Flutemetamol

Flutemetamol F 18 binds to amyloid beta plaques in the brain and the F 18 isotope produces a positron signal that is detected by a PET scanner. In in vitro binding studies using postmortem human brain homogenates containing fibrillar amyloid beta, the dissociation constant (Kd) for flutemetamol was 6.7 nM.

• VIZAMYL 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 information of the therapeutic products VIZAMYL is a radioactive diagnostic drug 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 information of the therapeutic products ( 1 )ICD-10: G30.9

• VIZAMYL is contraindicated in patients with a history of hypersensitivity reaction to VIZAMYL or polysorbate 80 [see Warnings and Precautions (5.1) ] .contraindicated

The recommended amount of radioactivity is 185 MBq (5 mCi) administered as a single intravenous bolus within 40 seconds in a total volume of up to 10 mL. ( 2.2 ) Follow injection with an intravenous flush of 5 mL to 15 mL of 0.9% sodium chloride injection. ( 2.2 ) Obtain 10-minute to 20-minute PET images starting approximately 60 minutes to 120 minutes after drug administration. ( 2.3 ) See full prescribing information for image interpretation and radiation dosimetry. ( 2.4 , 2.5 , 2.6 ) 2.1 Radiation Safety - Drug Handling Handle VIZAMYL with appropriate safety measures to minimize radiation exposure during administration [see Warnings and Precautions (5.3) ] . Use waterproof gloves and effective radiation shielding, including lead-glass syringe shields when handling and administering VIZAMYL. Radiopharmaceuticals, including VIZAMYL, should be used by or under the control of healthcare providers who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides. 2.2 Recommended Dosage and Administration Instructions Recommended Dosage The recommended amount of activity of VIZAMYL is 185 MBq (5 mCi) in a total volume of up to 10 mL, administered as a single intravenous bolus within 40 seconds. The maximum mass dose is 20 mcg. Follow the injection with an intravenous flush of 5 mL to 15 mL of 0.9% sodium chloride injection.

Anaphylaxis and Other Serious Hypersensitivity Reactions: Always have emergency resuscitation equipment and trained personnel available at the time of VIZAMYL administration. ( 5.1 ) Risk of Image Misinterpretation and Other Errors: Image interpretation errors have been observed. ( 5.2 ) Radiation Risk: VIZAMYL contributes to a patient's long-term cumulative radiation exposure. 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. ( 2.1 , 2.2 , 5.3 ) 5.1 Anaphylaxis and Other Serious Hypersensitivity Reactions Serious hypersensitivity reactions including anaphylaxis, presenting with flushing, dyspnea, and hypotension, have been observed within minutes following VIZAMYL administration. These reactions may occur in patients with no history of exposure to VIZAMYL [see Adverse Reactions (6.1 , 6.2) ] . 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 [see Contraindications (4) ] . 5.2 Risk of Image Misinterpretation and Other Errors Errors may occur in the estimation of amyloid beta neuritic plaque density during VIZAMYL image interpretation [see Clinical Studies (14) ] .

The following clinically significant adverse reaction is described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Most common adverse reactions (incidence ≥ 1%) were flushing, increased blood pressure, headache, nausea, and dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 1-800-654-0118 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of VIZAMYL was evaluated in 761 adult subjects who received VIZAMYL by intravenous injection in clinical trials. Most subjects (70%) received a dose of 185 MBq (5 mCi). The subjects had a mean age of 62 years (range 18 years to 93 years); 45% of the subjects were male and 91% were White. A serious hypersensitivity reaction characterized by flushing, dyspnea, and chest pressure was reported within minutes following VIZAMYL administration in one subject who recovered with treatment. Adverse reactions reported in ≥ 1% of subjects from the clinical trials are shown in Table 2.

Lactation: Temporarily discontinue breastfeeding. A lactating woman should pump and discard breast milk for 24 hours after VIZAMYL administration. ( 8.2 ) 8.1 Pregnancy Risk Summary There are no available data on VIZAMYL use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with flutemetamol F 18 to evaluate its effect on female reproduction and embryo-fetal development. 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. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Metabolism

Following intravenous administration of 185 MBq (5 mCi) of VIZAMYL in healthy subjects, flutemetamol F 18 plasma concentrations declined by approximately 75% in the first 20 minutes post-injection, and by approximately 90% in the first 180 minutes. The F 18 in circulation during the 30-minute to 120-minute imaging window was principally in the form of flutemetamol metabolites.

