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florbetapir F 18 (Rx)Brand and Other Names:AMYViD

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

IV injection

  • 0.1-19mcg/mL (florbetapir) and 13.5-51mCi/mL (florbetapir F 18)
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Beta-Amyloid Plaque Estimation

Radioactive, adjunctive diagnostic agent for PET brain imaging to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer Disease (AD) and other causes of cognitive decline

A negative scan indicates sparse to no neuritic plaques, and is inconsistent with a neuropathological diagnosis of AD as a cause of cognitive impairment; whereas, a positive scan indicates moderate-to-frequent amyloid neuritic plaques

Moderate-to-frequent amyloid plagues are found in patients with AD, but may also be present in with other types of neurologic conditions as well as older people with normal cognition

Dosage

  • 370 MBq (10 mCi) as a single IV bolus injection in a total volume of 10 mL or less; follow bolus injection 0.9% NaCl IV flush
  • Not to exceed 50 mcg mass dose
  • Inject through a short IV catheter (~1.5 inches or less) to minimize the potential for adsorption of the drug to the catheter

Limitations of use

  • Positive scan does not establish a diagnosis of AD or other cognitive disorder
  • Safety and effectiveness have not been established for: 1) predicting development of dementia or other neurologic condition; 2) monitoring responses to therapies

Image Display & Interpretation

A 10-minute PET image should be acquired starting 30-50 minutes after IV injection

The patient should be supine; position head to center the brain, including the cerebellum, in the PET scanner field of view

Reduce head movement with tape or other flexible head restraints may be employed

Image reconstruction should include attenuation correction with resulting transaxial pixel sizes between 2 and 3 mm

Display

  • Display images in the transaxial orientation with access as needed to the sagittal and coronal planes
  • In reviewing the images, include all transaxial slices of the brain using a black-white scale with the maximum intensity of the scale set to the maximum intensity of all the brain pixels
  • Initially locate the brain slice with the highest levels of image contrast (highest radioactivity signals for florbetapir uptake) and adjust the contrast appropriately
  • Start image interpretation by displaying slices sequentially from the bottom of the brain to the top
  • Periodically refer to the sagittal and coronal plane image display, as needed to better define the radioactivity uptake and to ensure that the entire brain is displayed

Interpretation

  • Image interpretation is based upon the distribution of radioactive signal within the brain; clinical information is not a component of the image assessment
  • Images are designated as positive or negative by comparing the radioactivity in cortical gray matter with activity in the adjacent white matter; this determination is made only in the cerebral cortex; the signal uptake in the cerebellum does not contribute to the scan interpretation (for example, a positive scan may show retained cerebellar gray-white contrast even when the cortical gray-white contrast is lost)
  • Negative scans show more radioactivity in white matter than in gray matter, creating clear gray-white contrast
  • Positive scans show cortical areas with reduction or loss of the normally distinct gray-white contrast; these scans have one or more areas with increased cortical gray matter signal which results in reduced (or absent) gray-white contrast
  • Specifically, a positive scan will have either: a) 2 or more brain areas (each larger than a single cortical gyrus) in which there is reduced or absent gray-white contrast; this is the most common appearance of a positive scan, OR b) 1 or more areas in which gray matter radioactivity is intense and clearly exceeds radioactivity in adjacent white matter
  • See figures of PET images in the prescribing information for further information

Not indicated

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Adverse Effects

1-10%

Headache (1.8%)

<1%

Musculoskeletal pain (0.8%)

Fatigue (0.6%)

Nausea (0.6%)

Anxiety (0.4%)

Back pain (0.4%)

Increased blood pressure (0.4%)

Claustrophobia (0.4%)

Feeling cold (0.4%)

Insomnia (0.4%)

Neck pain (0.4%)

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Warnings

Contraindications

None

Cautions

Risk for image misinterpretation

  • Errors may occur in the estimation of brain neuritic plaque density during image interpretation; perform image interpretation independently of the patient’s clinical information
  • Other errors may be due to extensive brain atrophy that limits the ability to distinguish gray and white matter on the scan as well as motion artifacts that distort the image

Radiation risk

  • Similar to other radiopharmaceuticals, florbetapir F 18 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
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Pregnancy & Lactation

Pregnancy Category: C; should be administered to a pregnant woman only if clearly needed; all radiopharmaceuticals have potential to cause fetal harm

The likelihood of fetal harm depends on the stage of fetal development and the magnitude of the radiopharmaceutical dose

Assess pregnancy status before administering to a female of reproductive potential

Lactation: Unknown whether distributed in breast milk; avoid use in breastfeeding women or temporarily interrupt breastfeeding for 24 hr (>10 half-lives of radioactive decay for the F 18 isotope) after exposure

If breastfeeding is interrupted, the patient should pump and discard her breast milk and use alternate infant nutrition sources (eg, stored breast milk or infant formula) for 24 hr after administration

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Binds to beta-amyloid plaques 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 beta-amyloid plaques, the dissociation constant (Kd) for florbetapir was 3.7± 0.3 nM

Distribution

Rapidly distributed throughout body

<5% of the injected F 18 radioactivity present in the blood by 20 minutes following administration, and less than 2% present by 45 minutes after administration

Elimination

Half-life: 109.77 minutes (F 18)

Excretion: Principally via feces (GI and bile), small amount in urine

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Administration

IV Preparation

Must not be diluted

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 solution

Assay the dose in a suitable dose calibrator prior to administration

Radiation safety

  • Radioactive drug; handle with appropriate safety measures to minimize radiation exposure during administration
  • Use waterproof gloves and effective shielding, including lead-glass syringe shields when handling
  • Radiopharmaceuticals should only be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radioactive materials, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radiopharmaceuticals

IV Administration

Inject through a short IV catheter (~1.5 inches or less) to minimize the potential for adsorption of the drug to the catheter

Portions of the dose may adhere to longer catheters

Administer as single IV bolus injection in a total volume of 10 mL or less; follow bolus injection 0.9% NaCl IV flush

Not to exceed 50 mcg mass dose

Storage

Store at 25ºC (77°F); excursions permitted to 15-30ºC (59-86°F)

The product does not contain a preservative

Store within the original container or equivalent radiation shielding

This preparation is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State

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Images

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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Code Definition
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Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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