{
 "query": "asenapine",
 "ingredient": "asenapine",
 "slug": "asenapine",
 "rxcui": "784649",
 "brands": [
  "Saphris",
  "Secuado"
 ],
 "names": [
  "asenapine",
  "asenapine maleate"
 ],
 "classes": [
  {
   "id": "N05AH",
   "name": "Diazepines, oxazepines, thiazepines and oxepines"
  }
 ],
 "alternatives": [
  "clothiapine",
  "clozapine",
  "loxapine",
  "olanzapine",
  "quetiapine"
 ],
 "label": {
  "route_mode": "SUBLINGUAL",
  "route_counts": {
   "SUBLINGUAL": 4,
   "TRANSDERMAL": 1
  },
  "boxed_warning": "WARNING: 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. SAPHRIS \u00ae (asenapine) is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions ( 5.1, 5.2 )] . WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. SAPHRIS is not approved for the treatment of patients with dementia-related psychosis. ( 5.1 , 5.2 )",
  "indications_and_usage": "is indicated for: Schizophrenia in adults [see Clinical Studies ( 14.1 )] Bipolar I disorder [see Clinical Studies ( 14.2 )] \u2022 Acute monotherapy of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age \u2022 Adjunctive treatment to lithium or valproate in adults \u2022 Maintenance monotherapy treatment in adults SAPHRIS is an atypical antipsychotic indicated for ( 1 ): Schizophrenia in adults Bipolar I disorder \u25cb Acute monotherapy treatment of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age \u25cb Adjunctive treatment to lithium or valproate in adults \u25cb Maintenance monotherapy treatment in adults",
  "contraindications": "is contraindicated in patients with: Severe hepatic impairment (Child-Pugh C) [see Specific Populations ( 8.7 ), Clinical Pharmacology ( 12.3 )] . A history of hypersensitivity reactions to asenapine. Reactions have included anaphylaxis, angioedema, hypotension, tachycardia, swollen tongue, dyspnea, wheezing and rash [see Warnings and Precautions ( 5.6 ), Adverse Reactions ( 6 )] . Severe hepatic impairment (Child-Pugh C). ( 8.7 , 12.3 ) Known hypersensitivity to SAPHRIS (asenapine), or to any components in the formulation. ( 4 , 5.6 , 17 )",
  "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). ( 5.2 ) Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring. ( 5.3 ) Tardive Dyskinesia : Discontinue if clinically appropriate. ( 5.4 ) Metabolic Changes : Monitor for hyperglycemia/diabetes mellitus, dyslipidemia, and weight gain. ( 5.5 ) Orthostatic Hypotension: Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease, and risk of dehydration or syncope. ( 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 SAPHRIS if a clinically significant decline in WBC occurs in absence of other causative factors. ( 5.9 ) QT Prolongation: Increases in QT interval; avoid use with drugs that also increase the QT interval and in patients with risk factors for prolonged QT interval. ( 5.10 ) Seizures: Use cautiously in patients with a history of seizures or wi...",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are discussed in more detail in other sections of the labeling: Use in Elderly Patients with Dementia-Related Psychosis [see Boxed Warning and Warnings and Precautions ( 5.1 and 5.2 )] Neuroleptic Malignant Syndrome [see Warnings and Precautions ( 5.3 )] Tardive Dyskinesia [see Warnings and Precautions ( 5.4 )] Metabolic Changes [see Warnings and Precautions ( 5.5 )] Hypersensitivity Reactions [see Contraindications, Warnings and Precautions ( 5.6 )] Orthostatic Hypotension, Syncope, and other Hemodynamic Effects [see Warnings and Precautions ( 5.7 )] Falls [see Warnings and Precautions ( 5.8 )] Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions ( 5.9 )] QT Interval Prolongation [see Warnings and Precautions ( 5.10 )] Hyperprolactinemia [see Warnings and Precautions ( 5.11 )] Seizures [see Warnings and Precautions ( 5.12 )] Potential for Cognitive and Motor Impairment [see Warnings and Precautions ( 5.13 )] Body Temperature Regulation [see Warnings and Precautions ( 5.14 )] Dysphagia [see Warnings and Precautions ( 5.15 )] The most common adverse reactions (\u22655% and at least twice the rate of placebo) reported with acute treatm...",
