Florbetapir (18F)

What is Florbetapir f 18?

• Florbetapir f 18 (Amyvid) is a radioactive diagnostic agent for Positron Emission Tomography (PET) imaging of the brain.

What are the uses of this medicine?

• Amyvid is indicated 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.
• Amyvid is an adjunct to other diagnostic evaluations.

• A negative Amyvid 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 Amyvid scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid 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.

How does this medicine work?

• Florbetapir F 18 binds to β-amyloid plaques and the F 18 isotope produces a positron signal that is detected by a PET scanner.
• The binding of florbetapir F 18 to β-amyloid aggregates was demonstrated.

Who Should Not Use this medicine ?

Limitations of Use:

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

Safety and effectiveness of Amyvid have not been established for:

• Predicting development of dementia or other neurologic condition;
• Monitoring responses to therapies.

What drug interactions can this medicine cause?

• Drug-drug interaction studies have not been performed with Amyvid.

Is this medicine FDA approved?

• Initial U.S. Approval: 2012

How should this medicine be used?

Recommended dosage:

• The recommended dose for Amyvid is 370 MBq (10 mCi), maximum 50 μg mass dose, administered as a single intravenous bolus in a total volume of 10 mL or less.
• Obtain 10-minute PET images starting approximately 30 to 50 minutes after intravenous injection.
• Follow the injection with an intravenous flush of 0.9% sterile sodium chloride.

Administration:

• Inspect the radiopharmaceutical dose solution prior to administration and do not use it if it contains particulate matter or is discolored.
• Use aseptic technique and radiation shielding to withdraw Amyvid solution.
• Assay the dose in a suitable dose calibrator prior to administration.
• Inject Amyvid through a short intravenous catheter (approximately 1.5 inches or less) to minimize the potential for adsorption of the drug to the catheter. Portions of the Amyvid dose may adhere to longer catheters.

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

This medicine is available in fallowing doasage form:

• As 30 mL or 50 mL multidose vial containing a clear, colorless injectable solution at a strength of 500-1900 MBq/mL (13.5-51 mCi/mL) florbetapir F 18 at End of Synthesis (EOS)

This medicine is available in fallowing brand namesː

• Amyvid

What side effects can this medication cause?

The most common side effects of this medicine include:

• musculoskeletal pain
• blood pressure increased
• fatigue
• nausea
• injection site reaction

What special precautions should I follow?

• Image interpretation errors (especially false negatives) have been observed. Amyvid scan results are indicative of the brain neuritic amyloid plaque content only at the time of image acquisition and a negative scan result does not preclude the development of brain amyloid in the future.
• Amyvid, similar to all radiopharmaceuticals, contributes to a patient's long-term cumulative radiation exposure. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no available data on Amyvid 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?

• Amyvid is not indicated for use in pediatric patients.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• FLORBETAPIR F-18

Inactive ingredients:

• Sodium Ascorbate
• Alcohol
• Sodium Chloride

Who manufactures and distributes this medicine?

• Manufactured by PETNET Solutions, Inc. Knoxville, TN 37932 for Avid Radiopharmaceuticals, a wholly-owned subsidiary of Eli Lilly and Company, Philadelphia, PA

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

• Store Amyvid at 25ºC (77°F); excursions permitted to 15ºC to 30ºC (59°F to 86°F).
• The product does not contain a preservative.
• Store Amyvid within the original container or equivalent radiation shielding.
• Amyvid must not be diluted.

• Dailymed label info on Florbetapir (18F)
• FDA Florbetapir (18F)

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