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 * Select Your Indication
    * Adjunctive MDD
   
    * Bipolar I Depression
   
    * Bipolar I Acute Manic or Mixed Episodes
   
    * Schizophrenia

 * Efficacy
    * Adjunctive MDD
   
    * Bipolar I Depression
   
    * Bipolar I Acute Manic or Mixed Episodes
   
    * Schizophrenia

 * Tolerability & Safety
    * Adjunctive MDD
   
    * Bipolar I Depression
   
    * Bipolar I Acute Manic or Mixed Episodes
   
    * Schizophrenia

 * Pharmacology
    * Mechanism of Action
   
    * Pharmacodynamics
   
    * Pharmacokinetics

 * Dosing
 * Savings & Support
    * Savings & Resources
   
    * Formulary Coverage

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    * Adjunctive MDD
   
    * Bipolar I Depression
   
    * Bipolar I Acute Manic or Mixed Episodes
   
    * Schizophrenia

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FDA APPROVED

FOR ADJUNCTIVE THERAPY TO ANTIDEPRESSANTS FOR THE TREATMENT OF MAJOR DEPRESSIVE
DISORDER (MDD) IN ADULTS


THE POWER OF BOTH


PROVEN EFFICACY WELL-ESTABLISHED TOLERABILITY



WHEN ADDED TO AN ANTIDEPRESSANT IN ADULT
PATIENTS WITH MDD, VRAYLAR DELIVERS:

THE POWER OF BOTH

When added to an antidepressant in adult patients with MDD,
VRAYLAR delivers THE POWER OF BOTH:


PROVEN EFFICACY1


IN 6- AND 8-WEEK TRIALS, VRAYLAR + ANTIDEPRESSANT DEMONSTRATED

 * Reduction in overall depressive symptoms*†
 * Relief at lowest dose of 1.5 mg/day*†
 * Flexibility to increase to 3 mg/day at day 15*†

View MDD Efficacy


WELL-ESTABLISHED TOLERABILITY1‡


IN 6- AND 8-WEEK TRIALS, VRAYLAR + ANTIDEPRESSANT DEMONSTRATED

 * Mean weight change of <2 lb1§
 * Metabolic shifts similar to placebo for total cholesterol and fasting
   triglycerides||
 * 97% of patients did not have a clinically meaningful increase in blood
   glucose¶

View MDD Tolerability & Safety

*In a 6-week, placebo-controlled trial, mean change from baseline in MADRS total
score at 6 weeks: VRAYLAR 1.5 mg/day + ADT (n=250): -14.1 (baseline mean: 32.8,
P=0.0050); VRAYLAR 3 mg/day + ADT (n=252): -13.1 (baseline mean: 32.7,
P=0.0727); placebo + ADT (n=249): -11.5 (baseline mean: 31.9).1,2

†In an 8-week, placebo-controlled trial, mean change from baseline in MADRS
total score at 8 weeks: VRAYLAR 1 -2 mg/day + ADT (n=273): -13.4 (baseline mean:
29.0, P=0.2404); VRAYLAR 2 -4.5 mg/day + ADT (n=271): -14.6 (baseline mean:
29.3, P=0.0114); placebo + ADT (n=264): -12.5 (baseline mean: 28.9).1,2

‡The most common adverse reactions observed in the two 6-week MDD studies (≥5%
and at least twice the rate of placebo) were akathisia, nausea, and insomnia. In
the 6-week studies, 4% of the patients who received VRAYLAR discontinued
treatment due to an adverse reaction, compared with 2% of placebo-treated
patients in these trials.1,4

