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* U.S. FULL PRESCRIBING INFORMATION, including BOXED WARNING
* MEDICATION GUIDE
* U.S. Healthcare Professionals
* Other Indication
Savings & Cost
* Choose a Condition
* Depression
* Agitation that may happen with dementia due to Alzheimer's disease
* Home
* Depression
* Agitation that may happen with dementia due to Alzheimer's disease
* Savings & Cost
* Commercial Insurance
* Medicare
* Medicaid
* VA or TRICARE
* Uninsured
* Savings & Cost
Depression
Agitation that may happen with
dementia due to Alzheimer’s disease
Actor portrayals
SEE HOW REXULTI® (BREXPIPRAZOLE) COULD HELP.
CHOOSE A CONDITION
Depression
Agitation that may happen with dementia due to Alzheimer’s disease
ISI Block Title
IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR REXULTI® (BREXPIPRAZOLE)
IMPORTANT SAFETY INFORMATION:
* 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.
* 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. Depression and other mental illnesses are the most
important causes of suicidal thoughts and actions. Patients on
antidepressants and their families or caregivers should watch for new or
worsening depression symptoms, especially sudden changes in mood, behaviors,
thoughts, or feelings. Report any change in these symptoms immediately to the
doctor.
Do not take REXULTI if you are allergic to brexpiprazole or any of the
ingredients in REXULTI.
REXULTI may cause serious side effects, including:
* Cerebrovascular problems, including stroke, in elderly people with
dementia-related psychosis that can lead to death.
* Neuroleptic malignant syndrome (NMS) is a serious condition that can lead to
death. Call your healthcare provider or go to the nearest hospital emergency
room right away if you have some or all of the following signs and symptoms
of NMS: high fever; changes in your pulse, blood pressure, heart rate, and
breathing; stiff muscles; confusion; increased sweating.
* Uncontrolled body movements (tardive dyskinesia). REXULTI may cause movements
that you cannot control in your face, tongue, or other body parts. Tardive
dyskinesia may not go away, even if you stop taking REXULTI. Tardive
dyskinesia may also start after you stop taking REXULTI.
* Problems with your metabolism such as:
* high blood sugar (hyperglycemia) and diabetes. Increases in blood sugar can
happen in some people who take REXULTI. Extremely high blood sugar can lead
to coma or death. Your healthcare provider should check your blood sugar
before you start, or soon after you start REXULTI and then regularly during
long term treatment with REXULTI.
Call your healthcare provider if you have any of these symptoms of high
blood sugar during treatment with REXULTI:
* feel very thirsty
* feel very hungry
* feel sick to your stomach
* need to urinate more than usual
* feel weak or tired
* feel confused, or your breath
smells fruity
* increased fat levels (cholesterol and triglycerides) in your blood.
Your healthcare provider should check the fat levels in your blood before
you start, or soon after you start REXULTI, and then periodically during
treatment with REXULTI.
* weight gain. You and your healthcare provider should check your weight
before you 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 you are having new or unusual strong urges or behaviors, talk to
your healthcare provider.
* Low white blood cell count. Your healthcare provider may do blood tests
during the first few months of treatment with REXULTI.
* Decreased blood pressure (orthostatic hypotension) and fainting. You may feel
dizzy, lightheaded or pass out (faint) when you rise too quickly from a
sitting or lying position.
* Falls. REXULTI may make you sleepy or dizzy, may cause a decrease in your
blood pressure when changing position (orthostatic hypotension), and can slow
your thinking and motor skills which may lead to falls that can cause
fractures or other injuries.
* Seizures (convulsions).
* Problems controlling your body temperature so that you feel too warm. Do not
become too hot or dehydrated during treatment with REXULTI. Do not exercise
too much. In hot weather, stay inside in a cool place if possible. Stay out
of the sun. Do not wear too much clothing or heavy clothing. Drink plenty of
water.
* Difficulty swallowing that can cause food or liquid to get into your lungs.
* Sleepiness, drowsiness, feeling tired, difficulty thinking and doing normal
activities. Do not drive a car, operate machinery, or do other dangerous
activities until you know how REXULTI affects you. REXULTI may make you feel
drowsy.
Before taking REXULTI, tell your healthcare provider about all of your medical
conditions, including if you:
* have or have had heart problems or a stroke
* have or have had low or high blood pressure
* have or have had diabetes or high blood sugar or a family history of diabetes
or high blood sugar. Your healthcare provider should check your blood sugar
before you start REXULTI and during treatment with REXULTI.
