Rexulti Special Precautions

Increased Mortality in Elderly Patients with Dementia-Related Psychosis: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group.
Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Brexpiprazole (Rexulti) is not approved for the treatment of patients with dementia-related psychosis without agitation associated with dementia due to Alzheimer's disease [see Warnings and Cerebrovascular Adverse Reactions Including Stroke in Elderly Patients with Dementia-Related Psychosis as follows].
Suicidal Thoughts and Behaviors in Children, Adolescents and Young Adults: In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients, and over 4,400 pediatric patients, the incidence of suicidal thoughts and behaviors in patients 24 years of age and younger was greater in antidepressant-treated patients than in placebo-treated patients. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1000 patients treated are provided in Table 6.
No suicides occurred in any of the pediatric studies. There were suicides in the adult studies, but the number was not sufficient to reach any conclusion about antidepressant drug effect on suicide. (See Table 6.)

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It is unknown whether the risk of suicidal thoughts and behaviors in children, adolescents, and young adults extends to longer-term use, i.e., beyond four months. However, there is substantial evidence from placebo-controlled maintenance studies in adults with MDD that antidepressants delay the recurrence of depression.
Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy and at times of dosage changes. Consider changing the therapeutic regimen, including possibly discontinuing Brexpiprazole (Rexulti), in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.
As with other products of this class, suicidal ideation and attempt have been reported during use of brexpiprazole.
Cerebrovascular Adverse Reactions Including Stroke in Elderly Patients with Dementia-Related Psychosis: In placebo-controlled trials in elderly subjects with dementia, patients randomized to risperidone, aripiprazole, and olanzapine had a higher incidence of stroke and transient ischemic attack, including fatal stroke. Brexpiprazole (Rexulti) is not approved for the treatment of patients with dementia-related psychosis without agitation associated with dementia due to Alzheimer's disease [see Warnings and Increased Mortality in Elderly Patients with Dementia-Related Psychosis previously].
Neuroleptic Malignant Syndrome (NMS): Neuroleptic Malignant Syndrome (NMS), a potentially fatal symptom complex, has been reported in association with administration of antipsychotic drugs, including Brexpiprazole (Rexulti).
Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia). Additional signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
If NMS is suspected, immediately discontinue Brexpiprazole (Rexulti) and provide intensive symptomatic treatment and monitoring.
Tardive Dyskinesia: Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs. The risk appears to be highest among elderly, especially elderly women, but it is impossible to predict which patients will develop the syndrome. Whether antipsychotic drugs differ in their potential to cause tardive dyskinesia is unknown.
The risk of tardive dyskinesia and the likelihood that it will become irreversible appear to increase as the duration of treatment and the total cumulative dose increases. The syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. It may also occur after discontinuation of treatment.
Tardive dyskinesia may remit, partially or completely, if antipsychotic treatment is discontinued. Antipsychotic treatment, itself may suppress (or partially suppress) the signs and symptoms of the syndrome and thereby may possibly mask the underlying process. The effect that symptomatic suppression has upon the long-term course of tardive dyskinesia is unknown.
Given these considerations, Brexpiprazole (Rexulti) should be prescribed in a manner that is most likely to reduce the occurrence of tardive dyskinesia. Chronic antipsychotic treatment should generally be reserved for patients who appear to suffer from a chronic illness that (1) is known to respond to antipsychotic drugs, and (2) for whom alternative, equally effective, but potentially less harmful treatments are not available or appropriate. In patients who do require chronic treatment, the smallest dose and the shortest duration of treatment needed to produce a satisfactory clinical response. The need for continued treatment should be reassessed periodically.
If signs and symptoms of tardive dyskinesia appear in a patient treated with Brexpiprazole (Rexulti), drug discontinuation should be considered. However, some patients may require treatment with Brexpiprazole (Rexulti) despite the presence of the syndrome.
Metabolic Changes: Atypical antipsychotic drugs including Brexpiprazole (Rexulti) have caused metabolic changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and body weight gain. Although all of the drugs in the class to date have been shown to produce some metabolic changes, each drug has its own specific risk profile.
