{
 "query": "daratumumab",
 "ingredient": "daratumumab",
 "slug": "daratumumab",
 "rxcui": "1721947",
 "brands": [
  "Darzalex"
 ],
 "names": [
  "daratumumab"
 ],
 "classes": [
  {
   "id": "L01FC",
   "name": "CD38 (Clusters of Differentiation 38) inhibitors"
  }
 ],
 "alternatives": [
  "isatuximab"
 ],
 "label": {},
 "faers": {
  "total": 39864,
  "serious": 33743,
  "death": 5072,
  "hospitalization": 13749,
  "primary_suspect": 39833,
  "top_reactions": [
   [
    "Plasma Cell Myeloma",
    3899
   ],
   [
    "Off Label Use",
    3559
   ],
   [
    "Infusion Related Reaction",
    2676
   ],
   [
    "Pneumonia",
    2037
   ],
   [
    "Neutropenia",
    2021
   ],
   [
    "Fatigue",
    1765
   ],
   [
    "Diarrhoea",
    1747
   ],
   [
    "Drug Ineffective",
    1586
   ],
   [
    "Death",
    1485
   ],
   [
    "Neuropathy Peripheral",
    1478
   ],
   [
    "Thrombocytopenia",
    1420
   ],
   [
    "Dyspnoea",
    1326
   ],
   [
    "Pyrexia",
    1317
   ],
   [
    "Anaemia",
    1217
   ],
   [
    "Nausea",
    1131
   ]
  ],
  "by_year": {
   "2019": 3495,
   "2020": 3612,
   "2021": 4323,
   "2022": 5039,
   "2023": 5621,
   "2024": 5281,
   "2025": 4100,
   "2026": 2149
  },
  "by_year_primary": {
   "2019": 3495,
   "2020": 3612,
   "2021": 4323,
   "2022": 5031,
   "2023": 5618,
   "2024": 5267,
   "2025": 4094,
   "2026": 2149
  }
 },
 "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": "20151116",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 0,
  "labeling_recent": 0,
  "sponsors": [
   "JANSSEN BIOTECH"
  ],
  "unapproved": false,
  "first_approval_fmt": "11/16/2015"
 },
 "trials": {
  "total": 451,
  "completed": 120,
  "terminated": 66,
  "with_results": 98,
  "industry": 292,
  "phase3": 87,
  "results_share": 0.8166666666666667,
  "terminated_share": 0.14634146341463414
 },
 "pubmed": {
  "rct": 90,
  "meta": 25,
  "recent_rct": 61,
  "cochrane": [
   {
    "pmid": "38695605",
    "title": "Daratumumab and antineoplastic therapy versus antineoplastic therapy only for adults with newly diagnosed multiple myeloma ineligible for transplant",
    "year": "2024"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 2764033.2,
  "records": 14092,
  "by_name": [
   [
    "Darzalex",
    2764033.2
   ]
  ],
  "names_checked": [
   "daratumumab",
   "Darzalex"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1702,
  "beneficiaries": 201,
  "spend": 18004961.67,
  "by_brand": [
   {
    "brand": "Darzalex",
    "claims": 1702,
    "per_claim": 10578.708384,
    "is_generic": false
   }
  ],
  "per_claim": 10578.70838425382
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "ApplicationRejected",
  "name": "daratumumab",
  "matched": "daratumumab",
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 95,
   "letter": "A",
   "why": [
    "Death share in reports is near or below the FAERS average (1.4x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 65,
   "letter": "C",
   "why": [
    "90 randomized trials and 25 systematic reviews/meta-analyses indexed in PubMed",
    "1 independent Cochrane review(s) exist"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 100,
   "letter": "A",
   "why": [
    "No recalls on record since 2016"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 70,
   "letter": "C",
   "why": [
    "Pharma paid doctors $2,764,033 tied to this drug last year (-30)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 60,
   "letter": "D",
   "why": [
    "No generic version approved: brand-only pricing (-30)",
    "1 same-class alternative(s) (-10)"
   ],
   "weight": 0.1
  }
 },
 "total": 81,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are plasma cell myeloma, infusion related reaction, pneumonia. 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 isatuximab? 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?",
  "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.)"
 ]
}