{
 "query": "dupilumab",
 "ingredient": "dupilumab",
 "slug": "dupilumab",
 "rxcui": "1876376",
 "brands": [
  "Dupixent"
 ],
 "names": [
  "dupilumab"
 ],
 "classes": [
  {
   "id": "D11AH",
   "name": "Agents for dermatitis, excluding corticosteroids"
  }
 ],
 "alternatives": [
  "abrocitinib",
  "alitretinoin",
  "crisaborole",
  "cromolyn",
  "delgocitinib",
  "lebrikizumab",
  "nemolizumab",
  "pimecrolimus",
  "ruxolitinib",
  "tacrolimus",
  "tralokinumab"
 ],
 "label": {
  "route_mode": "SUBCUTANEOUS",
  "route_counts": {
   "SUBCUTANEOUS": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "is an interleukin-4 receptor alpha antagonist indicated: Atopic Dermatitis for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids. ( 1.1 ) Asthma as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma. ( 1.2 ) Limitations of Use: Not for the relief of acute bronchospasm or status asthmaticus. ( 1.2 ) Chronic Rhinosinusitis with Nasal Polyps as an add-on maintenance treatment in adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). ( 1.3 ) Eosinophilic Esophagitis for the treatment of adult and pediatric patients aged 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis (EoE). ( 1.4 ) Prurigo Nodularis for the treatment of adult patients with prurigo nodularis (PN). ( 1.5 ) Chronic Obstructive Pulmonary Diseas...",
  "contraindications": "is contraindicated in patients who have known hypersensitivity to dupilumab or any excipients of DUPIXENT [see Warnings and Precautions (5.1) ] . Known hypersensitivity to dupilumab or any excipients in DUPIXENT. ( 4 )",
  "warnings_and_cautions": "Hypersensitivity: Hypersensitivity reactions including anaphylaxis, acute generalized exanthematous pustulosis (AGEP), serum sickness, angioedema, urticaria, rash, erythema nodosum, and erythema multiforme have occurred. Discontinue DUPIXENT in the event of a hypersensitivity reaction. ( 5.1 ) Conjunctivitis, Keratitis, and Blepharitis: Advise patients to promptly report new onset or worsening eye symptoms to their healthcare provider. If symptoms persist or worsen, consider discontinuation of DUPIXENT. Consider ophthalmological examination, as appropriate. ( 5.2 ) Eosinophilic Conditions: Be alert to vasculitic rash, worsening pulmonary symptoms, cardiac complications, kidney injury and/or neuropathy, especially upon reduction of oral corticosteroids. ( 5.3 ) Reduction of Corticosteroid Dosage: Do not discontinue systemic, topical, or inhaled corticosteroids abruptly upon initiation of DUPIXENT. Decrease steroids gradually, if appropriate. ( 5.5 ) Psoriasis: Advise patients to report new-onset psoriasis symptoms to their healthcare provider. If symptoms persist or worsen, consider dermatologic evaluation and/or discontinuation of DUPIXENT. ( 5.7 ) Arthralgia and Psoriatic Arthriti...",
  "warnings": "",
  "adverse_reactions": "The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Warnings and Precautions (5.1) ] Conjunctivitis and Keratitis [see Warnings and Precautions (5.2) ] Psoriasis [see Warnings and Precautions (5.7) ] Arthralgia and Psoriatic Arthritis [see Warnings and Precautions (5.8) ] Parasitic (Helminth) Infections [see Warnings and Precautions (5.9) ] Most common adverse reactions are: Atopic Dermatitis (incidence \u22651%): injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye, and eosinophilia. ( 6.1 ) Asthma (incidence \u22651%): injection site reactions, oropharyngeal pain, and eosinophilia. ( 6.1 ) Chronic Rhinosinusitis with Nasal Polyps (incidence \u22651%): injection site reactions, eosinophilia, insomnia, toothache, gastritis, arthralgia, and conjunctivitis. ( 6.1 ) Eosinophilic Esophagitis (incidence \u22652%): injection site reactions, upper respiratory tract infections, arthralgia, and herpes viral infections. ( 6.1 ) Prurigo Nodularis (incidence \u22652%): nasopharyngitis, conjunctivitis, herpes infection, dizziness, myalgia, and diarrhea. ( 6.1 ) Chronic ...