Hyperglycemia and Diabetes Mellitus: Hyperglycemia and diabetes mellitus, in some cases extreme and associated with diabetic ketoacidosis or hyperosmolar coma or death, have been reported in patients treated with atypical antipsychotics. There have been reports of hyperglycemia in patients treated with Brexpiprazole (Rexulti) [see Clinical Trials Experience under Adverse Reactions]. Assess fasting plasma glucose before or soon after initiation of antipsychotic medication, and monitor periodically during long-term treatment.
Adjunctive Treatment of Major Depressive Disorder: In the 6-week, placebo-controlled, fixed-dose clinical studies in patients with MDD, the proportions of patients with shifts in fasting glucose from normal (<100 mg/dL) to high (≥126 mg/dL) and borderline (≥100 mg/dL and <126 mg/dL) to high were similar in patients treated with Brexpiprazole (Rexulti) and placebo.
In the long-term, open-label depression studies, 5% of adult patients with normal baseline fasting glucose experienced a shift to high while taking Brexpiprazole (Rexulti)+Antidepressant (ADT); 25% of subjects with borderline fasting glucose experienced shifts to high. Combined, 9% of subjects with normal or borderline fasting glucose experienced shifts to high fasting glucose during the long-term depression studies.
Schizophrenia: Adult: In the 6-week, placebo-controlled, fixed-dose clinical studies in adult patients with schizophrenia, the proportions of patients with shifts in fasting glucose from normal (<100 mg/dL) to high (≥126 mg/dL) and borderline (≥100 mg/dL and <126 mg/dL) to high were similar in patients treated with Brexpiprazole (Rexulti) and placebo.
In the long-term, open-label schizophrenia studies, 8% of adult patients with normal baseline fasting glucose experienced a shift from normal to high while taking Brexpiprazole (Rexulti), 17% of subjects with borderline fasting glucose experienced shifts from borderline to high. Combined, 10% of subjects with normal or borderline fasting glucose experienced shifts to high fasting glucose during the long-term schizophrenia studies.
Pediatric Patients (13 to 17 years of age): In the long-term, open-label study in pediatric patients with schizophrenia, 2.7% of pediatric patients with normal baseline fasting glucose experienced a shift from normal (<100 mg/dL) to high (≥126 mg/dL) while taking Brexpiprazole (Rexulti).
Agitation Associated with Dementia Due to Alzheimer's Disease: In the 12-week placebo-controlled, fixed-dose studies in patients (51 to 90 years of age) with agitation associated with dementia due to Alzheimer's disease, the proportions of patients with shifts in fasting glucose from normal (<100 mg/dL) to high (≥126 mg/dL) or impaired (≥100 and <126 mg/dL) to high were similar in patients treated with Brexpiprazole (Rexulti) (14%) and patients treated with placebo (16%).
Of the patients who were previously treated with Brexpiprazole (Rexulti) for 12-weeks and continued into a 12-week, active-treatment extension study, 15% of patients with normal baseline fasting glucose experienced a shift from normal (<100 mg/dL) to high (≥126 mg/dL) fasting glucose while taking Brexpiprazole (Rexulti); 30% of patients with impaired fasting glucose experienced shifts from impaired fasting glucose (≥100 and <126 mg/dL) to high fasting glucose. Combined, 20% of patients with normal or impaired fasting glucose experienced shifts to high fasting glucose.
Dyslipidemia: Atypical antipsychotics cause adverse alterations in lipids. Before or soon after initiation of antipsychotic medication, obtain a sating lipid profile at baseline and monitor periodically during treatment. Clinical monitoring of fasting lipid profile at baseline and during treatment is recommended.
Adjunctive Treatment of Major Depressive Disorder: In the 6-week, placebo-controlled, fixed-dose clinical studies in patients with MDD, changes in fasting total cholesterol, LDL cholesterol, and HDL cholesterol were similar in Brexpiprazole (Rexulti)- and placebo-treated patients. Table 7 shows the proportions of patients with changes in fasting triglycerides. (See Table 7.)

