REXULTI® (brexpiprazole) | SZ | Safety Profile Skip to main content This site is intended for u.s. healthcare professionals U.S. full prescribing information Schizophrenia (SZ) select the Indication Schizophrenia (SZ) AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE MAJOR DEPRESSIVE DISORDER (ADJUNCTIVE) SCHIZOPHRENIA (SZ) Partial Response Is Partial Response Good Enough? Patient Profiles Efficacy Data Primary Endpoint Study Design Summary Non-Pivotal Study Data Additional Analysis Post hoc Analysis Safety Profile Adverse Reactions Discontinuations Metabolic Profile Clinical Pharmacology Clinical Pharmacology Pharmacodynamic Profile Pharmacodynamics Video Dosing & Titration Dosing & Titration Schedule Dosing Adjustments Sample Starter Packs Savings & Coverage Savings Offer Coverage Formulary Lookup Coverage Support Resources For Your Patients For Your Practice Efficacy Data Short-term Efficacy PANSS Total Score: Disease Severity Maintenance Efficacy Data Safety Profile Adverse Reactions Additional Safety Metabolic Profile Patient Profile Clinical Pharmacology Dosing & Titration Dosing & Titration Schedule Dosing Adjustments Sample Starter Packs Savings & Coverage Savings Offer Coverage Formulary Lookup Coverage Support Resources For Your Patients For Your Practice Symptoms Symptoms Disease Burden Efficacy Data Primary Endpoint Full Study Design Secondary Endpoint CMAI Scale Safety Profile Adverse Reactions Discontinuations Extension Dosing & Titration Dosing & Titration Schedule Dose Adjustments Patient/Caregiver Profiles Clinical Pharmacology Savings & Coverage Coverage Formulary Lookup Coverage Support Savings Offer Resources For Your Patients and Caregivers For Your Practice Request a Rep Find Speaker Programs For Patients AND & Caregivers select the Indication Schizophrenia (SZ) AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE MAJOR DEPRESSIVE DISORDER (ADJUNCTIVE) SCHIZOPHRENIA (SZ) Partial Response Is Partial Response Good Enough? Patient Profiles Efficacy Data Primary Endpoint Study Design Summary Non-Pivotal Study Data Additional Analysis Post hoc Analysis Safety Profile Adverse Reactions Discontinuations Metabolic Profile Clinical Pharmacology Clinical Pharmacology Pharmacodynamic Profile Pharmacodynamics Video Dosing & Titration Dosing & Titration Schedule Dosing Adjustments Sample Starter Packs Savings & Coverage Savings Offer Coverage Formulary Lookup Coverage Support Resources For Your Patients For Your Practice Efficacy Data Short-term Efficacy PANSS Total Score: Disease Severity Maintenance Efficacy Data Safety Profile Adverse Reactions Additional Safety Metabolic Profile Patient Profile Clinical Pharmacology Dosing & Titration Dosing & Titration Schedule Dosing Adjustments Sample Starter Packs Savings & Coverage Savings Offer Coverage Formulary Lookup Coverage Support Resources For Your Patients For Your Practice Symptoms Symptoms Disease Burden Efficacy Data Primary Endpoint Full Study Design Secondary Endpoint CMAI Scale Safety Profile Adverse Reactions Discontinuations Extension Dosing & Titration Dosing & Titration Schedule Dose Adjustments Patient/Caregiver Profiles Clinical Pharmacology Savings & Coverage Coverage Formulary Lookup Coverage Support Savings Offer Resources For Your Patients and Caregivers For Your Practice Skip to Important Safety Information Adverse Reactions Adverse Reactions Additional Safety Metabolic Profile Demonstrated safety profile for REXULTI® (brexpiprazole) in adults Study 3 and Study 4: REXULTI—adverse reactions that occurred in ≥2% of patients and greater incidence vs placebo from two 6-week pivotal trials Study 3 and Study 4 adverse reactions REXULTI vs placebo Demonstrated safety profile Akathisia 6 % 5 % Weight increased 4 % 2 % 2 % Diarrhea Dyspepsia Tremor 1 % 1 % 3 % 2 % 3 % 2 % 3 % Blood creatinine phosphokinase increased 1 % 2 % Sedation Placebo (n=368) REXULTI (all doses) (n=852) Study 3 and Study 4: REXULTI— adverse reactions that occurred in ≥2% of patients and greater incidence vs placebo from two 6-week pivotal trials Most common adverse reaction occurring in ≥4% of patients and at least twice the rate of placebo was weight increased In both trials, akathisia occurred most often during the first 3 weeks of treatment, and no incidences resulted in treatment discontinuation 1,2 The safety population included patients receiving 1 mg/day Additional safety information across 2 pivotal trials REXULTI—safety considerations evaluated over 6 weeks 3 REXULTI safety considerations evaluated over 6 weeks Additional safety information P r olactin 3 Elect r oca r diog r am 5 % 4 % Did not p r olong the Q T c in t er v al t o a n y clinically r el ev ant e x t ent No clinically meanin g ful chan