{
 "query": "trastuzumab",
 "ingredient": "trastuzumab",
 "slug": "trastuzumab",
 "rxcui": "224905",
 "brands": [
  "Herceptin"
 ],
 "names": [
  "trastuzumab",
  "trastuzumab deruxtecan"
 ],
 "classes": [
  {
   "id": "L01FD",
   "name": "HER2 (Human Epidermal Growth Factor Receptor 2) inhibitors"
  }
 ],
 "alternatives": [
  "ado-trastuzumab emtansine",
  "margetuximab",
  "pertuzumab",
  "trastuzumab deruxtecan",
  "zanidatamab"
 ],
 "label": {
  "route_mode": "INTRAVENOUS",
  "route_counts": {
   "INTRAVENOUS": 7
  },
  "boxed_warning": "WARNING: INTERSTITIAL LUNG DISEASE and EMBRYO-FETAL TOXICITY Interstitial Lung Disease (ILD) and pneumonitis, including severe, life-threatening, and fatal cases, have been reported with ENHERTU. Monitor for and promptly investigate signs and symptoms including cough, dyspnea, fever, and other new or worsening respiratory symptoms. Permanently discontinue ENHERTU in all patients with Grade 2 or higher ILD/pneumonitis. Advise patients of the risk and the need to immediately report symptoms [see Dosage and Administration (2.3) , Warnings and Precautions (5.1) ] . Embryo-Fetal Toxicity: Exposure to ENHERTU during pregnancy can cause embryo-fetal harm. Advise patients of these risks and the need for effective contraception [see Warnings and Precautions (5.4) , Use in Specific Populations (8.1 , 8.3) ] . WARNING: INTERSTITIAL LUNG DISEASE and EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. Interstitial lung disease (ILD) and pneumonitis, including severe, life threatening, and fatal cases, have been reported with ENHERTU. Monitor for and promptly investigate signs and symptoms including cough, dyspnea, fever, and other new or worsening respiratory symp...",
  "indications_and_usage": "is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for: HER2-Positive Early Breast Cancer as neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer, as determined by an FDA-authorized test followed by a taxane, trastuzumab, and pertuzumab (THP). ( 1.1 ) as adjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following neoadjuvant trastuzumab (with or without pertuzumab) and taxane-based treatment. ( 1.1 ) HER2-Positive Metastatic Breast Cancer in combination with pertuzumab as first-line treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer, as determined by an FDA-authorized test. ( 1.2 ) as monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or, in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy. ( 1.2 ) HER2-Low and HER2-Ultralow Metastatic Breast Cancer as ...",
  "contraindications": "None . None. ( 4 )",
  "warnings_and_cautions": "Neutropenia: Monitor complete blood counts prior to initiation of ENHERTU and prior to each dose, and as clinically indicated. Manage through treatment interruption or dose reduction. ( 2.3 , 5.2 ) Left Ventricular Dysfunction (LVD): Assess left ventricular ejection fraction (LVEF) prior to initiation of ENHERTU and at regular intervals during treatment as clinically indicated. Manage through treatment interruption or discontinuation. Permanently discontinue ENHERTU in patients with symptomatic congestive heart failure (CHF). ( 2.3 , 5.3 ) 5.1 Interstitial Lung Disease/Pneumonitis Severe, life-threatening, or fatal interstitial lung disease (ILD), including pneumonitis, can occur in patients treated with ENHERTU [see Adverse Reactions (6.1) ] . A higher incidence of Grade 1 and 2 ILD/pneumonitis has been observed in patients with moderate renal impairment. Advise patients to immediately report cough, dyspnea, fever, and/or any new or worsening respiratory symptoms. Monitor patients for signs and symptoms of ILD. Promptly investigate evidence of ILD. Evaluate patients with suspected ILD by radiographic imaging. Consider consultation with a pulmonologist. For asymptomatic (Grade 1) I...",
  "warnings": "",
  "adverse_reactions": "The following clinically significant adverse reactions are described elsewhere in the labeling: Interstitial Lung Disease/Pneumonitis [see Warnings and Precautions (5.1) ] Neutropenia [see Warnings and Precautions (5.2) ] Left Ventricular Dysfunction [see Warnings and Precautions (5.3) ] The most common adverse reactions (\u226520%), including laboratory abnormalities, in patients with: HER2-Positive, HER2-Low, and HER2-Ultralow Breast Cancer, HER2-Mutant NSCLC, and HER2-Positive (including IHC 3+) Solid Tumors are decreased white blood cell count, nausea, decreased hemoglobin, decreased neutrophil count, decreased lymphocyte count, fatigue, decreased platelet count, increased aspartate aminotransferase, increased alanine aminotransferase, increased blood alkaline phosphatase, vomiting, alopecia, constipation, decreased blood potassium, decreased appetite, diarrhea, and musculoskeletal pain. ( 6.1 ) HER2-Positive Early Breast Cancer are decreased hemoglobin, increased alanine aminotransferase, increased aspartate aminotransferase, decreased white blood cell count, nausea, peripheral neuropathy, diarrhea, decreased neutrophil count, alopecia, fatigue, decreased lymphocyte count, rash, mu...