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In the long-term, open-label depression studies, shifts in baseline fasting cholesterol from normal to high were reported in 9% (total cholesterol), 3% (LDL cholesterol), and shifts in baseline from normal to low were reported in 14% (HDL cholesterol) of patients taking Brexpiprazole (Rexulti). Of patients with normal baseline triglycerides, 17% experienced shifts to high, and 0.2% experienced shifts to very high. Combined, 0.6% of subjects with normal or borderline fasting triglycerides experienced shifts to very high fasting triglycerides during the long-term depression studies.
Schizophrenia: Adult: In the 6-week, placebo-controlled, fixed-dose clinical studies in patients with schizophrenia, changes in fasting total cholesterol, LDL cholesterol, and HDL cholesterol were similar in Brexpiprazole (Rexulti)- and placebo-treated patients. Table 8 shows the proportions of patients with changes in fasting triglycerides. (See Table 8.)

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In the long-term, open-label schizophrenia studies, shifts in baseline fasting cholesterol from normal to high were reported in 6% (total cholesterol), 2% (LDL cholesterol), and shifts in baseline from normal to low were reported in 17% (HDL cholesterol) of patients taking Brexpiprazole (Rexulti). Of patients with normal baseline triglycerides, 13% experienced shifts to high, and 0.4% experienced shifts to very high triglycerides. Combined, 0.6% of subjects with normal or borderline fasting triglycerides experienced shifts to very high fasting triglycerides during the long-term schizophrenia studies.
Pediatric Patients (13 to 17 years of age): In the long-term, open-label study in pediatric patients with schizophrenia, shifts in baseline fasting total cholesterol from normal to high (<170 to ≥200 mg/dL) were reported in 7% of patients taking Brexpiprazole (Rexulti) and shifts in baseline HDL cholesterol from normal baseline triglycerides, 8.5% experienced shifts from normal to high (<150 to ≥200 mg/dL).
Agitation Associated with Dementia Due to Alzheimer's Disease: In the 12-week placebo-controlled, fixed-dose clinical studies in patients (55 to 90 years of age) with agitation associated with dementia due to Alzheimer's disease, changes in total cholesterol, LDL cholesterol, and HDL cholesterol were similar in Brexpiprazole (Rexulti) and placebo-treated patients.
Table 9 shows the proportions of patients with changes in fasting triglycerides in Brexpiprazole (Rexulti) and placebo-treated patients. (See Table 9.)

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Of the patients who were previously treated with Brexpiprazole (Rexulti) for 12 weeks and continued into a 12-week, active-treatment extension study, 9% of patients taking Brexpiprazole (Rexulti) showed shifts in baseline fasting total cholesterol from normal (<200 mg/dL) to high (≥240 mg/dL), and 16% of patients taking Brexpiprazole (Rexulti) showed shifts in baseline HDL cholesterol from normal to low (≥40 to <40 mg/dL). Of the patients with normal baseline triglycerides, 18% experienced shifts from normal (<150 mg/dL) to high (200 to <500 mg/dL).
Weight Gain: Weight gain has been observed in patients treated with atypical antipsychotics including Brexpiprazole (Rexulti). Monitor weight at baseline and frequently thereafter.
Adjunctive Treatment of Major Depressive Disorder: Table 10 shows weight gain data at last visit and percentage of adult patients with ≥7% increase in body weight at endpoint from the 6-week, placebo-controlled, fixed-dose clinical studies in patients with MDD. (See Table 10.)

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In the long-term, open-label depression studies, 4% of patients discontinued due to weight increase. Brexpiprazole (Rexulti) was associated with mean change from baseline in weight of 2.9 kg at week 26 and 3.1 kg at week 52. In the long-term, open label depression studies, 30% of patients demonstrated a ≥7% increase in body weight and 4% demonstrated a ≥7% decrease in body weight.
Schizophrenia: Adult: Table 11 shows weight gain data at last visit and percentage of adult patients with ≥7% increase in body weight at endpoint from the 6-week, placebo-controlled, fixed-dose clinical studies in patients with schizophrenia. (See Table 11.)