§Weight gain may occur. In two 6-week MDD studies, 2% of people taking VRAYLAR +
ADT had a weight increase of ≥7% vs 1% of those taking placebo + ADT. The mean
weight changes reported in these studies were VRAYLAR 1.5 mg/day + ADT (n=502) =
+1.54 lb; VRAYLAR 3 mg/day + ADT (n=503) = +1.54 lb; placebo + ADT (n=503) =
+0.44 lb. In the 8-week MDD study, 2.5% of people taking VRAYLAR + ADT had a
weight increase of ≥7% vs 2% of those taking placebo. The mean weight changes
reported in this study were VRAYLAR 1-2 mg/day + ADT (n=273) = +1.98 lb; VRAYLAR
2 -4.5 mg/day + ADT (n=273) = +1.98 lb; placebo + ADT (n=266) = 0 lbs. Monitor
weight at baseline and frequently thereafter.1

||In the 6- and 8-week MDD studies, proportion of patients with metabolic shifts
was similar to placebo. Shift defined as: total cholesterol: normal/borderline
(<240 mg/dL) to high (≥240 mg/dL); fasting triglycerides: normal/borderline
(<200 mg/dL) to high (≥200 mg/dL).1

¶In 6-week studies, the proportion of patients with shifts in fasting glucose
from normal (<100 mg/dL) to high (≥126 mg/dL): VRAYLAR 1.5 mg per day + ADT =
2%; VRAYLAR 3 mg per day + ADT = 3.2%; placebo-treated = 1.3%. The proportion of
patients with shifts in fasting glucose from normal to borderline (≥100 and <126
mg/dL) or from borderline to high was similar in patients treated with VRAYLAR
and placebo. In the 8-week study, the shifts in fasting glucose were similar
among the VRAYLAR and placebo + ADT groups.1


ADT=antidepressant therapy; MADRS=Montgomery-Asberg Depression Rating Scale;
MDD=major depressive disorder. 

--------------------------------------------------------------------------------


VRAYLAR IS APPROVED ACROSS 4 INDICATIONS1



Evaluated in 12 clinical trials1#

~6,700 clinical trial patients1

~7 years of real-world experience1

More than 100,000 clinicians have prescribed VRAYLAR2**

#The most common adverse reactions observed in VRAYLAR trials (≥5% and at least
twice the rate of placebo): major depressive disorder (two 6-week studies)
(VRAYLAR 1.5 mg/day + ADT or 3 mg/day + ADT vs placebo + ADT)—akathisia (7%, 10%
vs 2%), nausea (7%, 6% vs 3%), and insomnia (9%, 10% vs 5%); bipolar I
depression (VRAYLAR 1.5 mg/day or 3 mg/day vs placebo)—nausea (7%, 7% vs 3%),
akathisia (6%, 10% vs 2%), restlessness (2%, 7% vs 3%), and EPS (4%, 6% vs 2%);
bipolar I mania (VRAYLAR 3-6 mg/day vs placebo)—EPS (26% vs 12%), akathisia (20%
vs 5%), vomiting (10% vs 4%), dyspepsia (7% vs 4%), somnolence (7% vs 4%), and
restlessness (7% vs 2%); schizophrenia (VRAYLAR 1.5-3 mg/day and 4.5-6 mg/day vs
placebo)—EPS (15%, 19% vs 8%) and akathisia (9%, 13% vs 4%).1

**Inclusive of all indications.

ADT=antidepressant therapy; EPS=extrapyramidal symptoms.


VRAYLAR SAVINGS AND SUPPORT

VRAYLAR has #1 unrestricted commercial access among branded oral atypical
antipsychotics.2*†‡
 


VRAYLAR ACCESS
 

 * 100% Medicare Part D coverage2
 * 94% National Commercial coverage2

*Excluding branded products that have available generics.


†Unrestricted access is defined as a product covered on formulary that does not
require a prior authorization and/or step therapy.

‡As of July 2023. Applicable to the atypical antipsychotic market basket.
Coverage requirements and benefit designs vary by payer and may change over
time. Please consult with payers directly for the most current reimbursement
policies.
 

Get Started on VRAYLAR



IMPORTANT SAFETY INFORMATION AND INDICATIONS

INDICATIONS AND USAGE

VRAYLAR (cariprazine) is indicated in adults as adjunctive therapy to
antidepressants for the treatment of major depressive disorder (MDD), for the
treatment of depressive episodes associated with bipolar I disorder (bipolar
depression), for the acute treatment of manic or mixed episodes associated with
bipolar I disorder, and for the treatment of schizophrenia.