* have or have had high levels of total cholesterol, LDL cholesterol, or
triglycerides, or low levels of HDL cholesterol
* have or have had seizures (convulsions)
* have or have had kidney or liver problems
* have or have had a low white blood cell count
* are pregnant or plan to become pregnant. REXULTI may harm your unborn baby.
Taking REXULTI during your third trimester of pregnancy may cause your baby
to have abnormal muscle movements or withdrawal symptoms after birth. Talk to
your healthcare provider about the risk to your unborn baby if you take
REXULTI during pregnancy.
* Tell your healthcare provider if you become pregnant or think you are
pregnant during treatment with REXULTI.
* There is a pregnancy exposure registry for women who are exposed to REXULTI
during pregnancy. If you become pregnant during treatment with REXULTI,
talk to your 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/.
* are breastfeeding or plan to breastfeed. It is not known if REXULTI passes
into your breast milk. Talk to your healthcare provider about the best way to
feed your baby during treatment with REXULTI.
Tell your healthcare provider about all the medicines you 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 healthcare provider can tell you if it is
safe to take REXULTI with your other medicines. Do not start or stop any
medicines during treatment with REXULTI without first talking to your healthcare
provider.
The most common side effects of REXULTI include weight gain, sleepiness,
dizziness, common cold symptoms, and restlessness or feeling like you need to
move (akathisia).
These are not all the possible side effects of REXULTI. For more information,
ask your healthcare provider or pharmacist.
You are encouraged to report side effects of REXULTI (brexpiprazole). Please
contact Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 or FDA at
1-800-FDA-1088 (www.fda.gov/medwatch).
INDICATIONS:
REXULTI is a prescription medicine used:
* along with antidepressant medicines to treat major depressive disorder (MDD)
in adults
* to treat agitation that may happen with dementia due to Alzheimer’s disease
REXULTI should not be used as an “as needed” treatment for agitation that may
happen with dementia due to Alzheimer’s disease.
It is not known if REXULTI is safe and effective in children with MDD.
Please read FULL PRESCRIBING INFORMATION, including BOXED WARNING, and
MEDICATION GUIDE.
INDICATIONS:
REXULTI is a prescription medicine used:
* along with antidepressant medicines to treat major depressive disorder (MDD)
in adults
* to treat agitation that may happen with dementia due to Alzheimer’s disease
REXULTI should not be used as an “as needed” treatment for agitation that may
happen with dementia due to Alzheimer’s disease.
It is not known if REXULTI is safe and effective in children with MDD.
INDICATIONS for REXULTI® (brexpiprazole)
REXULTI is a prescription medicine used:
* along with antidepressant medicines to treat major depressive disorder (MDD)
in adults
* to treat agitation that may happen with dementia due to Alzheimer’s disease
REXULTI should not be used as an “as needed” treatment for agitation that may
happen with dementia due to Alzheimer’s disease.
It is not known if REXULTI is safe and effective in children with MDD.
IMPORTANT SAFETY INFORMATION AND INDICATION for REXULTI® (brexpiprazole)
IMPORTANT SAFETY INFORMATION:
* 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.
* 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. Depression and other mental illnesses are the most
important causes of suicidal thoughts and actions. Patients on
antidepressants and their families or caregivers should watch for new or
worsening depression symptoms, especially sudden changes in mood, behaviors,
thoughts, or feelings. Report any change in these symptoms immediately to the
doctor.
Do not take REXULTI if you are allergic to brexpiprazole or any of the
ingredients in REXULTI.
REXULTI may cause serious side effects, including:
* Cerebrovascular problems, including stroke, in elderly people with
dementia-related psychosis that can lead to death.
* Neuroleptic malignant syndrome (NMS) is a serious condition that can lead to
death. Call your healthcare provider or go to the nearest hospital emergency
room right away if you have some or all of the following signs and symptoms
of NMS: high fever; changes in your pulse, blood pressure, heart rate, and
breathing; stiff muscles; confusion; increased sweating.
* Uncontrolled body movements (tardive dyskinesia). REXULTI may cause movements
that you cannot control in your face, tongue, or other body parts. Tardive
dyskinesia may not go away, even if you stop taking REXULTI. Tardive
dyskinesia may also start after you stop taking REXULTI.