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In the long-term, open-label schizophrenia studies, 0.6% of patients discontinued due to weight increase. Brexpiprazole (Rexulti) was associated with mean change from baseline in weight of 1.3 kg at week 26 and 2.0 kg at week 52. In the long-term, open label schizophrenia studies, 20% of patients demonstrated a ≥7% increase in body weight and 10% demonstrated a ≥7% decrease in body weight.
Pediatric Patients (13 to 17 years of age): In the long-term, open label study in pediatric patients with schizophrenia, 0.5% of patients discontinued due to weight increase. The mean increase in weight from the open-label study baseline to last visit was 3.8 kg. To adjust for normal growth, z-scores were derived (measured in standard deviations [SD]), which normalize for natural growth of children and adolescents by comparisons to age- and gender-matched population standards. A z score change <0.5 SD is considered not clinically significant. In this trial, the mean change in z-score from open-label baseline to last visit was 0.10 SD for body weight, while 20% of patients had an increase in age-and-gender-adjusted body weight z-score of at least 0.5 SD from baseline. When treating pediatric, weight gain should be monitored and assessed against that expected for normal growth.
Agitation Associated with Dementia Due to Alzheimer's Disease: In the 12-week placebo-controlled, fixed-dose clinical studies in patients (51 to 90 years of age) with agitation associated with dementia due to Alzheimer's disease, the proportion of the patients with a ≥7% increase in body weight (kg) at any visit were 2% in Brexpiprazole (Rexulti) compared to 0% in placebo group.
In patients who were previously treated with Brexpiprazole (Rexulti) for 12 weeks and who continued into a 12-week, active-treatment extension study, there was no mean change in weight (kg) from baseline to last visit in association with Brexpiprazole (Rexulti). In this extension study, 4% of patients demonstrated ≥7% increase in body weight, and 5% demonstrated a ≥7% decrease in body weight from baseline to last visit.
Pathological Gambling and Other Compulsive Behaviors: Post-marketing case reports suggest that patients can experience intense urges, particularly for gambling, and the inability to control these urges while taking Brexpiprazole (Rexulti). Other compulsive urges, reported less frequently, include: sexual urges, shopping, eating or binge eating, and other impulsive or compulsive behaviors. Because patients may not recognize these behaviors as abnormal, it is important for prescribers to ask patients or their caregivers specifically about the development of new or intense gambling urges, compulsive sexual urges, compulsive shopping, binge or compulsive eating, or other urges while being treated with Brexpiprazole (Rexulti). In some cases, although not all, urges were reported to have stopped when the dose was reduced or the medication was discontinued. Compulsive behaviors may result in harm to the patient and others if not recognized. Consider dose reduction or stopping the medication if a patient develops such urges.
Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia and neutropenia have been reported treatment of antipsychotic agents. Agranulocytosis (including fatal cases) has been reported with other agents in this class.
Possible risk factors for leukopenia/neutropenia include pre-existing low white blood cell count (WBC)/absolute neutrophil count (ANC) and history of drug-induced leukopenia/neutropenia. In patients with a history of a clinically significant low WBC/ANC or drug-induced leukopenia/neutropenia, perform a complete blood count (CBC) frequently during the first few months of therapy. In such patients, consider discontinuation of Brexpiprazole (Rexulti) at the first sign of a clinically significant decline in WBC in the absence of other causative factors.
Monitor patients with clinically significant neutropenia for fever or other symptoms or signs of infection and treat promptly if such symptoms or signs occur. Discontinue Brexpiprazole (Rexulti) in patients with severe neutropenia (absolute neutrophil count <1000/mm³) and follow their WBC until recovery.
