is available, the interpreter should examine the fused PET-CT or PET-MR image to clarify the relationship of the PET radioactivity and the grey matter anatomy.
2). Examination of sagittal images and co-registered CT or MR images could help to distinguish occipital bone from occipital grey matter. Individual benefit/risk justification For each patient, the radiation exposure must be justifiable by the likely benefit.
The activity administered should, in every case, be as low as reasonably achievable to obtain the required diagnostic information. Renal impairment and hepatic impairment Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure is possible.

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