The major risks of overdose relate predominantly to increased radiation exposure, with long-term risks 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 flutemetamol is dialyzable.

• Oct 25, 2013NDANDA203137Ge Healthcare

1. 1Flushing19949%
2. 2Dyspnoea11328%
3. 3Back Pain9223%
4. 4Nausea7118%
5. 5Dizziness6917%
6. 6Chest Discomfort5213%
7. 7Headache379.2%
8. 8Chest Pain368.9%
9. 9Feeling Hot297.2%
10. 10Cough286.9%
11. 11Erythema276.7%
12. 12Hot Flush266.5%
13. 13Hyperhidrosis246.0%
14. 14Muscle Spasms235.7%
15. 15Blood Pressure Increased184.5%

The 10 most recently updated of 36 ClinicalTrials.gov registrations naming Flutemetamol as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• The Role of Large Artery Plaque Imaging Features in Predicting Inflammation and Cognition
  Active not recruiting · Phase 2 · Interventional · 45 enrolled · Scott Mcnally
  NCT03068442updated 2026-05-13
• Ultralow Dose PET Imaging of 18F-Florbetapir, 18F-Flutemetamol
  Recruiting · Phase 2 · Interventional · 200 enrolled · Akiva Mintz
  NCT07012993updated 2026-04-13
• The Swedish BioFINDER - Preclinical AD Study
  Recruiting · Observational · 800 enrolled · Skane University Hospital
  NCT06121544updated 2026-04-06
• The Swedish BioFINDER 2 Study
  Recruiting · Interventional · 2,950 enrolled · Skane University Hospital
  NCT03174938updated 2026-04-06
• Generation of Synthetic [18F]FDG PET From Early-Phase Amyloid PET in Alzheimer's Disease
  Not yet recruiting · Observational · 35 enrolled · IRCCS San Raffaele
  NCT07431255updated 2026-02-24
• Head-to-Head Harmonization of Tau Tracers in Alzheimer's Disease
  Active not recruiting · Phase 1 · Interventional · 822 enrolled · Tharick Pascoal
  NCT05361382updated 2025-10-29
• Parametric Cardiac 18F-flutemetamol PET Imaging in ATTR Cardiomyopathy
  Completed · Phase 1 · Interventional · 12 enrolled · Yale University
  NCT05374564updated 2025-08-03
• Amyloid-β Clearance Mechanisms in Alzheimer's Disease
  Recruiting · Observational · 60 enrolled · Ludwig-Maximilians - University of Munich
  NCT05059158updated 2025-07-04
• Activity of Cerebral Networks, Amyloid and Microglia in Aging and Alzheimer's Disease
  Completed · Observational · 140 enrolled · Ludwig-Maximilians - University of Munich
  NCT06224920updated 2025-07-04
• Study of the Indications for Amyloid Positon Emission Tomography (PET) Scans and Their Usefulness for Patients With Suspected Alzheimer's Disease (AD)
  Completed · Observational · 160 enrolled · Central Hospital, Nancy, France
  NCT06467981updated 2025-06-05

Frequently asked questions

How does Flutemetamol work?

Flutemetamol F 18 binds to amyloid beta plaques in the brain and the F 18 isotope produces a positron signal that is detected by a PET scanner. In in vitro binding studies using postmortem human brain homogenates containing fibrillar amyloid beta, the dissociation constant (Kd) for flutemetamol was 6.7 nM.

What is Flutemetamol used for?

According to FDA labeling, Flutemetamol carries indications including: VIZAMYL 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 information of the therapeutic products VIZAMYL is a radioactive diagnostic drug 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 information of the therapeutic products ( 1 ). This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What are the contraindications for Flutemetamol?

Flutemetamol labeling lists contraindications including: VIZAMYL is contraindicated in patients with a history of hypersensitivity reaction to VIZAMYL or polysorbate 80 [see Warnings and Precautions (5.1) ] .. Always consult the full prescribing information and a clinician.