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Full Prescribing Information


Medication Guide

Prescribing Information

Medication Guide

For agitation that may happen with dementia due to Alzheimer’s disease

Clinically proven to quickly reduce
the frequency of agitation

People who took AUVELITY for 5 weeks had fewer agitation symptoms on average than people on placebo

In a 5-week study of 308 people with agitation, AUVELITY significantly reduced agitation symptoms by an average of 14.9 points, compared to 11.6 points with placebo. Measured on a standardized scale that assessed the frequency of agitation symptoms.

In a 6-month study of people who responded very well to AUVELITY

AUVELITY delayed the time to agitation symptoms getting worse

compared to people who switched to placebo*

At the end of 6 months, 3.4x more people on placebo had worsening of agitation symptoms compared to those on AUVELITY

8.4% of people on AUVELITY had worsening of agitation symptoms vs 28.6% of people who switched to placebo*

Based on a study of 167 people with Alzheimer‘s disease who showed lasting improvement in agitation symptoms while taking AUVELITY and then were randomly assigned to either continue AUVELITY or switch to a placebo to see if there was a difference in agitation symptoms between the 2 groups over a 6-month period.

*

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WHAT IS AUVELITY?

IMPORTANT SAFETY INFORMATION



WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT AUVELITY?

WHAT IS AUVELITY (AW-VEHL-AH-TEE)? It is a prescription oral medicine used to treat agitation that may happen with dementia due to Alzheimer’s disease.

Do not take AUVELITY if you:

  • have or had a seizure disorder.
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