{
 "query": "lecanemab",
 "ingredient": "lecanemab",
 "slug": "lecanemab",
 "rxcui": "2626143",
 "brands": [],
 "names": [
  "lecanemab"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "INTRAVENOUS",
  "route_counts": {
   "INTRAVENOUS": 1,
   "SUBCUTANEOUS": 1
  },
  "boxed_warning": "WARNING: AMYLOID RELATED IMAGING ABNORMALITIES Monoclonal antibodies directed against aggregated forms of beta amyloid, including LEQEMBI, can cause amyloid related imaging abnormalities (ARIA), characterized as ARIA with edema (ARIA-E) and ARIA with hemosiderin deposition (ARIA-H). Incidence and timing of ARIA vary among treatments. ARIA usually occurs early in treatment and is usually asymptomatic, although serious and life-threatening events can occur. ARIA can be fatal. Serious intracerebral hemorrhage s > 1 cm, some of which have been fatal, have been observed in patients treated with this class of medications. Because ARIA-E can cause focal neurologic deficits that can mimic an ischemic stroke, treating clinicians should consider whether such symptoms could be due to ARIA-E before giving thrombolytic therapy to a patient being treated with LEQEMBI [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6.1 )]. ApoE \u03b54 Homozygotes Patients who are apolipoprotein E \u03b54 (ApoE \u03b54) homozygotes (approximately 15% of Alzheimer\u2019s disease patients) treated with this class of medications, including LEQEMBI, have a higher incidence of ARIA, including symptomatic, serious, and severe r...",
  "indications_and_usage": "is indicated for the treatment of Alzheimer\u2019s disease. Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. LEQEMBI is an amyloid beta-directed antibody indicated for the treatment of Alzheimer\u2019s disease. Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. ( 1 )",
  "contraindications": "is contraindicated in patients with serious hypersensitivity to lecanemab-irmb or to any of the excipients. Reactions have included angioedema and anaphylaxis [see Warnings and Precautions ( 5.2 )] . LEQEMBI is contraindicated in patients with serious hypersensitivity to lecanemab-irmb or to any of the excipients. ( 4 )",
  "warnings_and_cautions": "Amyloid Related Imaging Abnormalities (ARIA): Enhanced clinical vigilance for ARIA is recommended during the first 14 weeks of treatment with LEQEMBI. Risk of ARIA, including symptomatic ARIA, was increased in apolipoprotein E \u03b54 homozygotes compared to heterozygotes and noncarriers. The risk of ARIA-E and ARIA-H is increased in patients with pretreatment microhemorrhages and/or superficial siderosis. If a patient experiences symptoms suggestive of ARIA, clinical evaluation should be performed, including MRI scanning if indicated. ( 2.4 , 5.1 ) Infusion-Related Reactions: The infusion rate may be reduced, or the infusion may be discontinued, and appropriate therapy administered as clinically indicated. Consider pre-medication at subsequent dosing with antihistamines, non-steroidal anti-inflammatory drugs, or corticosteroids. ( 5.3 ) 5.1 Amyloid Related Imaging Abnormalities Monoclonal antibodies directed against aggregated forms of beta amyloid, including LEQEMBI, can cause amyloid related imaging abnormalities (ARIA), characterized as ARIA with edema (ARIA-E), which can be observed on MRI as brain edema or sulcal effusions, and ARIA with hemosiderin deposition (ARIA-H), which incl...",
  "warnings": "",
