Flutemetamol F-18

What is Flutemetamol F-18?

• Flutemetamol F-18 (Vizamyl) is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging.

What are the uses of this medicine?

This medicine is used for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's Disease (AD) and other causes of cognitive decline.

• A negative Vizamyl scan indicates sparse to no neuritic plaques, and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient's cognitive impairment is due to AD.
• A positive Vizamyl scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions, as well as older people with normal cognition.
• Vizamyl is an adjunct to other diagnostic evaluations.

Limitations of Use:

• A positive Vizamyl scan does not establish a diagnosis of AD or other cognitive disorder

Safety and effectiveness of Vizamyl have not been established for:

• Predicting development of dementia or other neurological condition
• Monitoring responses to therapies

How does this medicine work?

• Flutemetamol F 18 binds to β-amyloid plaques in the brain and the F-18 isotope produces a positron signal that is detected by a PET scanner.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• with a history of hypersensitivity reaction to Vizamyl, polysorbate 80, or any other inactive ingredient in Vizamyl.

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted with Vizamyl.

Is this medicine FDA approved?

• Initial U.S. Approval: 2013

How should this medicine be used?

Recommended Dosage:

• The recommended dose for Vizamyl is 185 megabecquerels (MBq) [5 millicuries (mCi)] in a maximum dose volume of 10 mL, administered as a single intravenous bolus within 40 seconds.
• The maximum mass dose is 20 micrograms.
• Follow the injection with an intravenous flush of 5 to 15 mL of 0.9% sterile sodium chloride injection.
• Obtain 10 to 20-minute PET images starting approximately 60 to 120 minutes after intravenous injection.

Administration

• Vizamyl is a radioactive drug and should be handled with safety measures to minimize radiation exposure during administration.
• Use waterproof gloves and effective shielding, including lead-glass syringe shields when handling and administering Vizamyl.
• To minimize radiation dose to the bladder, encourage patients to hydrate before and after Vizamyl administration in order to permit frequent voiding.
• Encourage patients to void before and after imaging with Vizamyl and frequently thereafter for 24 hours following Vizamyl administration.
• Use aseptic technique and radiation shielding to withdraw and administer Vizamyl solution.
• Calculate the necessary volume to administer based on calibration time and dose using a suitably calibrated instrument.
• Visually inspect Vizamyl for particulate matter and discoloration prior to administration. Do not administer Vizamyl if it contains particulate matter or is discolored .
• Do not dilute Vizamyl.
• Dispose of unused product in a safe manner in compliance with applicable regulations.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 150 MBq/mL (4.05 mCi/mL) at reference date and time in 30 mL multi-dose vials

This medicine is available in fallowing brand namesː

• Vizamyl

What side effects can this medication cause?

The most common side effects of this medicine include:

• flushing
• headache
• increased blood pressure
• nausea
• dizziness

What special precautions should I follow?

• Hypersensitivity reactions such as flushing and dyspnea have been observed within minutes following Vizamyl administration. Ask patients about prior reactions to Vizamyl. Observe for hypersensitivity signs and symptoms following Vizamyl administration. Have resuscitation equipment and trained personnel available at time of Vizamyl administration.
• Errors may occur while using Vizamyl PET images to estimate brain neuritic plaque density.
• Vizamyl, similar to other radiopharmaceuticals, contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure.

What to do in case of emergency/overdose?

• Overdose with Vizamyl has not been reported.

Management of overdosage:

• In case of overdose of radioactivity, hydration and frequent urination should be encouraged to minimize radiation exposure to the patient; care should be taken to avoid contamination from the radioactivity eliminated by the patient.
• It is unknown whether or not flutemetamol is dialyzable.

Can this medicine be used in pregnancy?

• 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.

Can this medicine be used in children?

• Vizamyl is not indicated for use in pediatric patients.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• Flutemetamol F-18

Inactive ingredients:

• Alcohol
• Sodium Chloride
• Polysorbate 80

Who manufactures and distributes this medicine?

• Packager: Medi-Physics, Inc. dba GE Healthcare

What should I know about storage and disposal of this medication?

Storage

• Store Vizamyl at 2° to 30°C (36° to 86°F). The product does not contain a preservative. Store Vizamyl within radiation shielding. Do not use Vizamyl after the expiry date and time stated on the label.

Handling

• Vizamyl must not be diluted. This preparation is for use by persons licensed by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.

• Dailymed label info on Flutemetamol F-18
• FDA Flutemetamol F-18

Flutemetamol F-18 Resources
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