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From advanced information to recent guidelines and standards, our resources can help you understand how using Vizamyl can improve your amyloid PET workflow.
Enhance clarity, even in challenging cases¹˒²
With the advent of anti-amyloid therapies and the increasing demand for for earlier amyloid PET imaging, it’s more important than ever to assess amyloid burden clearly and consistently for confident diagnosis and treatment planning.
Vizamyl's unique imaging and interpretation features may help support you in reducing equivocal scans and delivering confident results.¹
Vizamyl was designed for confident clinical interpretation
Discover the imaging, interpretation, and quantification capabilities that help support confident amyloid PET assessment.
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Five read regions
The only FDA-approved tracer with five read regions, including the striatum, for assistance especially in cases of atrophy. The five read regions can be viewed in three imaging planes, where one positive region confirms a positive scan.¹
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Full-color imaging
The only FDA-approved tracer with full-color image interpretation, including at least five distinct colors. Extending beyond traditional black and white may enhance assessment.1,5,6
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Color scale is anchored to the pons
Vizamyl image interpretation leverages a standardized color scale anchored to the pons—a region minimally affected by amyloid—for a stable reference point, enabling reliable, consistent assessment across patients and over time.¹
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Precise, accurate quantification
Objective measurement, alongside a clear visual read, supporting a confident path forward.1,2,7,8
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Efficient workflows
Minimal uptake in non-cerebral regions, such as the salivary glands, reduces workflow adjustments and facilitates consistent results.⁴
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Supporting your patients and practice with what’s next
Choose Vizamyl to help clinicians and patients get the answers they need.
References
- Vizamyl Prescribing Information. GE HealthCare; 2025.
- Collij LE, Bischof GN, Altomare D, et al. Quantification supports amyloid PET visual assessment of challenging cases: results from the AMYPAD diagnostic and patient management study. J Nucl Med. 2025;66(1):110–116. doi:10.2967/jnumed.124.268119
- Jagust WJ, Mattay VS, Krainak DM, et al. Quantitative brain amyloid PET. J Nucl Med. 2024;65(5):670–678. doi:10.2967/jnumed.123.265766
- Schmidt ME, Chiao P, Klein G, et al. The influence of biological and technical factors on quantitative analysis of amyloid PET: points to consider and recommendations for controlling variability in longitudinal data. Alzheimers Dement. 2015;11(9):1050–1068. doi:10.1016/j.jalz.2014.09.004
- Poyser CA, Tickle A. Exploring the experience of the disclosure of a dementia diagnosis from a clinician, patient and carer perspective: a systematic review and meta-ethnographic synthesis. Aging Ment Health. 2019;23(12):1605-1615.
- Wollney EN, Armstrong MJ, Bedenfield N, et al. Barriers and best practices in disclosing a dementia diagnosis: a clinician interview study. Health Serv Insights. 2022;15:11786329221141829.
- Pemberton HG, Collij LE, Heeman F, et al. Quantification of amyloid PET for future clinical use: a state-of-the-art review. Eur J Nucl Med Mol Imaging. 2022;49(10):3508–3528. doi: 10.1007/s00259-022-05784-y
- Myburgh PJ, Sai KKS. Two decades of [11C]PiB synthesis, 2003–2023: a review. Am J Nucl Med Mol Imaging. 2024;14(1):48–62. doi: 10.62347/ADSK6584
PRODUCT INDICATIONS AND USE
VIZAMYL™ (flutemetamol F 18 injection) is indicated for positron-emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for:
- Evaluation of Alzheimer’s disease (AD) and other causes of cognitive decline
- Selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing of information of the therapeutic products.
CONTRAINDICATIONS
- VIZAMYL is contraindicated in patients with a history of hypersensitivity reaction to VIZAMYL or polysorbate 80.
WARNINGS AND PRECAUTIONS
- Anaphylaxis and Other Serious Hypersensitivity Reactions: Serious hypersensitivity reactions including anaphylaxis, presenting with flushing, dyspnea, and hypotension have been observed within minutes following administration and may occur in patients with no history of exposure to VIZAMYL. Obtain a history of allergy or hypersensitivity reactions. Always have resuscitation equipment and trained personnel immediately available at the time of VIZAMYL administration. If a hypersensitivity reaction is suspected, immediately discontinue the injection and initiate appropriate therapy. VIZAMYL is contraindicated in patients with a history of hypersensitivity to VIZAMYL or polysorbate 80.
- Risk of Image Misinterpretation and Other Errors: Errors may occur in the estimation of amyloid beta neuritic plaque density during VIZAMYL image interpretation. The use of clinical information in the interpretation of VIZAMYL images has not been evaluation and may lead to an inaccurate assessment. Extensive brain atrophy and motion artifacts that distort the image may limit the ability to distinguish gray and white matter on a VIZAMYL scan. Perform image interpretation independently of the patient’s clinical information. For cases where there is uncertainty as to the location of cortical signal, use co-registered anatomical imaging to improve localization of signal or examine the striatum for VIZAMYL signal as it is less affected by atrophy.
- Radiation Risk: VIZAMYL contributes to a patient’s long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe drug handling to protect patients and health care providers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration.
