Amyvid logo
  • Meet Carol*
  • Clinical Assessment†
  • Imaging Report

*Hypothetical patient.

The objective of Amyvid image interpretation is to provide an estimate of the brain beta-amyloid neuritic plaque density, not to make a clinical diagnosis. Image interpretation is performed independently of a patient’s clinical features and relies upon the recognition of unique image features.

†Image interpretation should be performed independently of the patient’s clinical information. The use of clinical information in the interpretation of Amyvid images has not been evaluated and may lead to errors.

‡Amyvid PET scans are interpreted independently of the patient's clinical information.

The objective of Amyvid image interpretation is to provide an estimate of the brain beta-amyloid neuritic plaque density, not to make a clinical diagnosis. Image interpretation is performed independently of a patient’s clinical features and relies upon the recognition of unique image features.

  • 70 YEAR-OLD ART TEACHER―Widowed Since 2012
  • ENJOYS PAINTING and being with her 3 grandchildren
  • Arrives 30 mins late for her visit, seems anxious
  • Describes her morning as "CHAOS" trying to get her grandchildren to school
  • Reports more difficulty with memory for the past 2 years and asks, "THIS IS JUST NORMAL FOR MY AGE, RIGHT? "
  • Repeated the same story about her morning twice
  • MMSE 26/30
  • Complete history and physical are normal,
    including neurologic exam—reveals no focal deficits
  • Routine lab tests normal, as well as TSH, B12, and folate
  • Structural MRI is read as "age appropriate atrophy"
  • Diagnosis is persistent MCI: Follow-up scheduled in 2 weeks—family member is requested to attend
  • An Amyvid PET scan is ordered to differentiate diagnosis and decide, along with Carol, on appropriate management

Example of a positive Amyvid PET scan imaging report.

POSITIVE scan‡

  • Indicates presence of significant (moderate to frequent) amyloid neuritic plaques1
  • Consistent with a neuropathological diagnosis of AD1
  • 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 cognition1
  • Amyvid is an adjunct to other diagnostic evaluations. A positive Amyvid scan does not establish a diagnosis of AD or other cognitive disorder. The safety and effectiveness of Amyvid have not been established for predicting the development of dementia or other neurologic condition, or for monitoring responses to therapies1
  • Meet George*
  • Clinical Assessment†
  • Imaging Report

*Hypothetical patient.

The objective of Amyvid image interpretation is to provide an estimate of the brain beta-amyloid neuritic plaque density, not to make a clinical diagnosis. Image interpretation is performed independently of a patient’s clinical features and relies upon the recognition of unique image features.

†Image interpretation should be performed independently of the patient’s clinical information. The use of clinical information in the interpretation of Amyvid images has not been evaluated and may lead to errors.

‡Amyvid PET scans are interpreted independently of the patient's clinical information.

The objective of Amyvid image interpretation is to provide an estimate of the brain beta-amyloid neuritic plaque density, not to make a clinical diagnosis. Image interpretation is performed independently of a patient’s clinical features and relies upon the recognition of unique image features.

  • 71 YEAR-OLD ACCOUNTANT with cognitive concerns
  • ACCOMPANIED TO DOCTOR’S OFFICE
    by his wife of 40 years
  • Wife describes his
    PROGRESSIVE CHANGE OVER THE PAST 3 YEARS
    • Gradually lost ability to work with numbers; his wife now manages their finances
    • Used to enjoy lively dinner conversation; now he is less talkative
    • His memory is worse, but sometimes recalls nearly everything
  • GEORGE IS FRUSTRATED by these changes
  • MOCA 24/30
    with errors in recall, calculation,
    attention, and visuospatial skills
  • Medical history is remarkable for hypertension, type 2 diabetes, and gout. No previous stroke symptoms
  • Normal physical and neurologic exams
  • Routine lab tests normal, as well as B12, folate, and TSH
  • Structural MRI outcomes: small bilateral lacunar infarcts, small vessel ischemic changes, and age-appropriate atrophy
  • An Amyvid PET scan is ordered due to the progressive nature of George’s cognitive decline and uncertain diagnosis

Example of a negative Amyvid PET scan imaging report.

NEGATIVE scan‡

  • Indicates sparse to no neuritic plaques1
  • The negative scan is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition, and makes it unlikely that George’s cognitive impairment is due to AD1
  • Meet Wanda*
  • Clinical Assessment†
  • Imaging Report

*Hypothetical patient.

The objective of Amyvid image interpretation is to provide an estimate of the brain beta-amyloid neuritic plaque density, not to make a clinical diagnosis. Image interpretation is performed independently of a patient’s clinical features and relies upon the recognition of unique image features.

†Image interpretation should be performed independently of the patient’s clinical information. The use of clinical information in the interpretation of Amyvid images has not been evaluated and may lead to errors.

  • 65 YEAR-OLD PRACTICING NURSE
  • MOTHER DIAGNOSED WITH AD
    at age 65, now deceased
  • MATERNAL GRANDFATHER
    DIAGNOSED     with dementia
  • Always organized but
    NOW MISPLACING ITEMS
  • Sometimes feels “FOGGY”
    when she wakes up in the morning
  • ANXIOUS ABOUT AD given her family history
  • MOCA 30/30
  • Medical history: Lumbar laminectomy (back surgery) 6 months ago—otherwise unremarkable
  • Medications: Takes acetaminophen for pain, an OTC sleep aid, and a multivitamin daily
  • General exams: Physical and neurological
    examinations normal
  • Routine lab tests: B12, folate, and TSH—
    all within normal limits

AMYVID PET SCAN
NOT INDICATED

Follow-up 6 months later...

  • Wanda is reevaluated for her cognitive concerns

Clinical Assessment

  • No change in symptoms
  • MOCA 30/30
  • Routine follow-up is scheduled for continued monitoring

START TRAINING
References
  1. Amyvid [package insert]. Indianapolis, IN: Eli Lilly and Company; 2013.
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INDICATION AND IMPORTANT SAFETY INFORMATION FOR AMYVID (Florbetapir F 18 Injection)
INDICATIONS AND USAGE

Amyvid is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate beta-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 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. Amyvid is an adjunct to other diagnostic evaluations.

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

Amyvid for intravenous use is supplied in multidose vials containing
500-1900 MBq/mL Florbetapir F 18.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS

Risk for Image Misinterpretation and Other Errors

  • Errors may occur in the Amyvid estimation of brain neuritic plaque density during image interpretation
  • Image interpretation should be performed independently of the patient's clinical information. The use of clinical information in the interpretation of Amyvid images has not been evaluated and may lead to errors. Other errors may be due to extensive brain atrophy that limits the ability to distinguish gray and white matter on the Amyvid scan as well as motion artifacts that distort the image
  • 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

Radiation Risk

  • Amyvid, 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
MOST COMMON ADVERSE REACTIONS
  • The most common adverse reactions reported in clinical trials were headache (1.8%), musculoskeletal pain (0.7%), blood pressure increased (0.7%), nausea (0.7%), fatigue (0.5%), and injection site reaction (0.5%)

Please see Full Prescribing Information for Amyvid.

AM HCP ISI 10JAN2014