Orthostatic Hypotension and Syncope: Atypical antipsychotics cause orthostatic hypotension and syncope. Generally, the risk is greatest during initial dose titration and when increasing the dose. In the short-term, placebo-controlled clinical studies of Brexpiprazole (Rexulti)+ADT in patients with MDD, the incidence of orthostatic hypotension-related adverse reactions in Brexpiprazole (Rexulti)+ADT-treated patients compared to placebo+ADT patients included: dizziness (2% vs. 2%) and orthostatic hypotension (0.1% vs. 0%). In the short-term, placebo-controlled clinical studies of Brexpiprazole (Rexulti) in patients with schizophrenia, the incidence of orthostatic hypotension-related adverse reactions in Brexpiprazole (Rexulti)-treated patients compared to placebo patients included: dizziness (2% versus 2%), orthostatic hypotension (0.4% versus 0.2%), and syncope (0.1% versus 0%). In 12-week, placebo-controlled clinical studies of Brexpiprazole (Rexulti) in patients with agitation associated with dementia due to Alzheimer's disease, the incidence of orthostatic hypotension-related adverse reactions in patients treated with Brexpiprazole (Rexulti) compared to patients treated with placebo included: dizziness (3% versus 3%), orthostatic hypotension (1% versus 1%), and syncope (0.2% versus 0.8%).
Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension, (e.g., elderly patients, patients with dehydration, hypovolemia, concomitant treatment with antihypertensive medication), patients with known cardiovascular disease (history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), and patients with cerebrovascular disease. Brexpiprazole (Rexulti) has not been evaluated in patients with a recent history of myocardial infarction or unstable cardiovascular disease. Such patients were excluded from pre-marketing clinical studies.
Falls: Antipsychotics, including Brexpiprazole (Rexulti), may cause somnolence, postural hypotension, motor, and sensory instability, which may lead to falls and, consequently, fractures or other injuries. For patients with diseases, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy.
Seizures: Like other antipsychotic drugs, Brexpiprazole (Rexulti) should be used cautiously in patients with a history of seizures or with conditions that potentially lower the seizure threshold. Seizures have been reported during use of brexpiprazole. Conditions that lower the seizure threshold may be more prevalent in older patients.
Body Temperature Dysregulation: Atypical antipsychotics may disrupt the body's ability to reduce core body temperature. Strenous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature, use Brexpiprazole (Rexulti) with caution in patients who may experience these conditions.
Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. Antipsychotic drugs, including Brexpiprazole (Rexulti), should be used cautiously in patients at risk for aspiration.
Potential for Cognitive and Motor Impairment: Brexpiprazole (Rexulti), like other antipsychotics, has the potential to impair judgment, thinking, or motor skills. In 6-week, placebo-controlled clinical studies in patients with MDD, somnolence (including sedation and hypersomnia) was reported in 4% for Brexpiprazole (Rexulti)+ADT-treated patients compared to 1% of placebo+ADT patients.
In 6-week, placebo-controlled clinical studies in patients with schizophrenia, somnolence (including sedation and hypersomnia) was reported in 5% of Brexpiprazole (Rexulti)-treated patients compared to 3% of placebo-treated patients.
In the 12-week placebo-controlled, fixed-dose clinical studies in patients (51 to 90 years of age) with agitation associated with dementia due to Alzheimer's disease, somnolence (including sedation) was reported in 3% of patients treated with Brexpiprazole (Rexulti) compared to 1% of patients treated with placebo.
Patients should be cautioned about operating hazardous machinery, including motor vehicles, until they are reasonably certain that Brexpiprazole (Rexulti) therapy does not affect them adversely.
Prolactin: Brexpiprazole (Rexulti) can elevate prolactin levels. Elevations associated with brexpiprazole treatment are generally mild and may decline during administration, however, in some infrequent cases the effect may persist during administration.
CYP2D6 Poor Metabolizers: Dosage adjustment is recommended in known CYP2D6 poor metabolizers, because these patients have higher brexpiprazole concentrations than normal metabolizers of CYP2D6. Approximately 8% of Caucasians and 3-8% of Black/African Americans cannot metabolize CYP2D6 substrates and are classified as poor metabolizers (PM) [see Recommended Dosage in Patients with Hepatic Impairment under Dosage and Administration, Pharmacology: Pharmacokinetics under Actions].