  "drug_abuse_and_dependence": "9.1 Controlled Substance SAPHRIS is not a controlled substance. 9.2 Abuse SAPHRIS has not been systematically studied in animals or humans for its abuse potential or its ability to induce tolerance or physical dependence. Thus, it is not possible to predict the extent to which a CNS-active drug will be misused, diverted and/or abused once it is marketed. Patients should be evaluated carefully for a history of drug abuse, and such patients should be observed carefully for signs that they are misusing or abusing SAPHRIS (e.g., drug-seeking behavior, increases in dose).",
  "controlled_substance": "9.1 Controlled Substance SAPHRIS is not a controlled substance.",
  "recent_major_changes": "Warnings and Precautions ( 5.11 ) 01/2025",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling ( Instructions for Use ). Dosage and Administration Counsel patients on proper sublingual administration of SAPHRIS and advise them to read the FDA-approved patient labeling ( Instructions for Use ). When initiating treatment with SAPHRIS, provide dosage escalation instructions [see Dosage and Administration ( 2 )]. Hypersensitivity Reactions Counsel patients on the signs and symptoms of a serious allergic reaction (e.g., difficulty breathing, itching, swelling of the face, tongue or throat, feeling lightheaded etc.) and to seek immediate emergency assistance if they develop any of these signs and symptoms [see Contraindications ( 4 ), Warnings and Precautions ( 5.6 ) and Adverse Reactions ( 6 )] . Application Site Reactions Inform patients that application site reactions, primarily in the sublingual area, including oral ulcers, blisters, peeling/sloughing and inflammation have been reported. Instruct patients to monitor for these reactions [see Adverse Reactions ( 6.2 )] . Inform patients that numbness or tingling of the mouth or throat may occur directly after administration of SAPHRIS and usually resolves within 1 hour...",
  "spl_medguide": "",
  "clinical_studies": "Efficacy of SAPHRIS was established in the following trials: Two fixed-dose, short-term trials and one flexible-dose, maintenance trial in adult patients with schizophrenia as monotherapy [ see Clinical Studies ( 14.1 )] One fixed-dose and two flexible-dose, short-term trials of monotherapy in adults with manic or mixed episodes associated with bipolar I disorder [ see Clinical Studies ( 14.2 ) ] One flexible-dose, maintenance trial of monotherapy in adults with bipolar I disorder [ see Clinical Studies ( 14.2 ) ] One fixed-dose, short term trial of monotherapy in children (10 to 17 years) with manic or mixed episodes associated with bipolar I disorder [ see Clinical Studies ( 14.2 ) ] One flexible-dose, short-term trial in adult patients with manic or mixed episode associated with bipolar I disorder as adjunctive treatment to lithium or valproate [ see Clinical Studies ( 14.2 ) ] Figure 4 Figure 5 14.1 Schizophrenia The efficacy of SAPHRIS in the treatment of schizophrenia in adults was evaluated in three fixed-dose, short-term (6 week), randomized, double-blind, placebo-controlled, and active-controlled (haloperidol, risperidone, and olanzapine) trials of adult patients who met D...",
  "brand_name": "SAPHRIS",
  "manufacturer": "Allergan, Inc.",
  "application_number": "NDA022117",
  "pharm_class_epc": [],
  "route": [
   "SUBLINGUAL"
  ],
  "effective_time": "20250131",
  "set_id": "5429f134-839f-4ffc-9944-55f51238def8",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 4024,
  "serious": 2914,
  "death": 368,
  "hospitalization": 1167,
  "primary_suspect": 4008,
  "top_reactions": [
   [
    "Drug Ineffective",
    875
   ],
   [
    "Suicide Attempt",
    677
   ],
   [
    "Sedation",
    561
   ],
   [
    "Dyskinesia",
    473
   ],
   [
    "Dystonia",
    448
   ],
   [
    "Sexual Dysfunction",
    437
   ],
   [
    "Anosognosia",
    436
   ],
   [
    "Off Label Use",
    435
   ],
   [
    "Blood Glucose Increased",
    433
   ],
   [
    "Metabolic Disorder",
    421
   ],
   [
    "Blood Prolactin Abnormal",
    418
   ],
   [
    "Disturbance In Social Behaviour",
    417
   ],
   [
    "Personality Change",
    390
   ],