  "adverse_reactions": "The following clinically significant adverse reactions are described elsewhere in the labeling: Amyloid Related Imaging Abnormalities [see Warnings and Precautions ( 5.1 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.2 )] Infusion-Related Reactions [see Warnings and Precautions ( 5.3 )] Most common adverse reactions (at approximately 10% and higher incidence compared to placebo): infusion-related reactions, amyloid related imaging abnormality-microhemorrhages, amyloid related imaging abnormality-edema/effusion, and headache. Additionally, injection-related reactions occurred in patients receiving subcutaneously administered LEQEMBI. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eisai Inc. at 1-888-274-2378 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trials with Intravenous Administration The safety of LEQEMBI has been evaluated in 2090 patients who rec...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Dosage and Administration ( 2.5 ) 8/2025 Dosage and Administration ( 2.2 , 2.3 , 2.4 , 2.6 , 2.7 ) 7/2026 Contraindications ( 4 ) 8/2025 Warnings and Precautions ( 5.1 ) 12/2025 Warnings and Precautions ( 5.2 , 5.3 ) 8/2025",
  "information_for_patients": "Advise the patient and/or caregiver to read the FDA-approved patient labeling ( Medication Guide and Instructions for Use ). Amyloid Related Imaging Abnormalities Inform patients that LEQEMBI may cause Amyloid Related Imaging Abnormalities or \u201cARIA\u201d. ARIA most commonly presents as a temporary swelling in areas of the brain that usually resolves over time. Some people may also have small spots of bleeding in or on the surface of the brain. Inform patients that most people with swelling in areas of the brain do not experience symptoms; however, some people may experience symptoms such as headache, confusion, dizziness, vision changes, nausea, aphasia, weakness, or seizure. Instruct patients to notify their healthcare provider immediately if these symptoms occur. Clinical evaluation should be performed, and an MRI may be considered. Inform patients that serious symptoms of ARIA may occur and that ARIA can be fatal. Inform patients that events of intracerebral hemorrhage greater than 1 cm in diameter have been reported infrequently in patients taking LEQEMBI, and that the use of antithrombotic or thrombolytic medications while taking LEQEMBI may increase the risk of bleeding in the bra...",
  "spl_medguide": "MEDICATION GUIDE LEQEMBI \u00ae (leh-kem\u2019-bee) (lecanemab-irmb) injection, for intravenous or subcutaneous use What is the most important information I should know about LEQEMBI? LEQEMBI can cause serious side effects including: Amyloid Related Imaging Abnormalities or \u201cARIA\u201d. ARIA is a side effect that does not usually cause any symptoms but serious symptoms can occur. ARIA can be fatal. It is most commonly seen as temporary swelling in areas of the brain that usually resolves over time. Some people may also have small spots of bleeding in or on the surface of the brain, and infrequently, larger areas of bleeding in the brain can occur. Most people who develop ARIA do not get symptoms; however, some people may have symptoms, such as: \u25cb headache \u25cb vision changes \u25cb seizures \u25cb confusion \u25cb nausea \u25cb difficulty speaking \u25cb dizziness \u25cb difficulty walking \u25cb muscle weakness Some people have a genetic risk factor (homozygous apolipoprotein E gene carriers) that may cause an increased risk for ARIA. Talk to your healthcare provider about testing to see if you have this risk factor. You may be at a higher risk of developing bleeding in the brain if you take medicines to reduce blood clots from form...",
  "clinical_studies": "The efficacy of LEQEMBI was evaluated in two double-blind, placebo-controlled, parallel-group, randomized studies (Study 1, NCT01767311; Study 2 NCT03887455) in patients with Alzheimer\u2019s disease (patients with confirmed presence of amyloid pathology and mild cognitive impairment [64% of patients in Study 1; 62% of patients in Study 2] or mild dementia stage of disease [36% of patients in Study 1; 38% of patients in Study 2], consistent with Stage 3 and Stage 4 Alzheimer\u2019s disease). In both studies, patients were enrolled with a Clinical Dementia Rating (CDR) global score of 0.5 or 1.0 and a Memory Box score of 0.5 or greater. All patients had a Mini-Mental State Examination (MMSE) score of \u226522 and \u226430, and had objective impairment in episodic memory as indicated by at least 1 standard deviation below age-adjusted mean in the Wechsler-Memory Scale-IV Logical Memory II (subscale) (WMS-IV LMII). Patients were enrolled with or without concomitant approved therapies (cholinesterase inhibitors and the N-methyl-D-aspartate antagonist memantine) for Alzheimer\u2019s disease. The dosage of 10 mg/kg administered once every 2 weeks by intravenous infusion was assessed in the 18-month placebo-contr...",
