{
 "query": "brexpiprazole",
 "ingredient": "brexpiprazole",
 "slug": "brexpiprazole",
 "rxcui": "1658314",
 "brands": [
  "Rexulti"
 ],
 "names": [
  "brexpiprazole"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 3
  },
  "boxed_warning": "WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS 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. Brexpiprazole tablets are not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions ( 5.1 )] . Suicidal Thoughts and Behaviors Antidepressants increased the risk of suicidal thoughts and behaviors in patients aged 24 years and younger in short-term studies. Monitor closely for clinical worsening and for emergence of suicidal thoughts and behaviors. The safety and effectiveness of brexpiprazole tablets have not been established in pediatric patients with MDD [see Warnings and Precautions ( 5.2 ), Use in Specific Populations ( 8.4 )] . WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at increased risk of death. Brexpiprazole t...",
  "indications_and_usage": "Brexpiprazole tablets are indicated for: Adjunctive treatment of major depressive disorder (MDD) in adults. Treatment of schizophrenia in adults. Brexpiprazole tablets is an atypical antipsychotic indicated for: Use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults ( 1 , 14.1 ) Treatment of schizophrenia in adults",
  "contraindications": "Brexpiprazole tablets are contraindicated in patients with a known hypersensitivity to brexpiprazole or any of its components. Reactions have included rash, facial swelling, urticaria, and anaphylaxis. Known hypersensitivity to brexpiprazole tablets or any of its components ( 4 )",
  "warnings_and_cautions": "Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack). ( 5.3 ) Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring. ( 5.4 ) Tardive Dyskinesia: Discontinue if clinically appropriate. ( 5.5 ) Metabolic Changes: Monitor for hyperglycemia/diabetes mellitus, dyslipidemia and weight gain. ( 5.6 ) Pathological Gambling and Other Compulsive Behaviors: Consider dose reduction or discontinuation. ( 5.7 ) Leukopenia, Neutropenia, and Agranulocytosis: Perform complete blood counts (CBC) in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. Consider discontinuing brexpiprazole tablets if a clinically significant decline in WBC occurs in absence of other causative factors. ( 5.8 ) Orthostatic Hypotension and Syncope: Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease, and risk of dehydration or syncope. ( 5.9 ) Seizures: Use cautiously in patients with a history of seizures or with conditions that lower the seizure thres...",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are discussed in more detail in other sections of the labeling: Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see Boxed Warning, Warnings and Precautions ( 5.1 )] Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see Boxed Warning, Warnings and Precautions ( 5.2 )] Cerebrovascular Adverse Reactions Including Stroke in Elderly Patients with Dementia-Related Psychosis [see Warnings and Precautions ( 5.3 )] Neuroleptic Malignant Syndrome (NMS) [see Warnings and Precautions ( 5.4 )] Tardive Dyskinesia [see Warnings and Precautions ( 5.5 )] Metabolic Changes [see Warnings and Precautions ( 5.6 )] Pathological Gambling and Other Compulsive Behaviors [see Warnings and Precautions ( 5.7 )] Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions ( 5.8 )] Orthostatic Hypotension and Syncope [see Warnings and Precautions ( 5.9 )] Falls [see Warnings and Precautions ( 5.10 )] Seizures [see Warnings and Precautions ( 5.11 )] Body Temperature Dysregulation [see Warnings and Precautions ( 5.12 )] Dysphagia [see Warnings and Precautions ( 5.13 )] Potential for Cognitive and Motor Impairment [see Warnings a...",
  "drug_abuse_and_dependence": "9.1 Controlled Substance Brexpiprazole is not a controlled substance. 9.2 Abuse Animals given access to brexpiprazole tablets did not self-administer the drug, suggesting that brexpiprazole tablets does not have rewarding properties. 9.3 Dependence Humans and animals that received chronic brexpiprazole tablets administration did not demonstrate any withdrawal signs upon drug discontinuation. This suggests that brexpiprazole tablets does not produce physical dependence.",
  "controlled_substance": "9.1 Controlled Substance Brexpiprazole is not a controlled substance.",
  "recent_major_changes": "Boxed Warning 12/2021 Warnings and Precautions ( 5.6 ) 12/2021",
  "information_for_patients": "Advise the patient or caregiver to read the FDA-approved patient labeling (Medication Guide). Suicidal Thoughts and Behaviors Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dosage is adjusted up or down, and instruct them to report such symptoms to the healthcare provider [ see Boxed Warning, Warnings and Precautions ( 5.2 )]. Dosage and Administration Advise patients that brexpiprazole tablets can be taken with or without food. Advise patients regarding importance of following dosage escalation instructions [see Dosage and Administration ( 2.1 ), ( 2.2 )]. Neuroleptic Malignant Syndrome (NMS) Counsel patients about a potentially fatal adverse reaction - neuroleptic malignant syndrome (NMS) - that has been reported in association with administration of antipsychotic drugs. Advise patients to contact a healthcare provider or report to the emergency room if they experience signs or symptoms of NMS [see Warnings and Precautions ( 5.4 )]. Tardive Dyskinesia Counsel patients on the signs and symptoms of tardive dyskinesia and to contact their healthcare provider if these abnormal movements occur [see Warnings and P...",