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Indications and Usage, Chronic Spontaneous Urticaria ( 1.7 ) 04/2026 Indications and Usage, Bullous Pemphigoid ( 1.8 ) 06/2025 Indications and Usage, Allergic Fungal Rhinosinusitis ( 1.9 ) 02/2026 Dosage and Administration, Chronic Spontaneous Urticaria ( 2.9 ) 04/2026 Dosage and Administration, Bullous Pemphigoid ( 2.10 ) 06/2025 Dosage and Administration, Allergic Fungal Rhinosinusitis ( 2.11 ) 02/2026 Dosage and Administration, Missed Doses ( 2.12 ) 06/2025 Warnings and Precautions, Hypersensitivity ( 5.1 ) 06/2025 Warnings and Precautions, Conjunctivitis, Keratitis, and Blepharitis ( 5.2 ) 04/2026",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Pregnancy Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to DUPIXENT during pregnancy [see Use in Specific Populations (8.1) ] . Administration Instructions Provide proper training to patients and/or caregivers on proper subcutaneous injection technique, including aseptic technique, and the preparation and administration of DUPIXENT prior to use. Advise patients to follow sharps disposal recommendations [see Dosage and Administration (2.1) and Instructions for Use] . Hypersensitivity Advise patients to discontinue DUPIXENT and to seek immediate medical attention if they experience any symptoms of systemic hypersensitivity reactions [see Warnings and Precautions (5.1) ] . Advise patients to report signs and symptoms of AGEP to their healthcare provider [see Warnings and Precautions (5.1) ] . Conjunctivitis, Keratitis, and Blepharitis Advise patients to promptly consult their healthcare provider if new onset or worsening eye symptoms develop [see Warnings and Precautions (5.2) ] . Eosinophilic Conditions Advise patients to not...",
  "spl_medguide": "",
  "clinical_studies": "14.1 Atopic Dermatitis Adults with Atopic Dermatitis Three randomized, double-blind, placebo-controlled trials (SOLO 1 (NCT02277743), SOLO 2 (NCT02277769), and CHRONOS (NCT02260986)) enrolled a total of 2119 adult subjects with moderate-to-severe AD not adequately controlled by topical medication(s). Disease severity was defined by an Investigator's Global Assessment (IGA) score \u22653 in the overall assessment of AD lesions on a severity scale of 0 to 4, an Eczema Area and Severity Index (EASI) score \u226516 on a scale of 0 to 72, and a minimum body surface area involvement of \u226510%. At baseline, the mean age of subjects was 38 years; 59% of subjects were male, 67% were White, 24% were Asian, and 6% were Black; 52% of subjects had a baseline IGA score of 3 (moderate AD), and 48% of subjects had a baseline IGA of 4 (severe AD). The baseline mean EASI score was 33 and the baseline weekly averaged Peak Pruritus Numeric Rating Scale (NRS) was 7 on a scale of 0-10. In all three trials, subjects in the DUPIXENT group received subcutaneous injections of DUPIXENT 600 mg at Week 0, followed by 300 mg every 2 weeks (Q2W). In the monotherapy trials (SOLO 1 and SOLO 2), subjects received DUPIXENT or p...",
  "brand_name": "Dupixent",
  "manufacturer": "Sanofi-Aventis U.S. LLC",
  "application_number": "BLA761055",
  "pharm_class_epc": [
   "Interleukin-4 Receptor alpha Antagonist [EPC]"
  ],
  "route": [
   "SUBCUTANEOUS"
  ],
  "effective_time": "20260422",
  "set_id": "595f437d-2729-40bb-9c62-c8ece1f82780",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 479026,
  "serious": 52851,
  "death": 2194,
  "hospitalization": 22583,
  "primary_suspect": 478974,
  "top_reactions": [
   [
    "Pruritus",
    58695
   ],
   [
    "Dermatitis Atopic",
    45026
   ],
   [
    "Product Use In Unapproved Indication",
    41226
   ],
   [
    "Rash",
    38630
   ],
   [
    "Injection Site Pain",
    36707
   ],
   [
    "Drug Ineffective",