  "brand_name": "LEQEMBI",
  "manufacturer": "Eisai Inc.",
  "application_number": "BLA761269",
  "pharm_class_epc": [
   "Amyloid Beta-directed Antibody [EPC]"
  ],
  "route": [
   "INTRAVENOUS",
   "SUBCUTANEOUS"
  ],
  "effective_time": "20260721",
  "set_id": "9d1ff786-e577-410a-a273-c4d7d0e4e975",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 299,
  "serious": 257,
  "death": 35,
  "hospitalization": 157,
  "primary_suspect": 298,
  "top_reactions": [
   [
    "Amyloid Related Imaging Abnormality-Oedema/Effusion",
    66
   ],
   [
    "Amyloid Related Imaging Abnormality-Microhaemorrhages And Haemosiderin Deposits",
    52
   ],
   [
    "Infusion Related Reaction",
    27
   ],
   [
    "Cerebral Haemorrhage",
    20
   ],
   [
    "Dizziness",
    19
   ],
   [
    "Confusional State",
    15
   ],
   [
    "Pyrexia",
    15
   ],
   [
    "Headache",
    14
   ],
   [
    "Syncope",
    12
   ],
   [
    "Drug Ineffective",
    11
   ],
   [
    "Fall",
    10
   ],
   [
    "Vomiting",
    9
   ],
   [
    "Chills",
    8
   ],
   [
    "Seizure",
    8
   ],
   [
    "Hypotension",
    7
   ]
  ],
  "by_year": {
   "2021": 1,
   "2022": 7,
   "2023": 57,
   "2024": 39,
   "2025": 123,
   "2026": 72
  },
  "by_year_primary": {
   "2021": 1,
   "2022": 7,
   "2023": 57,
   "2024": 39,
   "2025": 122,
   "2026": 72
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 0,
  "nda": 0,
  "anda": 0,
  "first_approval": "",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 0,
  "labeling_recent": 0,
  "sponsors": [],
  "unapproved": false,
  "first_approval_fmt": ""
 },
 "trials": {
  "total": 35,
  "completed": 5,
  "terminated": 0,
  "with_results": 1,
  "industry": 16,
  "phase3": 6,
  "results_share": 0.2,
  "terminated_share": 0.0
 },
 "pubmed": {
  "rct": 11,
  "meta": 14,
  "recent_rct": 11,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "lecanemab"
  ],
  "source": "bulk-index"
 },
 "partd": null,
 "mdl": [],
 "dsc": [
  {
   "date": "20250828",
   "title": "FDA to recommend additional, earlier MRI monitoring for patients with Alzheimer\u2019s disease taking Leqembi (lecanemab)",
   "url": "https://www.fda.gov/drugs/drug-safety-communications/fda-recommend-additional-earlier-mri-monitoring-patients-alzheimers-disease-taking-leqembi-lecanemab",
   "kind": "drug",
   "matched": "lecanemab"
  }
 ],
 "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 2025 (-8)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 41,
   "letter": "F",
   "why": [
    "11 randomized trials and 14 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 95,
   "letter": "A",
   "why": [
    "No recalls on record since 2016",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 40,
   "letter": "F",
   "why": [
    "No generic version approved: brand-only pricing (-30)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 65,
 "grade": "C",
 "questions": [
  "In 2025 the FDA issued a safety communication about this drug (FDA to recommend additional, earlier MRI monitoring for patients with Alzheimer\u2019s disease taking Leqembi (leca). 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 amyloid related imaging abnormality-oedema/effusion, amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits, infusion related reaction, cerebral haemorrhage. How would we recognize and handle those?",
  "There is no generic. Is there an older generic in the same class that works as well for my situation?",
  "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.)"
 ]
}