ADVERSE REACTIONS
- The most commonly reported adverse reactions in clinical trials were flushing (2 %), increased blood pressure (2 %), headache (1 %), nausea and dizziness (1 %). Postmarketing experience included anaphylactic reactions. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
USE IN SPECIFIC POPULATIONS
- Pregnancy: There are no available data on VIZAMYL in pregnant woman to evaluate drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. All radiopharmaceuticals, including VIZAMYL, have the potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiation dose. If considering VIZAMYL administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from the drug and the gestational timing of exposure.
- Lactation: There are no data on the presence of flutemetamol F 18 or metabolites in human milk or its effects on the breastfed infant or milk production. Exposure of VIZAMYL to a breastfed infant can be minimized by temporary discontinuation of breastfeeding. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VIZAMYL and any potential adverse effects on the breastfed child from VIZAMYL or from the underlying maternal condition.
- Pediatric Use: The safety and effectiveness of VIZAMYL have not been established pediatric patients.
- Geriatric Use: No overall differences in safety or effectiveness were observed between subjects 65 years of age and older and younger adult subjects.
OVERDOSAGE
- The major risks of overdosage relate predominantly to increased radiation exposure, with long-term risk for neoplasia. In the event of administration of a radiation overdose with VIZAMYL, hydration and frequent urination should be encouraged to minimize radiation exposure to the subject. It is unknown whether or not the flutemetamol is dialyzable.
Prior to VIZAMYL administration, please read the full Prescribing Information at gehealthcare.com/Vizamyl-PI for additional Important Safety Information.
To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 800 654 0118 (option 2 then option 1) or by email at GPV.drugsafety@gehealthcare.com or FDA at 800 FDA 1088 or www.fda.gov/medwatch
IMPORTANT SAFETY INFORMATION
PRODUCT INDICATIONS AND USE
VIZAMYL™ (flutemetamol F 18 injection) is indicated for positron-emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for:
- Evaluation of Alzheimer’s disease (AD) and other causes of cognitive decline
- Selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing of information of the therapeutic products.
CONTRAINDICATIONS
- VIZAMYL is contraindicated in patients with a history of hypersensitivity reaction to VIZAMYL or polysorbate 80.
WARNINGS AND PRECAUTIONS
- Anaphylaxis and Other Serious Hypersensitivity Reactions: Serious hypersensitivity reactions including anaphylaxis, presenting with flushing, dyspnea, and hypotension have been observed within minutes following administration and may occur in patients with no history of exposure to VIZAMYL. Obtain a history of allergy or hypersensitivity reactions. Always have resuscitation equipment and trained personnel immediately available at the time of VIZAMYL administration. If a hypersensitivity reaction is suspected, immediately discontinue the injection and initiate appropriate therapy. VIZAMYL is contraindicated in patients with a history of hypersensitivity to VIZAMYL or polysorbate 80.
- Risk of Image Misinterpretation and Other Errors: Errors may occur in the estimation of amyloid beta neuritic plaque density during VIZAMYL image interpretation. The use of clinical information in the interpretation of VIZAMYL images has not been evaluation and may lead to an inaccurate assessment. Extensive brain atrophy and motion artifacts that distort the image may limit the ability to distinguish gray and white matter on a VIZAMYL scan. Perform image interpretation independently of the patient’s clinical information. For cases where there is uncertainty as to the location of cortical signal, use co-registered anatomical imaging to improve localization of signal or examine the striatum for VIZAMYL signal as it is less affected by atrophy.
- Radiation Risk: VIZAMYL contributes to a patient’s long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe drug handling to protect patients and health care providers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration.
ADVERSE REACTIONS
- The most commonly reported adverse reactions in clinical trials were flushing (2 %), increased blood pressure (2 %), headache (1 %), nausea and dizziness (1 %). Postmarketing experience included anaphylactic reactions. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
USE IN SPECIFIC POPULATIONS
- Pregnancy: There are no available data on VIZAMYL in pregnant woman to evaluate drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. All radiopharmaceuticals, including VIZAMYL, have the potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiation dose. If considering VIZAMYL administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from the drug and the gestational timing of exposure.
- Lactation: There are no data on the presence of flutemetamol F 18 or metabolites in human milk or its effects on the breastfed infant or milk production. Exposure of VIZAMYL to a breastfed infant can be minimized by temporary discontinuation of breastfeeding. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VIZAMYL and any potential adverse effects on the breastfed child from VIZAMYL or from the underlying maternal condition.
- Pediatric Use: The safety and effectiveness of VIZAMYL have not been established pediatric patients.
- Geriatric Use: No overall differences in safety or effectiveness were observed between subjects 65 years of age and older and younger adult subjects.
OVERDOSAGE
- The major risks of overdosage relate predominantly to increased radiation exposure, with long-term risk for neoplasia. In the event of administration of a radiation overdose with VIZAMYL, hydration and frequent urination should be encouraged to minimize radiation exposure to the subject. It is unknown whether or not the flutemetamol is dialyzable.
Prior to VIZAMYL administration, please read the full Prescribing Information at gehealthcare.com/Vizamyl-PI for additional Important Safety Information.
To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 800 654 0118 (option 2 then option 1) or by email at GPV.drugsafety@gehealthcare.com or FDA at 800 FDA 1088 or www.fda.gov/medwatch
JB14593US September 2026