* Problems with your metabolism such as:
* high blood sugar (hyperglycemia) and diabetes. Increases in blood sugar can
happen in some people who take REXULTI. Extremely high blood sugar can lead
to coma or death. Your healthcare provider should check your blood sugar
before you start, or soon after you start REXULTI and then regularly during
long term treatment with REXULTI.
Call your healthcare provider if you have any of these symptoms of high
blood sugar during treatment with REXULTI:
* feel very thirsty
* feel very hungry
* feel sick to your stomach
* feel weak or tired
* need to urinate more than usual
* feel confused, or your breath smells fruity
* increased fat levels (cholesterol and triglycerides) in your blood.
Your healthcare provider should check the fat levels in your blood before
you start, or soon after you start REXULTI, and then periodically during
treatment with REXULTI.
* weight gain. You and your healthcare provider should check your weight
before you 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 you are having new or unusual strong urges or behaviors, talk to
your healthcare provider.
* Low white blood cell count. Your healthcare provider may do blood tests
during the first few months of treatment with REXULTI.
* Decreased blood pressure (orthostatic hypotension) and fainting. You may feel
dizzy, lightheaded or pass out (faint) when you rise too quickly from a
sitting or lying position.
* Falls. REXULTI may make you sleepy or dizzy, may cause a decrease in your
blood pressure when changing position (orthostatic hypotension), and can slow
your thinking and motor skills which may lead to falls that can cause
fractures or other injuries.
* Seizures (convulsions).
* Problems controlling your body temperature so that you feel too warm. Do not
become too hot or dehydrated during treatment with REXULTI. Do not exercise
too much. In hot weather, stay inside in a cool place if possible. Stay out
of the sun. Do not wear too much clothing or heavy clothing. Drink plenty of
water.
* Difficulty swallowing that can cause food or liquid to get into your lungs.
* Sleepiness, drowsiness, feeling tired, difficulty thinking and doing normal
activities. Do not drive a car, operate machinery, or do other dangerous
activities until you know how REXULTI affects you. REXULTI may make you feel
drowsy.
Before taking REXULTI, tell your healthcare provider about all of your medical
conditions, including if you:
* have or have had heart problems or a stroke
* have or have had low or high blood pressure
* have or have had diabetes or high blood sugar or a family history of diabetes
or high blood sugar. Your healthcare provider should check your blood sugar
before you start REXULTI and during treatment with REXULTI.
* have or have had high levels of total cholesterol, LDL cholesterol, or
triglycerides, or low levels of HDL cholesterol
* have or have had seizures (convulsions)
* have or have had kidney or liver problems
* have or have had a low white blood cell count
* are pregnant or plan to become pregnant. REXULTI may harm your unborn baby.
Taking REXULTI during your third trimester of pregnancy may cause your baby
to have abnormal muscle movements or withdrawal symptoms after birth. Talk to
your healthcare provider about the risk to your unborn baby if you take
REXULTI during pregnancy.
* Tell your healthcare provider if you become pregnant or think you are
pregnant during treatment with REXULTI.
* There is a pregnancy exposure registry for women who are exposed to REXULTI
during pregnancy. If you become pregnant during treatment with REXULTI,
talk to your 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/.
* are breastfeeding or plan to breastfeed. It is not known if REXULTI passes
into your breast milk. Talk to your healthcare provider about the best way to
feed your baby during treatment with REXULTI.
Tell your healthcare provider about all the medicines you 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 healthcare provider can tell you if it is
safe to take REXULTI with your other medicines. Do not start or stop any
medicines during treatment with REXULTI without first talking to your healthcare
provider.
The most common side effects of REXULTI include weight gain, sleepiness,
dizziness, common cold symptoms, and restlessness or feeling like you need to
move (akathisia).
These are not all the possible side effects of REXULTI. For more information,
ask your healthcare provider or pharmacist.
You are encouraged to report side effects of REXULTI (brexpiprazole). Please
contact Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 or FDA at
1-800-FDA-1088 (www.fda.gov/medwatch).
Please read FULL PRESCRIBING INFORMATION, including BOXED WARNING, and
MEDICATION GUIDE.
INDICATIONS:
REXULTI is a prescription medicine used:
* along with antidepressant medicines to treat major depressive disorder (MDD)
in adults
* to treat agitation that may happen with dementia due to Alzheimer’s disease
REXULTI should not be used as an “as needed” treatment for agitation that may
happen with dementia due to Alzheimer’s disease.
It is not known if REXULTI is safe and effective in children with MDD.
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* PRESCRIBING INFORMATION
* MEDICATION GUIDE
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