  "spl_medguide": "MEDICATION GUIDE Brexpiprazole (breks PIP ray zole) Tablets What is the most important information I should know about brexpiprazole tablets? Brexpiprazole tablets may cause serious side effects, including: Increased risk of death in elderly people with dementia-related psychosis. Medicines like brexpiprazole tablets can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). Brexpiprazole tablets are not approved for the treatment of people with dementia-related psychosis. Increased risk of suicidal thoughts and actions. Antidepressant medicines may increase suicidal thoughts and actions in some children, adolescents, and young adults especially within the first few months of treatment or when the dose is changed. Depression and other mental illnesses are the most important causes of suicidal thoughts and actions. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when brexpiprazole tablets or the antidepressant medicine is started o...",
  "clinical_studies": "14.1 Adjunctive Treatment of Major Depressive Disorder The efficacy of brexpiprazole tablets in the adjunctive treatment of major depressive disorder (MDD) was evaluated in two 6-week double-blind, placebo-controlled, fixed-dose trials of adult patients meeting DSM-IV-TR criteria for MDD, with or without symptoms of anxiety, who had an inadequate response to prior antidepressant therapy (1 to 3 courses) in the current episode and who had also demonstrated an inadequate response throughout the 8 weeks of prospective antidepressant treatment (with escitalopram, fluoxetine, paroxetine controlled-release, sertraline, duloxetine delayed release, or venlafaxine extended release). Inadequate response during the prospective antidepressant treatment phase was defined as having persistent symptoms without substantial improvement throughout the course of treatment. Patients in Study 228 (hereafter \u201cStudy 1\u201d) were randomized to brexpiprazole tablets 2 mg once a day or placebo. Patients in Study 227 (hereafter \u201cStudy 2\u201d) were randomized to brexpiprazole tablets 1 mg or 3 mg once a day or placebo. For patients randomized to brexpiprazole tablets, all patients initiated treatment at 0.5 mg once d...",
  "brand_name": "Brexpiprazole",
  "manufacturer": "Ajanta Pharma USA Inc.",
  "application_number": "ANDA213718",
  "pharm_class_epc": [
   "Atypical Antipsychotic [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20221213",
  "set_id": "993b584c-7fe6-4551-899f-39146c8508ac",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 16513,
  "serious": 6866,
  "death": 1084,
  "hospitalization": 2119,
  "primary_suspect": 16411,
  "top_reactions": [
   [
    "Weight Increased",
    1704
   ],
   [
    "Product Use In Unapproved Indication",
    1348
   ],
   [
    "Off Label Use",
    1152
   ],
   [
    "Drug Ineffective",
    961
   ],
   [
    "Akathisia",
    869
   ],
   [
    "Tremor",
    654
   ],
   [
    "Anxiety",
    612
   ],
   [
    "Tardive Dyskinesia",
    599
   ],
   [
    "Depression",
    584
   ],
   [
    "Suicidal Ideation",
    565
   ],
   [
    "Death",
    553
   ],
   [
    "Product Use Issue",
    511
   ],
   [
    "Fatigue",
    506
   ],
   [
    "Insomnia",
    506
   ],
   [
    "Feeling Abnormal",
    481
   ]
  ],
  "by_year": {
   "2019": 1701,
   "2020": 1423,
   "2021": 1433,
   "2022": 1328,
   "2023": 1444,
   "2024": 1778,
   "2025": 1372,
   "2026": 716
  },
  "by_year_primary": {
   "2019": 1698,
   "2020": 1420,
   "2021": 1429,
   "2022": 1307,
   "2023": 1415,
   "2024": 1767,
   "2025": 1347,
   "2026": 710
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 17,
  "nda": 1,
  "anda": 12,
  "first_approval": "20150710",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 6,
  "labeling_recent": 3,
  "sponsors": [
   "ACCORD HLTHCARE INC",
   "AJANTA PHARMA LTD",
   "ALEMBIC",
   "ALKEM LABS LTD",
   "AMNEAL",
   "APOTEX",
   "AUROBINDO PHARMA LTD",
   "CHARTWELL RX"
  ],
  "unapproved": false,
  "first_approval_fmt": "07/10/2015"
 },
 "trials": {
  "total": 89,
  "completed": 65,
  "terminated": 11,
  "with_results": 58,
  "industry": 80,
  "phase3": 50,
  "results_share": 0.8923076923076924,
  "terminated_share": 0.12359550561797752
 },
 "pubmed": {
  "rct": 50,
  "meta": 19,
  "recent_rct": 30,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 11118567.61,
  "records": 201077,
  "by_name": [
   [
    "Rexulti",
    11118567.61
   ]
  ],
  "names_checked": [
   "brexpiprazole",
   "Rexulti"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 598492,
  "beneficiaries": 94695,
  "spend": 861392149.79,
  "by_brand": [
   {
    "brand": "Rexulti",
    "claims": 598492,
    "per_claim": 1439.2709506,
    "is_generic": false
   }
  ],
  "per_claim": 1439.2709506392732
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "ApplicationRejected",
  "name": "brexpiprazole",
  "matched": "brexpiprazole",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 3824,
  "fills": 598492,
  "per_million": 6389.392005239836,
  "ratio": 2.3075146078376245,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 58,
   "letter": "D",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "6,389 FDA reports naming it as the suspect drug per million Medicare fills, 2.3x the median drug on this site (-7)",
    "Death share in reports is near or below the FAERS average (0.7x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 54,
   "letter": "D",
   "why": [
    "50 randomized trials and 19 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 91,
   "letter": "A",
   "why": [
    "No recalls on record since 2016",
    "3 label changes approved since 2021 (-4)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 55,
   "letter": "D",
   "why": [
    "Pharma paid doctors $11,118,568 tied to this drug last year (-45)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "Generic versions approved (12 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 63,
 "grade": "C",
 "questions": [
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "The most-reported problems in FDA's adverse event data are weight increased, product use in unapproved indication. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "The manufacturer pays physicians heavily to promote this drug. Have you received anything from them?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}