IMPORTANT SAFETY INFORMATION


WARNINGS: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS AND SUICIDAL THOUGHTS AND BEHAVIORS

 * Elderly patients with dementia-related psychosis treated with antipsychotic
   drugs are at an increased risk of death. VRAYLAR is not approved for
   treatment of patients with dementia-related psychosis.
 * Antidepressants increased the risk of suicidal thoughts and behaviors in
   pediatric and young adult patients in short-term studies. Closely monitor
   antidepressant-treated patients for clinical worsening, and for emergence of
   suicidal thoughts and behaviors. Safety and effectiveness of VRAYLAR have not
   been established in pediatric patients.

Contraindication: VRAYLAR is contraindicated in patients with known
hypersensitivity. Reactions have included rash, pruritus, urticaria, and
reactions suggestive of angioedema.

Cerebrovascular Adverse Reactions, Including Stroke: In clinical trials with
antipsychotic drugs, elderly patients with dementia had a higher incidence of
cerebrovascular adverse reactions, including fatalities, vs placebo. VRAYLAR is
not approved for the treatment of patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS): NMS, a potentially fatal symptom complex,
has been reported with antipsychotic drugs. NMS may cause hyperpyrexia, muscle
rigidity, delirium, and autonomic instability. Additional signs may include
elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal
failure. Manage with immediate discontinuation, intensive symptomatic treatment,
and monitoring.

Tardive Dyskinesia (TD): Risk of developing TD (a syndrome of potentially
irreversible, involuntary, dyskinetic movements) and the likelihood it will
become irreversible may increase with the duration of treatment and the
cumulative dose. The syndrome can develop after a relatively brief treatment
period, even at low doses, or after treatment discontinuation. If signs and
symptoms of TD appear, drug discontinuation should be considered.

Late-Occurring Adverse Reactions: Adverse reactions may first appear several
weeks after initiation of VRAYLAR, probably because plasma levels of cariprazine
and its major metabolites accumulate over time. As a result, the incidence of
adverse reactions in short-term trials may not reflect the rates after
longer-term exposures. Monitor for adverse reactions, including extrapyramidal
symptoms (EPS) or akathisia, and patient response for several weeks after
starting VRAYLAR and after each dosage increase. Consider reducing the dose or
discontinuing the drug.

Metabolic Changes: Atypical antipsychotics, including VRAYLAR, have caused
metabolic changes, such as:

 * Hyperglycemia and Diabetes Mellitus: Hyperglycemia, in some cases associated
   with ketoacidosis, hyperosmolar coma, or death, has been reported in patients
   treated with atypical antipsychotics. Assess fasting glucose before or soon
   after initiation of treatment, and monitor periodically during long-term
   treatment.
 * Dyslipidemia: Atypical antipsychotics cause adverse alterations in lipids.
   Before or soon after starting an antipsychotic, obtain baseline fasting lipid
   profile and monitor periodically during treatment.
 * Weight Gain: Weight gain has been observed with VRAYLAR. Monitor weight at
   baseline and frequently thereafter.

Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia/neutropenia have been
reported with antipsychotics, including VRAYLAR. Agranulocytosis (including
fatal cases) has been reported with other antipsychotics. Monitor complete blood
count in patients with pre-existing low white blood cell count (WBC)/absolute
neutrophil count or history of drug-induced leukopenia/neutropenia. Discontinue
VRAYLAR at the first sign of a clinically significant decline in WBC and in
severely neutropenic patients.

Orthostatic Hypotension and Syncope: Atypical antipsychotics cause orthostatic
hypotension and syncope, with the greatest risk during initial titration and
with dose increases. Monitor orthostatic vital signs in patients predisposed to
hypotension and in those with cardiovascular/cerebrovascular diseases.

Falls: VRAYLAR 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
antipsychotics and recurrently for patients on long-term therapy.

Seizures: Use VRAYLAR with caution in patients with a history of seizures or
with conditions that lower the seizure threshold.

Potential for Cognitive and Motor Impairment: Somnolence was reported with
VRAYLAR. Caution patients about performing activities requiring mental alertness
(eg, operating hazardous machinery or a motor vehicle).

