Indication and Important Safety Information About Amyvid

Indications and Usage
Amyvid™ (Florbetapir F 18 Injection) for intravenous use 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. 


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. 

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 condition 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. Additionally, the safety and effectiveness of Amyvid have not been established for predicting development of dementia or other neurologic condition or monitoring responses to therapies. 

Amyvid for intravenous use is supplied in 10 mL, 30 mL, or 50 mL multidose vials containing 500-1900 MBq/mL Florbetapir F 18.

Important Safety Information

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 (0.8%), fatigue (0.6%), nausea (0.6%), anxiety (0.4%), back pain (0.4%), blood pressure increased (0.4%), claustrophobia (0.4%), feeling cold (0.4%), insomnia (0.4%), neck pain (0.4%).

DRUG INTERACTIONS
Pharmacodynamic drug-drug interaction studies have not been performed in patients to establish the extent, if any, to which concomitant medications may alter Amyvid image results. 

For Full Prescribing Information, visit http://pi.lilly.com/us/amyvid-uspi.pdf. 

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Amyvid™ is a trademark of Eli Lilly and Company. AM78097