Hepatic Impairment: The maximum recommended dosage in patients with moderate to severe hepatic impairment (Child-Pugh score ≥7) is lower than those with mild hepatic impairment and those with normal hepatic function [see Recommended Dosage for Agitation Associated with Dementia Due to Alzheimer's Disease under Dosage & Administration]. Patients with moderate to severe hepatic impairment generally had higher exposure to brexpiprazole than patients with normal hepatic function [see Pharmacology: Pharmacokinetics under Actions]. Greater exposure may increase the risk of Brexpiprazole (Rexulti)-associated adverse reactions.
Renal Impairment: The maximum recommended dosage in patients with CrCl <60 mL/minute is lower than those with mild renal impairment and those with normal renal function [see Dosage Adjustments for Renal Impairment under Dosage & Administration]. Patients with renal impairment had higher exposure to brexpiprazole than patients with normal renal function [see Pharmacology: Pharmacokinetics under Actions]. Greater exposure may increase the risk of Brexpiprazole (Rexulti)-associated adverse reactions.
Other Specific Populations: The recommended dosage for Brexpiprazole (Rexulti) is the same in males and females, in different racial groups, and in smokers and nonsmokers [see Pharmacology: Pharmacokinetics under Actions].
Drug Abuse and Dependence: Controlled Substance: Brexpiprazole (Rexulti) is not a controlled substance.
Abuse: Animals given access to Brexpiprazole (Rexulti) did not self-administer the drug, suggesting that Brexpiprazole (Rexulti) does not have rewarding properties.
Dependence: Humans and animals that received chronic Brexpiprazole (Rexulti) administration did not demonstrate any withdrawal signs upon drug discontinuation. This suggests that Brexpiprazole (Rexulti) does not produce physical dependence.
Use in Children: Schizophrenia: Safety and effectiveness of Brexpiprazole (Rexulti) for treatment of schizophrenia have been established in pediatric patients 13 years of age and older. Use of Brexpiprazole (Rexulti) in this population is supported by evidence from adequate and well-controlled studies in adults with schizophrenia, pharmacokinetic data from adults and pediatric patients, and safety data in pediatric patients 13 to 17 years of age [see Metabolic Changes as mentioned previously, Clinical Trials Experience under Adverse Reactions & Pharmacology: Pharmacokinetics under Actions].
Major Depressive Disorder: Safety and effectiveness in pediatric patients have not been established. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric patients [see Warnings, Suicidal Thoughts and Behaviors in Children Adolescents and Young Adults under Precautions].
Use in the Elderly: Antipsychotic drugs increase the risk of death in elderly patients with dementia-related psychosis. Brexpiprazole (Rexulti) is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Increased Mortality in Elderly Patients with Dementia-Related Psychosis previously].
Adjunctive Treatment of Major Depressive Disorder (MDD) and Schizophrenia: Of the total number of Brexpiprazole (Rexulti)-treated patients in the clinical studies for the adjunctive therapy to antidepressants for MDD and for schizophrenia, 248 (3%) were 65 years of age and older (which included 45 (18%) patients who were 75 years of age and older). Clinical studies of Brexpiprazole (Rexulti) in these patients did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients. In general, dosage selection for the treatment of MDD or schizophrenia in a geriatric patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, and cardiac function, concomitant diseases, and other drug therapy.
Agitation Associated with Dementia Due to Alzheimer's Disease: The total number of Brexpiprazole (Rexulti)-treated patients 65 years of age and older in the clinical studies for agitation associated with dementia due to Alzheimer's disease (Studies 6 and 7) was 448 (86%) including 170 (33%) patients 65 to 74 years of age, 228 (44%) patients 75 to 84 years of age, and 50 (10%) patients 85 years of age and older [see Pharmacology: Pharmacodynamics: Clinical Studies: Agitation Associated with Dementia Due to Alzheimer's Disease under Actions].
In clinical studies of Brexpiprazole (Rexulti) for the treatment of agitation associated with dementia due to Alzheimer's disease did not include sufficient numbers of younger adult patients to determine if patients 65 years of age and older respond differently than younger adult patients.