{
 "query": "donanemab",
 "ingredient": "donanemab",
 "slug": "donanemab",
 "rxcui": "2687966",
 "brands": [],
 "names": [
  "donanemab"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "INTRAVENOUS",
  "route_counts": {
   "INTRAVENOUS": 1
  },
  "boxed_warning": "WARNING: AMYLOID RELATED IMAGING ABNORMALITIES Monoclonal antibodies directed against aggregated forms of beta amyloid, including KISUNLA, 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 hemorrhages >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 in a patient being treated with KISUNLA [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's disease patients) treated with this class of medications, including KISUNLA, have a higher incidence of ARIA, including symptomatic, serious, and severe ra...",
  "indications_and_usage": "is indicated for the treatment of Alzheimer's disease. Treatment with KISUNLA should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in the clinical trials. KISUNLA is an amyloid beta-directed antibody indicated for the treatment of Alzheimer's disease. Treatment with KISUNLA should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in the clinical trials. ( 1 )",
  "contraindications": "is contraindicated in patients with known serious hypersensitivity to donanemab-azbt or to any of the excipients. Reactions have included anaphylaxis [see Warnings and Precautions ( 5.2 )] . KISUNLA is contraindicated in patients with known serious hypersensitivity to donanemab-azbt or to any of the excipients. ( 4 , 5.2 )",
  "warnings_and_cautions": "Amyloid Related Imaging Abnormalities (ARIA): Enhanced clinical vigilance for ARIA is recommended during the first 24 weeks of treatment with KISUNLA. Risk of ARIA, including symptomatic ARIA, was increased in apolipoprotein E \u03b54 (ApoE \u03b54) homozygotes compared to heterozygotes and noncarriers. The risk of ARIA-E and ARIA-H is increased in KISUNLA-treated 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. ( 2.3 , 5.1 ) Infusion-Related Reactions: The infusion rate may be reduced, or the infusion may be discontinued, and appropriate therapy initiated as clinically indicated. Consider pre-treatment with antihistamines, acetaminophen, or corticosteroids prior to subsequent dosing. ( 5.3 ) 5.1 Amyloid Related Imaging Abnormalities Monoclonal antibodies directed against aggregated forms of beta amyloid, including KISUNLA, 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 ...",
  "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 least 10% and higher incidence compared to placebo): ARIA-E, ARIA-H microhemorrhage, ARIA-H superficial siderosis, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) 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. Dosing Regimen and Safety A lower incidence of ARIA occurred with the dosing regimen administered in Study 2 (350 mg/700 mg/1,050 mg/1,400 mg; Dosing Regimen 2) as compared to the regimen administered in Study 1 (700 mg/700 mg/700 mg/1,400 mg; Dosing Regimen 1); therefore, Do...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Boxed Warning 07/2025 Dosage and Administration ( 2.2 , 2.3 , 2.4 , 2.5 ) 07/2025 Warnings and Precautions ( 5.1 , 5.3 ) 07/2025",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Amyloid Related Imaging Abnormalities Inform patients that KISUNLA may cause Amyloid Related Imaging Abnormalities or \u201cARIA\u201d. ARIA most commonly presents 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. 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 KISUNLA, and that use of antithrombotic or thrombolytic medications while taking KISUNLA may increase the risk of bleeding in the brain. Notify patients that their healthcare provide...",
  "spl_medguide": "This Medication Guide has been approved by the U.S. Food and Drug Administration Issued: 7/2024 MEDICATION GUIDE KISUNLA\u2122 (kih-SUHN-lah) (donanemab-azbt) injection, for intravenous use What is the most important information I should know about KISUNLA? KISUNLA can cause serious side effects, including: Amyloid Related Imaging Abnormalities or ARIA. ARIA is a common 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: headache confusion dizziness vision changes nausea seizures difficulty walking Some people have a genetic risk factor (homozygous apolipoprotein E \u03b54 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 medicin...",
  "clinical_studies": "The effectiveness of KISUNLA for the treatment of Alzheimer's disease was established by Study 1, which assessed Dosing Regimen 1 (700 mg every 4 weeks for the first 3 doses, and then 1,400 mg every 4 weeks). Study 2 was conducted to assess different titration regimens, including Dosing Regimen 2 (doses every 4 weeks with 350 mg the first infusion, 700 mg the second infusion, 1,050 mg the third infusion, and then 1,400 mg every 4 weeks) that demonstrated comparable pharmacodynamic effects on amyloid plaque reduction with a reduced incidence of ARIA-related events compared to Dosing Regimen 1 [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.1 ), Clinical Pharmacology ( 12.2 )] . Study 1 The efficacy of KISUNLA was evaluated in a double-blind, placebo-controlled, parallel-group study (Study 1, NCT04437511) in patients with Alzheimer's disease (patients with confirmed presence of amyloid pathology and mild cognitive impairment or mild dementia stage of disease, consistent with Stage 3 and Stage 4 Alzheimer's disease). Patients were enrolled with a Mini-Mental State Examination (MMSE) score of \u226520 and \u226428 and had a progressive change in memory function for at least ...",
  "brand_name": "Kisunla",
  "manufacturer": "Eli Lilly and Company",
  "application_number": "BLA761248",
  "pharm_class_epc": [],
  "route": [
   "INTRAVENOUS"
  ],
  "effective_time": "20251230",
  "set_id": "190352d4-ef62-4679-b4fa-e846e2766afa",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 255,
  "serious": 199,
  "death": 10,
  "hospitalization": 72,
  "primary_suspect": 255,
  "top_reactions": [
   [
    "Cerebral Haemorrhage",
    41
   ],
   [
    "Amyloid Related Imaging Abnormality-Oedema/Effusion",
    31
   ],
   [
    "Amyloid Related Imaging Abnormality-Microhaemorrhages And Haemosiderin Deposits",
    27
   ],
   [
    "Headache",
    27
   ],
   [
    "Infusion Related Reaction",
    23
   ],
   [
    "Dyspnoea",
    19
   ],
   [
    "Flushing",
    19
   ],
   [
    "Vomiting",
    17
   ],
   [
    "Dizziness",
    16
   ],
   [
    "Chest Discomfort",
    15
   ],
   [
    "Fall",
    15
   ],
   [
    "Nausea",
    15
   ],
   [
    "Erythema",
    12
   ],
   [
    "Chills",
    11
   ],
   [
    "Fatigue",
    11
   ]
  ],
  "by_year": {
   "2024": 4,
   "2025": 53,
   "2026": 198
  },
  "by_year_primary": {
   "2024": 4,
   "2025": 53,
   "2026": 198
  }
 },
 "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": 20,
  "completed": 5,
  "terminated": 0,
  "with_results": 7,
  "industry": 16,
  "phase3": 8,
  "results_share": 1.4,
  "terminated_share": 0.0
 },
 "pubmed": {
  "rct": 17,
  "meta": 6,
  "recent_rct": 17,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "donanemab"
  ],
  "source": "bulk-index"
 },
 "partd": null,
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 70,
   "letter": "C",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 39,
   "letter": "F",
   "why": [
    "17 randomized trials and 6 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": 68,
 "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 cerebral haemorrhage, amyloid related imaging abnormality-oedema/effusion, amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits, headache. 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.)"
 ]
}