g es Placebo (n=368) REXULTI (all doses) (n=852) QTc, corrected QT. View dosing information and titration schedule REXULTI: Metabolic data across all doses in short- and long-term trials in adults WEIGHT CHANGE WEIGHT CHANGE METABOLIC CHANGE WEIGHT CHANGE Weight change results across all doses 4,5 Weight change results across all doses Weight change Placebo REXULTI 4 % of patients 10 % of patients 2 % 5 of patients 2 % 5 of patients 20 % of patients 10 % of patients REXULTI Weight change ≥ 7% increase in body weight ≥ 7% decrease in body weight Mean weight increased b 0.2 kg 4 1.2 kg 4 52 weeks 2.0 kg 26 weeks 1.3 kg 6-week, placebo-controlled, fixed-dose pivotal trials 52-week, open-label, flexible-dose trials a a After the conclusion of the 6-week trial, patients who elected to remain in the trial, patients from the Phase 2 trial, and de novo patients were treated with flexible doses of REXULTI (1 mg to 6 mg) in a 52-week, open-label trial, and no placebo control was included. Safety data were collected at regular intervals throughout the 52 weeks. The overall N was 813; n values for individual parameters varied. 6 b SD for mean weight increased at 6 weeks were 3.4 kg for REXULTI and 2.7 kg for placebo, at 26 weeks was 5.5 kg for REXULTI, and at 52 weeks was 7.3 kg for REXULTI. 6,7 The standard conversion for kilograms (kg) to pounds (lb) is 1 kg for 2.20462 lb. SD, standard deviation. Discontinuation due to weight increased across all doses 6,8 Weight change results across all doses Weight change a After the conclusion of the 6-week trial, patients who elected to remain in the trial, patients from the Phase 2 trial, and de novo patients were treated with flexible doses of REXULTI (1 mg to 6 mg) in a 52-week, open-label trial, and no placebo control was included. Safety data were collected at regular intervals throughout the 52 weeks. The overall N was 813; n values for individual parameters varied. 6 METABOLIC CHANGE Percentage of patients whose values shifted from baseline to post-baseline 6,9 Metabolic profile in short- and long-term trials Metabolic change Cholesterol Triglycerides Fasting serum glucose % of patients who shifted from: Similar rates between REXULTI and placebo Similar rates between REXULTI and placebo 6 % 6 2 % 6 17 % 6 13 % 6 0.4 % 6 0.6 % 6 10 % REXULTI Placebo REXULTI 52-week, open-label, flexible-dose trials a 6-week, placebo-controlled, fixed-dose pivotal trials < 150 mg/dL ≥ 200 to < 500 mg/dL Normal High < 150 mg/dL ≥ 500 mg/dL Normal Very High < 150 mg/dL ≥ 150 to < 200 mg/dL ≥ 500 mg/dL Normal Borderline Very High Fasting total cholesterol < 200 mg/dL ≥ 240 mg/dL Normal High Fasting LDL cholesterol < 100 mg/dL ≥ 160 mg/dL Normal High Fasting HDL cholesterol ≥ 40 mg/dL < 40 mg/dL Normal Low 9 % 9 6 % 6 0.2 % 9 0 % 9 0 % 6 0.2 % 9 Normal Borderline High < 100 mg/dL ≥ 100 to < 126 mg/dL ≥ 126 mg/dL Percentage of patients whose values shifted from baseline to post-baseline 6,9 a After the conclusion of the 6-week trial, patients who elected to remain in the trial, patients from the Phase 2 trial, and de novo patients were treated with flexible doses of REXULTI (1 mg to 6 mg) in a 52-week, open-label trial, and no placebo control was included. Safety data were collected at regular intervals throughout the 52 weeks. The overall N was 813; n values for individual parameters varied. 6 HDL, high-density lipoprotein; LDL, low-density lipoprotein. Important Warning and Precaution for Metabolic Changes Atypical antipsychotic drugs have been associated with metabolic changes that include Hyperglycemia/Diabetes Mellitus, Dyslipidemia, and Weight Gain. Clinical monitoring is recommended. Have more questions? Request a representative Continue exploring REXULTI Review results from pivotal clinical trials for REXULTI. VIEW SZ DATA Consider a patient with unresolved symptoms. MEET DAVE Full Prescribing Information Please see FULL PRESCRIBING INFORMATION , including BOXED WARNING . References: 1. Correll CU, Skuban A, Ouyang J, et al. Efficacy and safety of brexpiprazole for the treatment of acute schizophrenia: a 6-week randomized, double-blind, placebo-controlled trial. Am J Psychiatry . 2015;172(9):870-880. 2. Kane JM, Skuban A, Ouyang J, et al. A multicenter, randomized, double-blind, controlled phase 3 trial of fixed-dose brexpiprazole for the treatment of adults with acute schizophrenia. Schizophr Res . 2015;164(1-3):127-135. 3. Data on file (REX-032). 4. Data on file (REX-029). 5. Data on file (REX-173). 6. Weiss C, Skuban A, Hobart M, et al. The metabolic tolerability profile of brexpiprazole (OPC-34712) in acute schizophrenia. Poster presented at: American Society of Clinical Psychopharmacology Annual Meeting; June 22-25, 2015; Miami, FL. 7. Data on file (REX-175). 