VRAYLAR® (cariprazine) Dosing Information Skip to Main Content Contact Medical Information Prescribing Information Patient Site Savings Cards Request Samples Speaker Program Request a Rep Indications Adjunctive MDD Overview Bipolar I Overview Schizophrenia Efficacy Adjunctive MDD Bipolar I Depression Bipolar I Acute Manic or Mixed Episodes Schizophrenia Tolerability & Safety Mechanism of Action Dosing Savings & Resources Access Savings Resources VRAYLAR Videos Speaker Program Request a Rep Flexible and convenient dosing Recommended dosing Recommended dosing Dosing adjustments Drug interactions Pharmacokinetics One capsule 1 Once daily 1 With or without food 1 Recommended dosing by indication Adjunctive MDD BP-I depression BP-I manic or mixed Schizophrenia The lowest dose (1.5 mg) is a therapeutic dose as an adjunctive therapy to antidepressants for MDD 1 Recommended dosing 1 1.5 mg/day Lowest and Most Commonly Prescribed Dose 2 * Capsule image is not actual size. Day 1–Start at 1.5 mg/day Day 15–May increase dose to 3 mg/day Depending upon clinical response and tolerability, the dosage can be increased to 3 mg once daily at Day 15 1 Following discontinuation of VRAYLAR, the decline in plasma concentrations of active drug and metabolites may not be immediately reflected in patients’ clinical symptoms 1 In clinical trials, dosage and titration at intervals of less than 14 days resulted in a higher incidence of adverse reactions. Maximum recommended dose is 3 mg once daily. 1 (See adverse reactions from 8-week study in Section 6.1 of the full Prescribing Information ) *Data accessed October 2024. The lowest dose (1.5 mg) is a therapeutic dose for bipolar I depression 1 Bipolar I depression recommended dosing 1 1.5 mg/day Lowest and Most Commonly Prescribed Dose 2 * Capsule image is not actual size. Day 1–Start at 1.5 mg/day Day 15–May increase dose to 3 mg/day Maximum recommended dose is 3 mg/day, depending on clinical response and tolerability. Following discontinuation of VRAYLAR, the decline in plasma concentrations of active drug and metabolites may not be immediately reflected in patients’ clinical symptoms. 1 *Data accessed October 2024. Flexible and convenient dosing Bipolar I acute manic or mixed episodes recommended doses 1 Day 1–Start at 1.5 mg/day Day 2–Increase dose to 3 mg/day Further adjustments can be made in 1.5- or 3-mg/day increments, up to a maximum recommended dose of 6 mg/day, depending on clinical response and tolerability. In short-term controlled studies, doses above 6 mg/day did not confer increased effectiveness sufficient to outweigh dose-related adverse reactions 1 Following discontinuation of VRAYLAR, the decline in plasma concentrations of active drug and metabolites may not be immediately reflected in patients’ clinical symptoms. 1 Flexible and convenient dosing Schizophrenia recommended doses 1 Day 1–Start at 1.5 mg/day Dose can be increased to 3 mg on Day 2 Further adjustments can be made in 1.5- or 3-mg increments, up to a maximum recommended dose of 6 mg/day, depending on clinical response and tolerability. In short-term controlled studies, doses above 6 mg/day did not confer increased effectiveness sufficient to outweigh dose-related adverse reactions 1 Dosing adjustments No dosage adjustment required based on 1 : Mild or moderate hepatic or renal impairment Smoking status Age Race Sex VRAYLAR is not recommended in patients with severe hepatic (Child-Pugh score 10–15) or renal impairment (creatinine clearance <30 mL/min), as it has not been evaluated in these patient populations 1 VRAYLAR can be coadministered with a PPI. It does not affect VRAYLAR exposure at steady state 1 PPI=proton pump inhibitor. Drug interactions VRAYLAR is primarily metabolized by CYP3A4 and to a lesser extent by CYP2D6. 1 CYP3A4 is responsible for the formation and elimination of the major active metabolites in cariprazine. 1 Clinically significant drug interactions and dosage adjustments with VRAYLAR 1 Clinical impact Intervention Strong CYP3A4 inhibitors Initiating strong CYP3A4 inhibitor while on a stable dose of VRAYLAR For patients currently taking VRAYLAR 1.5 or 3 mg once daily, adjust VRAYLAR dosage to 1.5 mg every 3 days For patients currently taking VRAYLAR 4.5 or 6 mg once daily, the VRAYLAR dosage should be reduced to 1.5 mg every other day Initiating VRAYLAR therapy while already on a strong CYP3A4 inhibitor Bipolar I depression and as adjunctive therapy to antidepressants for MDD: VRAYLAR starting dose is 1.5 mg every 3 days Bipolar I acute manic or mixed episodes and schizophrenia: start VRAYLAR at 1.5 mg every 3 days; increase to 1.5 mg every other day, if needed † When a strong or moderate CYP3A4 inhibitor is withdrawn, VRAYLAR dosage may need to be increased † Moderate CYP3A4 