Questions & Answers
Frequently asked questions about agitation that may happen with dementia due to Alzheimer's disease and REXULTI
Here you’ll find answers to the most common questions having to do with agitation that may happen with dementia due to Alzheimer's disease and REXULTI. Keep in mind, your loved one’s doctor is the best source of information for any questions you may have.
Questions about agitation that may happen with dementia due to Alzheimer's disease
If a person has Alzheimer's dementia and begins to develop agitation that may happen with dementia due to Alzheimer's disease, behavioral shifts will start to become more apparent. Irritability, aggressiveness (verbal and/or physical), or restlessness—these are all signs that your loved one may have agitation that may happen with dementia due to Alzheimer's disease. Discuss these symptoms with your loved one's doctor.
Click here to take the symptom questionnaire.
A person with agitation that may happen with dementia due to Alzheimer's disease will generally show signs of verbal aggression (screaming, swearing, complaining), physical aggression (kicking, spitting, hitting), and/or restlessness (pacing, jumpiness, repetitive mannerisms). The symptoms of agitation that may happen with dementia due to Alzheimer's disease that a person shows may seem out of character.
Click here for a full list of symptoms to look out for.
About 6.7 million elderly people (aged 65 and older) in the US have Alzheimer's dementia. Studies suggest that about half or more will develop agitation that may happen with dementia due to Alzheimer's disease.
Alzheimer's dementia mainly affects cognitive functions, causing things like memory loss, disorientation, and a general mental confusion amongst other symptoms. With agitation that may happen with dementia due to Alzheimer's disease, a person’s outward behavior begins to shift towards aggression, whether physical or verbal, and/or a sense of general restlessness. An irritability may develop that seems uncharacteristic in this person.
There isn’t one solution to fit every situation, but here's a few general ways that may help your loved one cope.
Reassure them. Listen to their frustrations or concerns and try to show you understand.
Create a warm atmosphere. Sometimes a gentle touch or relaxing music can help. Reading and going on walks can also have positive impacts.
Find a distraction. Refocusing their attention to a hobby or activity they love, or even simply their favorite snack may help.
Everyone's situation is different, and each person is at a different point in their condition's development. Wherever your loved one may be in their treatment journey, use this Doctor Discussion Guide to help get their conversation started about your loved one's symptoms and what steps to take.
Questions about REXULTI
REXULTI is taken once daily, with or without food. It’s important to talk to your loved one’s pharmacist or healthcare provider if either of you have any questions about taking REXULTI.
- Have your loved one take REXULTI as their healthcare provider prescribed it.
- Do not change the dose or have your loved one stop taking REXULTI without first talking to their healthcare provider. Only their healthcare provider may change the dose if needed.
- Your loved one should not take REXULTI if they are allergic to brexpiprazole or any of the ingredients in REXULTI.
- If they take too much REXULTI, call their healthcare provider or the Poison Help Line at
1-800-222-1222 right away or go to the nearest hospital emergency room.
REXULTI should not be used as an "as needed" treatment for agitation that may happen with dementia due to Alzheimer's disease.
Not everyone responds to medication the same way, and your loved one’s body may need time to adapt. Therefore, it is important to share how they have been feeling with their healthcare provider, including any side effects. This way, he or she will better understand what effect their treatment may be having and adjust if necessary. Write down questions you have about their treatment and share them with the doctor. Always talk to your loved one’s doctor before making any changes to their treatment. Individual results may vary.
Before taking REXULTI, tell your loved one's healthcare provider about all of their medical conditions, including if they:
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have or have had heart problems or a stroke
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have or have had low or high blood pressure
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have or have had diabetes or high blood sugar or a family history of diabetes or high blood sugar. Your loved one's healthcare provider should check their blood sugar before they start REXULTI and during treatment with REXULTI.
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have or have had high levels of total cholesterol, LDL cholesterol, or triglycerides, or low levels of HDL cholesterol
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have or have had seizures (convulsions)
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have or have had kidney or liver problems
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have or have had a low white blood cell count
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are pregnant or plan to become pregnant. REXULTI may harm their unborn baby. Taking REXULTI during their third trimester of pregnancy may cause their baby to have abnormal muscle movements or withdrawal symptoms after birth. Talk to your loved one’s healthcare provider about the risk to their unborn baby if they take REXULTI during pregnancy.
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Tell their healthcare provider if they become pregnant or think they are pregnant during treatment with REXULTI.
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There is a pregnancy exposure registry for women who are exposed to REXULTI during pregnancy. If they become pregnant during treatment with REXULTI, talk to their healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling
1-866-961-2388 or visit
http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry.
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are breastfeeding or plan to breastfeed. It is not known if REXULTI passes into breast milk. Talk to their healthcare provider about the best way to feed their baby during treatment with REXULTI.
Tell your loved one's healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
REXULTI and other medicines may affect each other causing possible serious side effects. REXULTI may affect the way other medicines work, and other medicines may affect how REXULTI works.
Your loved one's healthcare provider can tell you if it is safe to take REXULTI with their other medicines. Do not start or stop any medicines during treatment with REXULTI without first talking to your loved one’s healthcare provider.
Know the medicines they take. Keep a list of them to show their healthcare provider and pharmacist when they get a new medicine.
