{
 "query": "tralokinumab",
 "ingredient": "tralokinumab",
 "slug": "tralokinumab",
 "rxcui": "2589225",
 "brands": [],
 "names": [
  "tralokinumab"
 ],
 "classes": [
  {
   "id": "D11AH",
   "name": "Agents for dermatitis, excluding corticosteroids"
  }
 ],
 "alternatives": [
  "abrocitinib",
  "alitretinoin",
  "crisaborole",
  "cromolyn",
  "delgocitinib",
  "dupilumab",
  "lebrikizumab",
  "nemolizumab",
  "pimecrolimus",
  "ruxolitinib",
  "tacrolimus"
 ],
 "label": {
  "route_mode": "SUBCUTANEOUS",
  "route_counts": {
   "SUBCUTANEOUS": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. ADBRY can be used with or without topical corticosteroids. ADBRY is an interleukin-13 antagonist indicated for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. ADBRY can be used with or without topical corticosteroids. ( 1 )",
  "contraindications": "is contraindicated in patients who have known hypersensitivity to tralokinumab-ldrm or any excipients in ADBRY [see Warnings and Precautions (5.1) ] . Known hypersensitivity to tralokinumab-ldrm or any excipients in ADBRY. ( 4 )",
  "warnings_and_cautions": "Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, and angioedema have occurred after administration of ADBRY. Discontinue ADBRY in the event of a hypersensitivity reaction. ( 5.1 ) Conjunctivitis and Keratitis: Patients should report new onset or worsening eye symptoms to their healthcare provider. ( 5.2 ) Parasitic (Helminth) Infections: Treat patients with pre-existing helminth infections before initiating treatment with ADBRY. If patients become infected while receiving ADBRY and do not respond to anti-helminth treatment, discontinue treatment with ADBRY until the infection resolves. ( 5.3 ) Risk of Infection with Live Vaccines: Avoid use of live vaccines. ( 5.4 ) 5.1 Hypersensitivity Hypersensitivity reactions including anaphylaxis and angioedema have been reported with use of ADBRY. If a serious hypersensitivity reaction occurs, discontinue ADBRY immediately and initiate appropriate therapy. 5.2 Conjunctivitis and Keratitis Conjunctivitis and keratitis occurred more frequently in atopic dermatitis subjects who received ADBRY. Conjunctivitis was the most frequently reported eye disorder. Most subjects with conjunctivitis or keratitis recovered or were recover...",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are discussed in greater detail elsewhere in the labeling: Hypersensitivity [see Warnings and Precautions (5.1) ] Conjunctivitis and Keratitis [see Warnings and Precautions (5.2) ] Most common adverse reactions (incidence \u2265 1%) are upper respiratory tract infections, conjunctivitis, injection site reactions, and eosinophilia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact LEO Pharma Inc. at 1-877-494-4536 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. Adverse Reactions from Clinical Trials in Adults The safety of ADBRY was evaluated in a pool of 5 randomized, double-blind, placebo-controlled trials in subjects with moderate-to-severe atopic dermatitis including three phase 3 Eczema Tralokinumab trials (ECZTRA 1, ECZTRA 2, and ECZTRA 3), a dose-finding trial, and a vaccine response trial. The safety population had a mean age of 37 years; 43% of subje...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Advise the patients to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Administration Instructions Instruct patients or caregivers: to perform the first self-injection under the supervision and guidance of a qualified healthcare provider for proper training in subcutaneous injection technique. to inject the full dose of ADBRY. to follow sharps disposal recommendations [see Instructions for Use ]. Hypersensitivity Advise patients to discontinue ADBRY and to seek immediate medical attention if they experience any symptoms of systemic hypersensitivity reactions [see Warnings and Precautions (5.1) ] . Conjunctivitis and Keratitis Advise patients to consult their healthcare provider if new onset or worsening eye symptoms develop [see Adverse Reactions (6.1) ]. Risk of Infection with Live Vaccines Instruct patients to inform the healthcare provider that they are taking ADBRY prior to a potential vaccination [see Warnings and Precautions (5.4) ] . Pregnancy Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADBRY during pregnancy. Encourage participation and advise patients about how they may enroll i...",