inhibitors Initiating moderate CYP3A4 inhibitor while on a stable dose of VRAYLAR For patients currently taking VRAYLAR 1.5 or 3 mg once daily, adjust VRAYLAR dosage to 1.5 mg every other day For patients currently taking VRAYLAR 4.5 or 6 mg once daily, the VRAYLAR dosage should be reduced to 1.5 mg once daily Initiating VRAYLAR while already on a moderate CYP3A4 inhibitor Bipolar I depression and as adjunctive therapy to antidepressants for MDD: VRAYLAR starting dose is 1.5 mg every other day Bipolar I acute manic or mixed episodes and schizophrenia: start VRAYLAR at 1.5 mg every other day; increase to 1.5 mg daily, if needed † When a strong or moderate CYP3A4 inhibitor is withdrawn, VRAYLAR dosage may need to be increased † CYP3A4 inducers Concomitant use of VRAYLAR with a CYP3A4 inducer has not been evaluated and is not recommended † Depending upon clinical response and tolerability. Pharmacokinetics ~3-6 hours to peak plasma concentration 1 after 1 dose of VRAYLAR 1.5 mg/day ~7-day half-life 1 VRAYLAR plasma concentration decreased by ~50% in approximately 1 week ‡ ‡ After multiple dose administration of VRAYLAR, mean cariprazine and DCAR concentrations reached steady state at around Week 1 to Week 2 and mean DDCAR concentrations approached steady state around Week 4 to Week 8 in a 12-week study. The half-lives based on time to reach steady state were 2 to 4 days for cariprazine, ~1 to 2 days for DCAR, and approximately 1 to 3 weeks for DDCAR. The time to reach steady state for DDCAR was variable across patients, with some not achieving steady state at the end of the 12-week treatment. After discontinuation of VRAYLAR, mean plasma concentrations of cariprazine and DCAR decreased by ~50% in ~1 day, and mean plasma concentration of DDCAR decreased by ~50% 1 week after the last dose. The decline in plasma concentrations of active drug and metabolites may not be immediately reflected in patients’ clinical symptoms. 1 Review access BP-I=bipolar I disorder; DCAR=desmethylcariprazine; DDCAR=didesmethylcariprazine; MDD=major depressive disorder. 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. 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 and moderate 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 adult 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%). VRAYLAR is available in 0.5 mg, 0.75 mg, 1.5 mg, 3 mg, 4.5 mg, and 6 mg capsules. INDICATIONS AND USAGE VRAYLAR (cariprazine) is indicated for adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults, for the treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults, for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older, and for the treatment of schizophrenia in adult and pediatric patients 13 years of age and older. US-VRAA-250443 Please also see full Prescribing Information , including Boxed Warnings. References: VRAYLAR [package insert]. North Chicago, IL: AbbVie Inc.; 2024. Data on file, AbbVie Inc. Important Safety Information Full Prescribing Information About AbbVie Site Map Accessibility Statement Contact Us Terms of Use Privacy Notice Cookies Settings Your Privacy Choices US-VRAA-240301 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. © 2025 AbbVie. All rights reserved. VRAYLAR ® and its design are trademarks of Allergan Pharmaceuticals International Limited, an AbbVie company. VRAYPAY SM is a service mark of Allergan Pharmaceuticals International Limited, an AbbVie company. You are about to enter a site that is for U.S. Healthcare Professionals only. By selecting "Yes" below, you certify that you are a Healthcare Professional and that you wish to proceed to the Healthcare Professionals Only section on the AbbVie Medical Information site. Products or treatments described on this site are available in the U.S. but may not be available in all other countries. I am a licensed Healthcare Professional and wish to proceed to the Healthcare Professionals Only AbbVie Medical Information Site. Yes No US-VRAA-240301 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. 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. 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 and moderate 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 adult 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%). VRAYLAR is available in 0.5 mg, 0.75 mg, 1.5 mg, 3 mg, 4.5 mg, and 6 mg capsules. INDICATIONS AND USAGE VRAYLAR (cariprazine) is indicated for adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults, for the treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults, for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older, and for the treatment of schizophrenia in adult and pediatric patients 13 years of age and older. US-VRAA-250443 Please also see full Prescribing Information , including Boxed Warnings.