Questions about side effects from REXULTI
Take note of any side effects your loved one experiences while on REXULTI and report them to their healthcare provider, especially if they are new, worsening, or worry you.
Do not have your loved one take REXULTI if they are allergic to brexpiprazole or any of the ingredients in REXULTI.
REXULTI may cause serious side effects, including:
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Increased risk of death in elderly people with dementia-related psychosis. Medicines like REXULTI can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). REXULTI is not approved for the treatment of people with dementia-related psychosis without agitation that may happen with dementia due to Alzheimer’s disease.
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Increased risk of suicidal thoughts and actions. REXULTI and antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed.
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Cerebrovascular problems, including stroke, in elderly people with dementia-related psychosis that can lead to death.
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Neuroleptic malignant syndrome (NMS) is a serious condition that can lead to death.
Call your loved one's healthcare provider or go to the nearest hospital emergency room right away if they have some or all of the following signs and symptoms of NMS: high fever; changes in pulse, blood pressure, heart rate, and breathing; stiff muscles; confusion; or increased sweating. -
Uncontrolled body movements (tardive dyskinesia)
REXULTI may cause movements that your loved one cannot control in their face, tongue or other body parts, which may not go away. -
High blood sugar (hyperglycemia) and diabetes
Increases in blood sugar can happen in some people who take REXULTI, and extremely high blood sugar can lead to coma or death. -
Increased fat levels (cholesterol and triglycerides) in their blood
Your loved one's healthcare provider should check the fat levels in your loved one's blood before they start, or soon after they start REXULTI, and then periodically during treatment with REXULTI. -
Weight gain
Your loved one's healthcare provider should check their weight before they start and often during treatment with REXULTI. -
Unusual and uncontrollable (compulsive) urges.
Some people taking REXULTI have had strong unusual urges, to gamble and gambling that cannot be controlled (compulsive gambling). Other compulsive urges include sexual urges, shopping, and eating or binge eating. If you or your family members notice that your loved one is having new or unusual strong urges or behaviors, talk to their healthcare provider. -
Low white blood cell count
Your loved one's healthcare provider may do blood tests during the first few months of treatment with REXULTI. -
Decreased blood pressure (orthostatic hypotension) and fainting
Your loved one may feel dizzy, lightheaded, or pass out (faint) when they rise quickly from a sitting or lying position. -
Falls
REXULTI may make your loved one sleepy or dizzy, may cause a decrease in their blood pressure when changing position (orthostatic hypotension), and can slow their thinking and motor skills which may lead to falls that can cause fractures or other injuries. -
Seizures (convulsions)
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Problems controlling your loved one's body temperature so that your loved one feels too warm
Do not become too hot or dehydrated during treatment with REXULTI. -
Difficulty swallowing
This may cause food or liquid to get into your loved one's lungs. -
Sleepiness, drowsiness, feeling tired, difficulty thinking and doing normal activities.
Your loved one should not drive a car, operate machinery, or do other dangerous activities until they know how REXULTI affects them. REXULTI may make them feel drowsy.
The most common side effects for all indications of REXULTI include weight gain, sleepiness, dizziness, common cold symptoms, and restlessness or feeling like you need to move (akathisia). See below for more information on REXULTI clinical trials in patients with agitation that may happen with dementia due to Alzheimer's disease.
An increase in blood sugar (hyperglycemia) can happen in some people who take REXULTI. Extremely high blood sugar can lead to coma or death. Your loved one's healthcare provider should check their blood sugar before they start, or soon after they start REXULTI and then regularly during long-term treatment with REXULTI.
Call your loved one's healthcare provider if they have any of these symptoms of high blood sugar while taking REXULTI: They feel very thirsty; feel very hungry; feel sick to their stomach; need to urinate more than usual; feel weak or tired; feel confused, or their breath smells fruity.
An increase in the fat levels (cholesterol and triglycerides) in your loved one’s blood may occur while taking REXULTI. Before starting on REXULTI, discuss with their healthcare provider if they have high levels of cholesterol, triglycerides, or LDL cholesterol, or low levels of HDL cholesterol.
Your loved one’s healthcare provider should check the fat levels in their blood before they start, or soon after they start REXULTI, and then periodically during treatment with REXULTI.
During clinical trials for agitation that may happen with dementia due to Alzheimer's disease,* changes in total cholesterol, LDL cholesterol, and HDL cholesterol were similar in patients treated with REXULTI and patients treated with placebo.
REXULTI may make your loved one feel drowsy. Do not allow your loved one to drive a car, operate machinery, or do other dangerous activities until you know how REXULTI affects your loved one.
During clinical trials for agitation that may happen with dementia due to Alzheimer's disease,* sleepiness was reported in 3% of patients treated with REXULTI compared to 1% of patients treated with placebo.
REXULTI may cause restlessness or feeling the need to continuously move (akathisia).
During clinical trials for agitation that may happen with dementia due to Alzheimer's disease,* the incidence of akathisia events for REXULTI-treated patients was 1% versus 0% for placebo-treated patients.
*Researchers studied REXULTI in clinical trials.
REXULTI was studied in two 12-week clinical trials in patients aged 51-90 with agitation that may happen with dementia due to Alzheimer's disease. At the end of the 12 weeks, patients who took
REXULTI experienced a greater improvement in their symptoms of agitation compared to those who took a placebo.