Meet Wanda*

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

*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.

Clinical Assessment: Atypical Symptoms

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

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.

SELECT 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
  • 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 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

INDICATION

Amyvid is a radioactive diagnostic agent 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.

Amyvid for intravenous use is supplied in multidose vials containing 500-1900 MBq/mL Florbetapir F 18.

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

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