  "spl_medguide": "",
  "clinical_studies": "Adults The efficacy of ADBRY was assessed in three randomized, double-blind, placebo-controlled trials [ECZTRA 1 (NCT03131648), ECZTRA 2 (NCT03160885), and ECZTRA 3 (NCT03363854)]. Efficacy was assessed in a total of 1934 subjects 18 years of age and older with moderate-to-severe atopic dermatitis (AD) not adequately controlled by topical medication(s). Disease severity was defined by an Investigator's Global Assessment (IGA) score \u2265 3 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 (BSA) involvement of \u226510%. At baseline, 58% of subjects were male, 69% of subjects were White, 50% of subjects had a baseline IGA score of 3 (moderate AD), and 50% of subjects had a baseline IGA score of 4 (severe AD). The baseline mean EASI score was 32 and the baseline weekly averaged Worst Daily Pruritus Numeric Rating Scale (NRS) was 8 on a scale of 0-10. In all three trials, subjects received subcutaneous injections of ADBRY 600 mg or placebo on Day 0, followed by 300 mg every other week or placebo for 16 weeks. Responders were defined as achieving an IGA 0 or 1 (\"clear\" ...",
  "brand_name": "Adbry",
  "manufacturer": "LEO Pharma Inc.",
  "application_number": "BLA761180",
  "pharm_class_epc": [
   "Interleukin-13 Antagonist [EPC]"
  ],
  "route": [
   "SUBCUTANEOUS"
  ],
  "effective_time": "20251217",
  "set_id": "d8020b69-3001-44e2-9b5d-5f93d9aaf6e1",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 150,
  "serious": 134,
  "death": 3,
  "hospitalization": 46,
  "primary_suspect": 150,
  "top_reactions": [
   [
    "Drug Ineffective",
    13
   ],
   [
    "Pruritus",
    12
   ],
   [
    "Off Label Use",
    10
   ],
   [
    "Condition Aggravated",
    9
   ],
   [
    "Conjunctivitis",
    7
   ],
   [
    "Erythema",
    7
   ],
   [
    "Arthralgia",
    6
   ],
   [
    "Cutaneous T-Cell Lymphoma",
    6
   ],
   [
    "Dermatitis Atopic",
    6
   ],
   [
    "Dizziness",
    6
   ],
   [
    "Eczema",
    6
   ],
   [
    "Eczema Herpeticum",
    6
   ],
   [
    "Weight Increased",
    6
   ],
   [
    "Eye Pruritus",
    5
   ],
   [
    "Fatigue",
    5
   ]
  ],
  "by_year": {
   "2016": 1,
   "2018": 1,
   "2019": 1,
   "2022": 27,
   "2023": 21,
   "2024": 13,
   "2025": 26,
   "2026": 59
  },
  "by_year_primary": {
   "2016": 1,
   "2018": 1,
   "2019": 1,
   "2022": 27,
   "2023": 21,
   "2024": 13,
   "2025": 26,
   "2026": 59
  }
 },
 "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": "20211227",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 0,
  "labeling_recent": 0,
  "sponsors": [
   "LEO PHARMA AS"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/27/2021"
 },
 "trials": {
  "total": 46,
  "completed": 29,
  "terminated": 6,
  "with_results": 27,
  "industry": 37,
  "phase3": 15,
  "results_share": 0.9310344827586207,
  "terminated_share": 0.13043478260869565
 },
 "pubmed": {
  "rct": 27,
  "meta": 4,
  "recent_rct": 15,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "tralokinumab"
  ],
  "source": "bulk-index"
 },
 "partd": null,
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [],
   "weight": 0.35
  },
  "evidence": {
   "score": 36,
   "letter": "F",
   "why": [
    "27 randomized trials and 4 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 90,
   "letter": "A",
   "why": [
    "No recalls on record since 2016",
    "Approved within the last 5 years: long-term safety is not yet known (-10)"
   ],
   "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": 70,
   "letter": "C",
   "why": [
    "No generic version approved: brand-only pricing (-30)",
    "11 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 80,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are pruritus, condition aggravated. 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?",
  "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?",
  "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.)"
 ]
}