    30014
   ],
   [
    "Eczema",
    26628
   ],
   [
    "Dry Skin",
    25981
   ],
   [
    "Product Dose Omission Issue",
    25295
   ],
   [
    "Condition Aggravated",
    20687
   ],
   [
    "Arthralgia",
    19297
   ],
   [
    "Inappropriate Schedule Of Product Administration",
    18597
   ],
   [
    "Asthma",
    16153
   ],
   [
    "Accidental Exposure To Product",
    15818
   ],
   [
    "Skin Exfoliation",
    14758
   ]
  ],
  "by_year": {
   "2019": 14912,
   "2020": 20265,
   "2021": 40310,
   "2022": 58510,
   "2023": 66769,
   "2024": 88403,
   "2025": 114880,
   "2026": 66184
  },
  "by_year_primary": {
   "2019": 14912,
   "2020": 20265,
   "2021": 40306,
   "2022": 58502,
   "2023": 66759,
   "2024": 88389,
   "2025": 114870,
   "2026": 66178
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 1,
  "nda": 0,
  "anda": 0,
  "first_approval": "20170328",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 0,
  "labeling_recent": 0,
  "sponsors": [
   "REGENERON PHARMACEUTICALS"
  ],
  "unapproved": false,
  "first_approval_fmt": "03/28/2017"
 },
 "trials": {
  "total": 308,
  "completed": 143,
  "terminated": 21,
  "with_results": 86,
  "industry": 209,
  "phase3": 58,
  "results_share": 0.6013986013986014,
  "terminated_share": 0.06818181818181818
 },
 "pubmed": {
  "rct": 165,
  "meta": 100,
  "recent_rct": 126,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 38721104.88,
  "records": 283304,
  "by_name": [
   [
    "Dupixent",
    38721104.88
   ]
  ],
  "names_checked": [
   "dupilumab",
   "Dupixent"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 621396,
  "beneficiaries": 88374,
  "spend": 2491772008.05,
  "by_brand": [
   {
    "brand": "Dupixent Pen",
    "claims": 450526,
    "per_claim": 4005.6587987,
    "is_generic": false
   },
   {
    "brand": "Dupixent Syringe",
    "claims": 170870,
    "per_claim": 4021.2943884,
    "is_generic": false
   }
  ],
  "per_claim": 4009.9582360523727
 },
 "mdl": [
  {
   "number": "3180",
   "title": "Dupixent (Dupilumab) Products Liability Litigation",
   "judge": "Quraishi, Zahid N.",
   "court": "NJ",
   "docket": "3:26-md-3180",
   "actions": "",
   "matched": "dupixent"
  }
 ],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 269437,
  "fills": 621396,
  "per_million": 433599.50820410816,
  "ratio": 156.5934909474431,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 85,
   "letter": "B",
   "why": [
    "433,600 FDA reports naming it as the suspect drug per million Medicare fills, 156.6x the median drug on this site (-15)",
    "Death share in reports is near or below the FAERS average (0.1x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 73,
   "letter": "C",
   "why": [
    "165 randomized trials and 100 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": 15,
   "letter": "F",
   "why": [
    "Pharma paid doctors $38,721,105 tied to this drug last year (-45)",
    "Named in 1 active federal multidistrict litigation(s) (-40)"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "No generic version approved: brand-only pricing (-30)",
    "11 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 72,
 "grade": "C",
 "questions": [
  "The most-reported problems in FDA's adverse event data are pruritus, dermatitis atopic, product use in unapproved indication, rash. How would we recognize and handle those?",
  "Why this one over abrocitinib, alitretinoin, crisaborole? What would make you pick one of those instead?",
  "There is no generic. Is there an older generic in the same class that works as well for my situation?",
  "The manufacturer pays physicians heavily to promote this drug. Have you received anything from them?",
  "This drug is in active federal litigation. What is the claim, and does it affect my risk?",
  "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.)"
 ]
}