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.
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
MOST COMMON ADVERSE REACTIONS
- 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
- The most common adverse reactions reported in clinical trials were headache (1.8%), musculoskeletal pain (0.8%), fatigue (0.6%), nausea (0.6%)
For Full Prescribing Information for Amyvid, visit
AM HCP ISI 05OCT2012
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in
, Lilly provides answers—through medicines and information—for some of the world's most urgent medical needs. Additional information about Lilly is available at
This press release contains certain forward-looking statements about Amyvid™ (Florbetapir F 18 Injection), a radioactive diagnostic agent indicated for brain imaging of beta-amyloid plaques in patients with cognitive impairment who are being evaluated for Alzheimer's Disease and other causes of cognitive decline. This release reflects Lilly's current beliefs; however, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. There is no guarantee that future study results and patient experience will be consistent with study findings to date or that Amyvid will prove to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.
, LLC 2013. All rights reserved. AM81786 01/2013
Amyvid™ is a trademark of Eli Lilly and Company.