Flutemetamol F-18

What Flutemetamol F-18 is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

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 …

— FDA label: Vizamyl, GE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare), effective April 6, 2026. Read the full label on DailyMed →

Label quoted: the one for the most common form (solution, intravenous), Vizamyl, GE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare); it covers 1 product in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

Flutemetamol F-18 side effects

Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.

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.

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(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. Table 2: Adverse Reactions Reported in ≥ 1% of Adult Subjects Who Received VIZAMYL in Clinical Trials Adverse Reaction VIZAMYL N=761 % Flushing 2 Increased blood pressure 2 Headache 1 Nausea 1 Dizziness 1 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of VIZAMYL. 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. Immune system disorders: anaphylactic reactions

— FDA label: Vizamyl, GE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare), effective April 6, 2026. Read the full label on DailyMed →

Flutemetamol F-18 dosage

Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.

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.

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(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. Patient Preparation Instruct patients to hydrate before and after VIZAMYL administration and to void frequently following VIZAMYL administration to reduce radiation exposure [see Warnings and Precautions (5.3)]. Administration Use aseptic technique and radiation shielding to withdraw and administer VIZAMYL. Visually inspect VIZAMYL for particulate matter and discoloration prior to administration. Do not use VIZAMYL if it contains particulate matter or if it is discolored. Do not dilute VIZAMYL. Calculate the necessary volume to administer based on calibration time and required dose. Measure the activity of VIZAMYL with a dose calibrator immediately prior to administration to the patient. Dispose of unused product in a safe manner in compliance with applicable regulations. 2.3 Image Acquisition Instructions Position the patient supine with the head positioned to center the brain, including the cerebellum, within a single field of view. The patient's head should be tilted so that the anterior commissure-posterior commissure (AC-PC) plane is at right angles to the bore-axis of the PET scanner, with the head positioned in a suitable head support. Tape or other flexible head restraints may be employed to reduce head movement. Acquire 10-minute to 20-minute PET images starting 60 minutes to 120 minutes after VIZAMYL administration using a PET scanner in 3-D mode with appropriate data corrections. Iterative or filtered back-projection reconstruction is recommended with a slice thickness of 2 mm to 4 mm, and matrix size of 128 × 128 with pixel sizes of approximately 2 mm.

— FDA label: Vizamyl, GE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare), effective April 6, 2026. This is part of the section. Read the full label on DailyMed →

Flutemetamol F-18 in pregnancy

Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a 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.

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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.

— FDA label: Vizamyl, GE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare), effective April 6, 2026. Read the full label on DailyMed →

When Flutemetamol F-18 should not be used

Quoted from the “Contraindications” section of the FDA-approved label.

VIZAMYL is contraindicated in patients with a history of hypersensitivity reaction to VIZAMYL or polysorbate 80 [see Warnings and Precautions (5.1)]. Known hypersensitivity to VIZAMYL or polysorbate 80 (4)

— FDA label: Vizamyl, GE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare), effective April 6, 2026. Read the full label on DailyMed →

Flutemetamol F-18 overdose

Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).

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.

— FDA label: Vizamyl, GE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare), effective April 6, 2026. Read the full label on DailyMed →

Forms and how it is given

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

• GE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare)1 product

FDA approval history

• NDA: New Drug Application: how a new (usually brand-name) medicine is approved.

Shortage status

The FDA drug shortage list does not show these products.

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Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

Next steps

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Sources

1. FDA-approved label on DailyMed (National Library of Medicine) — Vizamyl, GE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare), effective April 6, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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