8. Data on file (REX-033). 9. Data on file (REX-028). Footer logos Otsuka Lundbeck © 2025 Otsuka America Pharmaceutical, Inc. All rights reserved. Footer menu Privacy Policy Terms of Use June 2025 11US25EBP0178 ISI Block Title INDICATIONS and IMPORTANT SAFETY INFORMATION for REXULTI® (brexpiprazole) INDICATIONS REXULTI is indicated for: Use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults Treatment of schizophrenia in adults and pediatric patients ages 13 years and older Treatment of agitation associated with dementia due to Alzheimer’s disease Limitations of Use : REXULTI is not indicated as an as needed (“prn”) treatment for agitation associated with dementia due to Alzheimer’s disease. IMPORTANT SAFETY INFORMATION WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at increased risk of death. REXULTI is not approved for the treatment of patients with dementia-related psychosis without agitation associated with dementia due to Alzheimer’s disease. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric patients and young adult patients. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors. The safety and effectiveness of REXULTI have not been established in pediatric patients with MDD. Contraindication: In patients with known hypersensitivity to brexpiprazole or any of its components. Reactions have included: rash, facial swelling, urticaria, and anaphylaxis. Cerebrovascular Adverse Events, Including Stroke: In clinical trials, elderly patients with dementia randomized to risperidone, aripiprazole, and olanzapine had a higher incidence of stroke and transient ischemic attack, including fatal stroke. REXULTI is not approved for the treatment of patients with dementia-related psychosis without agitation associated with dementia due to Alzheimer’s disease. Neuroleptic Malignant Syndrome (NMS): NMS is a potentially fatal symptom complex reported in association with administration of antipsychotic drugs, including REXULTI. Clinical signs 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. Manage NMS with immediate discontinuation of REXULTI, intensive symptomatic treatment, and monitoring. Tardive Dyskinesia (TD): Risk of TD, and the potential to become irreversible, appear to increase with duration of treatment and total cumulative dose of antipsychotic drugs. TD can develop after relatively brief treatment periods, at low doses, or after discontinuation of treatment. For chronic treatment, use the lowest dose and shortest duration of REXULTI needed to produce a clinical response. If signs and symptoms of TD appear, drug discontinuation should be considered. Metabolic Changes: Atypical antipsychotic drugs, including REXULTI, have caused metabolic changes including: Hyperglycemia/Diabetes Mellitus: Hyperglycemia and diabetes mellitus, in some cases extreme and associated with diabetic ketoacidosis, hyperosmolar coma, or death, have been reported in patients treated with atypical antipsychotics. Assess fasting plasma glucose before or soon after initiation of antipsychotic medication and monitor periodically during long-term treatment. Dyslipidemia: Atypical antipsychotics cause adverse alterations in lipids. Before or soon after initiation of antipsychotic medication, obtain a fasting lipid profile at baseline and monitor periodically during treatment. Weight Gain: Weight gain has been observed in patients treated with REXULTI. Monitor weight at baseline and frequently thereafter. Pathological Gambling and Other Compulsive Behaviors: Intense urges, particularly for gambling, and the inability to control these urges have been reported while taking REXULTI. Other compulsive urges have been reported less frequently. Prescribers should ask patients or their caregivers about the development of new or intense compulsive urges. Consider dose reduction or stopping REXULTI if such urges develop. Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia and neutropenia have been reported with antipsychotics. Agranulocytosis (including fatal cases) has been reported with other agents in this class. 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 REXULTI at the first sign of a clinically significant decline in WBC and in patients with severe neutropenia. 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. Monitor in patients vulnerable to hypotension and those with cardiovascular and cerebrovascular diseases. Falls: Antipsychotics may cause somnolence, postural hypotension, and motor and sensory instability, which may lead to falls causing fractures or other injuries. For patients with diseases, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating treatment and recurrently during treatment. Seizures: REXULTI may cause seizures and should be used with caution in patients with a history of seizures or with conditions that lower the seizure threshold. Body Temperature Dysregulation: Use REXULTI with caution in patients who may experience conditions that increase body temperature (eg, strenuous exercise, extreme heat, dehydration, or concomitant use with anticholinergics). Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotics, including REXULTI, and should be used with caution in patients at risk for aspiration. Potential for Cognitive and Motor Impairment: REXULTI may cause somnolence and has the potential to impair judgment, thinking, or motor skills. Patients should be cautioned about operating hazardous machinery, including operating motor vehicles, until they are reasonably certain REXULTI does not affect them adversely. Concomitant Medication: Dosage adjustments are recommended in patients who are known cytochrome P450 (CYP) 2D6 poor metabolizers and in patients taking concomitant CYP3A4 inhibitors or CYP2D6 inhibitors or strong CYP3A4 inducers. Most commonly observed adverse reactions: In clinical trials, the most common adverse reactions were: Major Depressive Disorder (MDD) in adults (adjunctive treatment to antidepressant therapy; ≥5% incidence and at least twice the rate of placebo for REXULTI vs placebo): weight increased, somnolence, and akathisia. Schizophrenia in adults (≥5% incidence): weight increased, akathisia, headache, somnolence, and insomnia. Schizophrenia in pediatric patients (≥5% incidence): weight increased, somnolence, headache, akathisia, and nasopharyngitis. Agitation associated with dementia due to Alzheimer’s disease in adults (≥4% incidence and at least twice the rate of placebo for REXULTI vs placebo): nasopharyngitis and dizziness. Dystonia: Symptoms of dystonia may occur in susceptible individuals during the first days of treatment and at low doses. Pregnancy: Adequate and well-controlled studies to assess the risks of REXULTI during pregnancy have not been conducted. REXULTI should be used during pregnancy only if the benefit justifies the risk to the fetus. Lactation: It is not known if REXULTI is excreted in human breast milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 or FDA at 1-800-FDA-1088 ( www.fda.gov/medwatch ). To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 or FDA at 1-800-FDA-1088 ( www.fda.gov/medwatch ). Please see FULL PRESCRIBING INFORMATION , including BOXED WARNING . IMPORTANT SAFETY INFORMATION and INDICATIONS Use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults Treatment of schizophrenia in adults and pediatric patients ages 13 years and older Treatment of agitation associated with Alzheimer’s dementia (AAD) ISI Block Title WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at increased risk of death. REXULTI is not approved for the treatment of patients with dementia-related psychosis without agitation associated with dementia due to Alzheimer’s disease. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric patients and young adult patients. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors. The safety and effectiveness of REXULTI have not been established in pediatric patients with MDD. Contraindication: In patients with known hypersensitivity to brexpiprazole or any of its components. Reactions have included: rash, facial swelling, urticaria, and anaphylaxis. Cerebrovascular Adverse Events, Including Stroke: In clinical trials, elderly patients with dementia randomized to risperidone, aripiprazole, and olanzapine had a higher incidence of stroke and transient ischemic attack, including fatal stroke. REXULTI is not approved for the treatment of patients with dementia-related psychosis without agitation associated with dementia due to Alzheimer’s disease. Neuroleptic Malignant Syndrome (NMS): NMS is a potentially fatal symptom complex reported in association with administration of antipsychotic drugs, including REXULTI. Clinical signs 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. Manage NMS with immediate discontinuation of REXULTI, intensive symptomatic treatment, and monitoring. Tardive Dyskinesia (TD): Risk of TD, and the potential to become irreversible, appear to increase with duration of treatment and total cumulative dose of antipsychotic drugs. TD can develop after relatively brief treatment periods, at low doses, or after discontinuation of treatment. For chronic treatment, use the lowest dose and shortest duration of REXULTI needed to produce a clinical response. If signs and symptoms of TD appear, drug discontinuation should be considered. Metabolic Changes: Atypical antipsychotic drugs, including REXULTI, have caused metabolic changes including: Hyperglycemia/Diabetes Mellitus: Hyperglycemia and diabetes mellitus, in some cases extreme and associated with diabetic ketoacidosis, hyperosmolar coma, or death, have been reported in patients treated with atypical antipsychotics. Assess fasting plasma glucose before or soon after initiation of antipsychotic medication and monitor periodically during long-term treatment. Dyslipidemia: Atypical antipsychotics cause adverse alterations in lipids. Before or soon after initiation of antipsychotic medication, obtain a fasting lipid profile at baseline and monitor periodically during treatment. Weight Gain: Weight gain has been observed in patients treated with REXULTI. Monitor weight at baseline and frequently thereafter. Pathological Gambling and Other Compulsive Behaviors: Intense urges, particularly for gambling, and the inability to control these urges have been reported while taking REXULTI. Other compulsive urges have been reported less frequently. Prescribers should ask patients or their caregivers about the development of new or intense compulsive urges. Consider dose reduction or stopping REXULTI if such urges develop. Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia and neutropenia have been reported with antipsychotics. Agranulocytosis (including fatal cases) has been reported with other agents in this class. 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 REXULTI at the first sign of a clinically significant decline in WBC and in patients with severe neutropenia. 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. Monitor in patients vulnerable to hypotension and those with cardiovascular and cerebrovascular diseases. Falls: Antipsychotics may cause somnolence, postural hypotension, and motor and sensory instability, which may lead to falls causing fractures or other injuries. For patients with diseases, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating treatment and recurrently during treatment. Seizures: REXULTI may cause seizures and should be used with caution in patients with a history of seizures or with conditions that lower the seizure threshold. Body Temperature Dysregulation: Use REXULTI with caution in patients who may experience conditions that increase body temperature (eg, strenuous exercise, extreme heat, dehydration, or concomitant use with anticholinergics). Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotics, including REXULTI, and should be used with caution in patients at risk for aspiration. Potential for Cognitive and Motor Impairment: REXULTI may cause somnolence and has the potential to impair judgment, thinking, or motor skills. Patients should be cautioned about operating hazardous machinery, including operating motor vehicles, until they are reasonably certain REXULTI does not affect them adversely. Concomitant Medication: Dosage adjustments are recommended in patients who are known cytochrome P450 (CYP) 2D6 poor metabolizers and in patients taking concomitant CYP3A4 inhibitors or CYP2D6 inhibitors or strong CYP3A4 inducers. Most commonly observed adverse reactions: In clinical trials, the most common adverse reactions were: Major Depressive Disorder (MDD) in adults (adjunctive treatment to antidepressant therapy; ≥5% incidence and at least twice the rate of placebo for REXULTI vs placebo): weight increased, somnolence, and akathisia. Schizophrenia in adults (≥5% incidence): weight increased, akathisia, headache, somnolence, and insomnia. Schizophrenia in pediatric patients (≥5% incidence): weight increased, somnolence, headache, akathisia, and nasopharyngitis. Agitation associated with dementia due to Alzheimer’s disease in adults (≥4% incidence and at least twice the rate of placebo for REXULTI vs placebo): nasopharyngitis and dizziness. Dystonia: Symptoms of dystonia may occur in susceptible individuals during the first days of treatment and at low doses. Pregnancy: Adequate and well-controlled studies to assess the risks of REXULTI during pregnancy have not been conducted. REXULTI should be used during pregnancy only if the benefit justifies the risk to the fetus. Lactation: It is not known if REXULTI is excreted in human breast milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 or FDA at 1-800-FDA-1088 ( www.fda.gov/medwatch ). INDICATIONS REXULTI is indicated for: Use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults Treatment of schizophrenia in adults and pediatric patients ages 13 years and older Treatment of agitation associated with dementia due to Alzheimer’s disease Limitations of Use : REXULTI is not indicated as an as needed (“prn”) treatment for agitation associated with dementia due to Alzheimer’s disease. Please see FULL PRESCRIBING INFORMATION , including BOXED WARNING . ↑