Body Temperature Dysregulation: Use VRAYLAR with caution in patients who may
experience conditions that increase body temperature (eg, strenuous exercise,
extreme heat, dehydration, or concomitant anticholinergics).

Dysphagia: Esophageal dysmotility and aspiration have been associated with
antipsychotics. Antipsychotic drugs, including VRAYLAR, should be used
cautiously in patients at risk for aspiration.

Drug Interactions: Strong CYP3A4 inhibitors increase VRAYLAR concentrations, so
VRAYLAR dose reduction is recommended. Concomitant use with CYP3A4 inducers is
not recommended.

Adverse Reactions: The most common adverse reactions in clinical trials ( 5% and
at least twice the rate of placebo) are listed below:

 * Adjunctive treatment of Major Depressive Disorder:
   * In 6-week, fixed-dose trials the incidences within the recommended doses
     (VRAYLAR 1.5 mg/day + antidepressant therapy [ADT] or 3 mg/day + ADT vs
     placebo + ADT) were akathisia (7%, 10% vs 2%), nausea (7%, 6% vs 3%), and
     insomnia (9%, 10% vs 5%).
   * In one 8-week flexible-dose trial, incidences within the doses (VRAYLAR 1-2
     mg/day + antidepressant therapy [ADT] or 2-4.5 mg/day+ ADT vs placebo +
     ADT) were akathisia (8%, 23% vs 3%), restlessness (8%, 8% vs 3%), fatigue
     (7%, 10% vs 4%), constipation (2%, 5% vs 2%), nausea (7%, 13% vs 5%),
     increased appetite (2%, 5% vs 2%), dizziness (4%, 5% vs 2%), insomnia (14%,
     16% vs 8%), and extrapyramidal symptoms (12%, 18% vs 5%).
 * Bipolar Mania: The incidences within the recommended dose range (VRAYLAR 3–6
   mg/day vs placebo) were EPS (26% vs 12%), akathisia (20% vs 5%), vomiting
   (10% vs 4%), dyspepsia (7% vs 4%), somnolence (7% vs 4%), and restlessness
   (7% vs 2%).
 * Bipolar Depression: The incidences within the recommended doses (VRAYLAR 1.5
   mg/day or 3 mg/day vs placebo) were nausea (7%, 7% vs 3%), akathisia (6%, 10%
   vs 2%), restlessness (2%, 7% vs 3%), and EPS (4%, 6% vs 2%).
 * Schizophrenia: The incidences within the recommended dose range (VRAYLAR
   1.5–3 mg/day and 4.5–6 mg/day vs placebo) were EPS (15%, 19% vs 8%) and
   akathisia (9%, 13% vs 4%).

US-VRA-220402

Please also see full Prescribing Information, including Boxed Warnings.

 * Important Safety Information
 * Full Prescribing Information
 * About AbbVie
 * References
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 * Accessibility Statement
 * Contact Us
 * Terms of Use
 * Privacy Notice
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 * Your Privacy Choices

If you are a patient, and have any questions, please discuss them with your
doctor or healthcare provider.

For additional information about VRAYLAR®, call AbbVie Medical Information
toll-free at 1.800.678.1605.

Licensed from Gedeon Richter Plc.

© 2023 AbbVie. All rights reserved. 
VRAYLAR® and its design are trademarks of Allergan Pharmaceuticals International
Limited, an AbbVie company.
VRAYPAYSM is a service mark of Forest Laboratories Holdings Ltd., an AbbVie
company.

US-VRAA-230248










WARNINGS: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS

 * Elderly patients with dementia-related psychosis treated with antipsychotic
   drugs are at an increased risk of death. VRAYLAR is not approved for
   treatment of patients with dementia-related psychosis.
 * Antidepressants increased the risk of suicidal thoughts and behaviors in
   pediatric and young adult patients in short-term studies. Closely monitor
   antidepressant-treated patients for clinical worsening, and for emergence of
   suicidal thoughts and behaviors.