   [
    "Condition Aggravated",
    340
   ],
   [
    "Schizophrenia",
    340
   ]
  ],
  "by_year": {
   "2019": 480,
   "2020": 390,
   "2021": 397,
   "2022": 387,
   "2023": 292,
   "2024": 160,
   "2025": 196,
   "2026": 68
  },
  "by_year_primary": {
   "2019": 480,
   "2020": 389,
   "2021": 395,
   "2022": 383,
   "2023": 292,
   "2024": 160,
   "2025": 189,
   "2026": 68
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class III",
   "date": "20210419",
   "reason": "Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent",
   "firm": "SigmaPharm Laboratories LLC",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20210419",
   "reason": "Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent",
   "firm": "SigmaPharm Laboratories LLC",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20170518",
   "reason": "Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets",
   "firm": "Forest Laboratories, LLC",
   "status": "Terminated"
  }
 ],
 "recall_total": 3,
 "drugsfda": {
  "applications": 5,
  "nda": 2,
  "anda": 3,
  "first_approval": "20090813",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 13,
  "labeling_recent": 2,
  "sponsors": [
   "ABBVIE",
   "ALEMBIC",
   "BRECKENRIDGE",
   "HISAMITSU",
   "SIGMAPHARM LABS LLC"
  ],
  "unapproved": false,
  "first_approval_fmt": "08/13/2009"
 },
 "trials": {
  "total": 59,
  "completed": 52,
  "terminated": 4,
  "with_results": 30,
  "industry": 53,
  "phase3": 35,
  "results_share": 0.5769230769230769,
  "terminated_share": 0.06779661016949153
 },
 "pubmed": {
  "rct": 43,
  "meta": 12,
  "recent_rct": 5,
  "cochrane": [
   {
    "pmid": "26599405",
    "title": "Asenapine versus placebo for schizophrenia",
    "year": "2015"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 14679.44,
  "records": 877,
  "by_name": [
   [
    "Secuado",
    14679.44
   ]
  ],
  "names_checked": [
   "asenapine",
   "Saphris",
   "Secuado"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 76888,
  "beneficiaries": 12033,
  "spend": 31004483.47,
  "by_brand": [
   {
    "brand": "Asenapine Maleate",
    "claims": 66185,
    "per_claim": 268.17305462,
    "is_generic": true
   },
   {
    "brand": "Saphris",
    "claims": 6204,
    "per_claim": 1155.3487766,
    "is_generic": false
   },
   {
    "brand": "Secuado",
    "claims": 4499,
    "per_claim": 1353.1153679,
    "is_generic": false
   }
  ],
  "per_claim": 403.24216353657266
 },
 "mdl": [],
 "dsc": [
  {
   "date": "20110901",
   "title": "Saphris (asenapine maleate) - Serious allergic reactions reported with the use of Saphris (asenapine maleate)",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm270243.htm",
   "kind": "drug",
   "matched": "saphris"
  }
 ],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 62,
   "letter": "D",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "FDA issued 1 Drug Safety Communication(s) naming this drug since 2010, most recently 2011 (-8)",
    "Death share in reports is near or below the FAERS average (1.0x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 50,
   "letter": "D",
   "why": [
    "43 randomized trials and 12 systematic reviews/meta-analyses indexed in PubMed",
    "1 independent Cochrane review(s) exist",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 86,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 2 Class III (-5)",
    "2 label changes approved since 2021 (-4)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $14,679 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (3 applications)",
    "5 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 72,
 "grade": "C",
 "questions": [
  "In 2011 the FDA issued a safety communication about this drug (Saphris (asenapine maleate) - Serious allergic reactions reported with the use of Saphris (asenapine maleate)). Does that risk apply to me?",
  "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 suicide attempt, sedation, dyskinesia. How would we recognize and handle those?",
  "Why this one over clothiapine, clozapine, loxapine? What would make you pick one of those instead?",
  "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.)"
 ]
}