WARNINGS: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS

 * Elderly patients with dementia-related psychosis treated with antipsychotic
   drugs are at an increased risk of death. VRAYLAR is not approved for
   treatment of patients with dementia-related psychosis.

WARNINGS: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS

 * Elderly patients with dementia-related psychosis treated with antipsychotic
   drugs are at an increased risk of death. VRAYLAR is not approved for
   treatment of patients with dementia-related psychosis.
 * Antidepressants increased the risk of suicidal thoughts and behaviors in
   pediatric and young adult patients in short-term studies. Closely monitor
   antidepressant-treated patients for clinical worsening, and for emergence of
   suicidal thoughts and behaviors.

WARNINGS: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS

 * Elderly patients with dementia-related psychosis treated with antipsychotic
   drugs are at an increased risk of death. VRAYLAR is not approved for
   treatment of patients with dementia-related psychosis.


IMPORTANT SAFETY INFORMATION AND INDICATIONS

INDICATIONS AND USAGE

VRAYLAR (cariprazine) is indicated in adults as adjunctive therapy to
antidepressants for the treatment of major depressive disorder (MDD), for the
treatment of depressive episodes associated with bipolar I disorder (bipolar
depression), for the acute treatment of manic or mixed episodes associated with
bipolar I disorder, and for the treatment of schizophrenia.


IMPORTANT SAFETY INFORMATION


WARNINGS: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS AND SUICIDAL THOUGHTS AND BEHAVIORS

 * Elderly patients with dementia-related psychosis treated with antipsychotic
   drugs are at an increased risk of death. VRAYLAR is not approved for
   treatment of patients with dementia-related psychosis.
 * Antidepressants increased the risk of suicidal thoughts and behaviors in
   pediatric and young adult patients in short-term studies. Closely monitor
   antidepressant-treated patients for clinical worsening, and for emergence of
   suicidal thoughts and behaviors. Safety and effectiveness of VRAYLAR have not
   been established in pediatric patients.

Contraindication: VRAYLAR is contraindicated in patients with known
hypersensitivity. Reactions have included rash, pruritus, urticaria, and
reactions suggestive of angioedema.

Cerebrovascular Adverse Reactions, Including Stroke: In clinical trials with
antipsychotic drugs, elderly patients with dementia had a higher incidence of
cerebrovascular adverse reactions, including fatalities, vs placebo. VRAYLAR is
not approved for the treatment of patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS): NMS, a potentially fatal symptom complex,
has been reported with antipsychotic drugs. NMS may cause hyperpyrexia, muscle
rigidity, delirium, and autonomic instability. Additional signs may include
elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal
failure. Manage with immediate discontinuation, intensive symptomatic treatment,
and monitoring.

Tardive Dyskinesia (TD): Risk of developing TD (a syndrome of potentially
irreversible, involuntary, dyskinetic movements) and the likelihood it will
become irreversible may increase with the duration of treatment and the
cumulative dose. The syndrome can develop after a relatively brief treatment
period, even at low doses, or after treatment discontinuation. If signs and
symptoms of TD appear, drug discontinuation should be considered.

Late-Occurring Adverse Reactions: Adverse reactions may first appear several
weeks after initiation of VRAYLAR, probably because plasma levels of cariprazine
and its major metabolites accumulate over time. As a result, the incidence of
adverse reactions in short-term trials may not reflect the rates after
longer-term exposures. Monitor for adverse reactions, including extrapyramidal
symptoms (EPS) or akathisia, and patient response for several weeks after
starting VRAYLAR and after each dosage increase. Consider reducing the dose or
discontinuing the drug.

Metabolic Changes: Atypical antipsychotics, including VRAYLAR, have caused
metabolic changes, such as:

 * Hyperglycemia and Diabetes Mellitus: Hyperglycemia, in some cases associated
   with ketoacidosis, hyperosmolar coma, or death, has been reported in patients
   treated with atypical antipsychotics. Assess fasting glucose before or soon
   after initiation of treatment, and monitor periodically during long-term
   treatment.
 * Dyslipidemia: Atypical antipsychotics cause adverse alterations in lipids.
   Before or soon after starting an antipsychotic, obtain baseline fasting lipid
   profile and monitor periodically during treatment.
 * Weight Gain: Weight gain has been observed with VRAYLAR. Monitor weight at
   baseline and frequently thereafter.

Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia/neutropenia have been
reported with antipsychotics, including VRAYLAR. Agranulocytosis (including
fatal cases) has been reported with other antipsychotics. Monitor complete blood
count in patients with pre-existing low white blood cell count (WBC)/absolute
neutrophil count or history of drug-induced leukopenia/neutropenia. Discontinue
VRAYLAR at the first sign of a clinically significant decline in WBC and in
severely neutropenic patients.

Orthostatic Hypotension and Syncope: Atypical antipsychotics cause orthostatic
hypotension and syncope, with the greatest risk during initial titration and
with dose increases. Monitor orthostatic vital signs in patients predisposed to
hypotension and in those with cardiovascular/cerebrovascular diseases.

Falls: VRAYLAR 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
antipsychotics and recurrently for patients on long-term therapy.

Seizures: Use VRAYLAR with caution in patients with a history of seizures or
with conditions that lower the seizure threshold.

Potential for Cognitive and Motor Impairment: Somnolence was reported with
VRAYLAR. Caution patients about performing activities requiring mental alertness
(eg, operating hazardous machinery or a motor vehicle).

Body Temperature Dysregulation: Use VRAYLAR with caution in patients who may
experience conditions that increase body temperature (eg, strenuous exercise,
extreme heat, dehydration, or concomitant anticholinergics).

Dysphagia: Esophageal dysmotility and aspiration have been associated with
antipsychotics. Antipsychotic drugs, including VRAYLAR, should be used
cautiously in patients at risk for aspiration.

Drug Interactions: Strong CYP3A4 inhibitors increase VRAYLAR concentrations, so
VRAYLAR dose reduction is recommended. Concomitant use with CYP3A4 inducers is
not recommended.

Adverse Reactions: The most common adverse reactions in clinical trials ( 5% and
at least twice the rate of placebo) are listed below:

 * Adjunctive treatment of Major Depressive Disorder:
   * In 6-week, fixed-dose trials the incidences within the recommended doses
     (VRAYLAR 1.5 mg/day + antidepressant therapy [ADT] or 3 mg/day + ADT vs
     placebo + ADT) were akathisia (7%, 10% vs 2%), nausea (7%, 6% vs 3%), and
     insomnia (9%, 10% vs 5%).
   * In one 8-week flexible-dose trial, incidences within the doses (VRAYLAR 1-2
     mg/day + antidepressant therapy [ADT] or 2-4.5 mg/day+ ADT vs placebo +
     ADT) were akathisia (8%, 23% vs 3%), restlessness (8%, 8% vs 3%), fatigue
     (7%, 10% vs 4%), constipation (2%, 5% vs 2%), nausea (7%, 13% vs 5%),
     increased appetite (2%, 5% vs 2%), dizziness (4%, 5% vs 2%), insomnia (14%,
     16% vs 8%), and extrapyramidal symptoms (12%, 18% vs 5%).
 * Bipolar Mania: The incidences within the recommended dose range (VRAYLAR 3–6
   mg/day vs placebo) were EPS (26% vs 12%), akathisia (20% vs 5%), vomiting
   (10% vs 4%), dyspepsia (7% vs 4%), somnolence (7% vs 4%), and restlessness
   (7% vs 2%).
 * Bipolar Depression: The incidences within the recommended doses (VRAYLAR 1.5
   mg/day or 3 mg/day vs placebo) were nausea (7%, 7% vs 3%), akathisia (6%, 10%
   vs 2%), restlessness (2%, 7% vs 3%), and EPS (4%, 6% vs 2%).
 * Schizophrenia: The incidences within the recommended dose range (VRAYLAR
   1.5–3 mg/day and 4.5–6 mg/day vs placebo) were EPS (15%, 19% vs 8%) and
   akathisia (9%, 13% vs 4%).

US-VRA-220402




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