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Indications and Usage ( 1.1 ) 05/2026 Indications and Usage ( 1.2 ) 12/2025 Dosage and Administration ( 2.1 , 2.2 , 2.3 ) 05/2026 Dosage and Administration ( 2.1 , 2.2 , 2.3 ) 12/2025 Warnings and Precautions ( 5.1 , 5.2 , 5.3 ) 05/2026 Warnings and Precautions ( 5.1 , 5.2 , 5.3 ) 12/2025",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Medication Guide). Interstitial Lung Disease Inform patients of the risks of severe or fatal ILD. Advise patients to contact their healthcare provider immediately for any of the following: cough, shortness of breath, fever, or other new or worsening respiratory symptoms [see Warnings and Precautions (5.1) ] . Neutropenia Advise patients of the possibility of developing neutropenia and to immediately contact their healthcare provider should they develop a fever, particularly in association with any signs of infection [see Warnings and Precautions (5.2) ] . Left Ventricular Dysfunction Advise patients to contact their healthcare provider immediately for any of the following: new onset or worsening shortness of breath, cough, fatigue, swelling of ankles/legs, palpitations, sudden weight gain, dizziness, loss of consciousness [see Warnings and Precautions (5.3) ] . Embryo-Fetal Toxicity Inform female patients of the potential risk to a fetus. Advise female patients to contact their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.4) , Use in Specific Populations (8.1) ] . Advise females ...",
  "spl_medguide": "This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 05/2026 Medication Guide ENHERTU \u00ae (en-HER-too) (fam-trastuzumab deruxtecan-nxki) for injection What is the most important information I should know about ENHERTU? ENHERTU can cause serious side effects, including: Lung problems that may be severe, life-threatening or that may lead to death. If you develop lung problems your healthcare provider may treat you with corticosteroid medicines. Tell your healthcare provider right away if you get any of the following signs and symptoms: cough trouble breathing or shortness of breath fever other new or worsening breathing symptoms (such as chest tightness, wheezing) Low white blood cell count (neutropenia). Low white blood cell counts are common with ENHERTU and can sometimes be severe. Your healthcare provider will check your white blood cell counts before starting ENHERTU and before starting each dose. Tell your healthcare provider right away if you develop any signs or symptoms of an infection or have fever or chills during treatment with ENHERTU. Heart problems that may affect your heart's ability to pump blood. Your healthcare provider will chec...",
  "clinical_studies": "14.1 HER2-Positive Early Breast Cancer DESTINY-Breast11 The efficacy of ENHERTU followed by THP was evaluated in DESTINY-Breast11 (NCT05113251), a randomized, three-arm, open-label, multicenter, global study that enrolled 927 adult patients with HER2-positive, high-risk, early-stage breast cancer. The study included previously untreated adult patients with HER2-positive (IHC 3+ or ISH+), as determined by a central laboratory using PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody and VENTANA HER2 Dual ISH DNA Probe Cocktail assay, locally advanced high-risk (lymph node positive [N1-3] or with a primary tumor stage T3-4) or inflammatory early breast cancer. Patients were excluded for a history of ILD/pneumonitis requiring treatment with steroids, ILD/pneumonitis at screening, or ECOG performance status >1. Patients were randomized 1:1:1 to receive eight cycles of neoadjuvant treatment with: ENHERTU (5.4 mg/kg once every 3 weeks) for 4 cycles followed by THP [paclitaxel (80 mg/m 2 once a week on Days 1, 8, and 15) concurrent with trastuzumab (6 mg/kg once every 3 weeks on Day 1) and pertuzumab (an initial dose of 840 mg followed by 420 mg once every 3 weeks on Day 1)] f...",
  "brand_name": "Enhertu",
  "manufacturer": "Daiichi Sankyo Inc.",
  "application_number": "BLA761139",
  "pharm_class_epc": [],
  "route": [
   "INTRAVENOUS"
  ],
  "effective_time": "20260515",
  "set_id": "7e67e73e-ddf4-4e4d-8b50-09d7514910b6",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 59860,
  "serious": 50491,
  "death": 6807,
  "hospitalization": 16691,
  "primary_suspect": 59805,
  "top_reactions": [
   [
    "Diarrhoea",
    5927
   ],
   [
    "Alopecia",
    4941
   ],
   [
    "Off Label Use",
    4475
   ],
   [
    "Nausea",
    4253
   ],
   [
    "Fatigue",
    4115
   ],
   [
    "Myelosuppression",
    3674
   ],
   [
    "Death",
    2964
   ],
   [
    "Disease Progression",
    2799
   ],
   [
    "Vomiting",
    2689
   ],
   [
    "Dyspnoea",
    2339
   ],
   [
    "Asthenia",
    2191
   ],
   [
    "Pyrexia",
    2143
   ],
   [
    "Neuropathy Peripheral",
    2012
   ],
   [
    "Neutropenia",
    1882
   ],
   [
    "Pain",
    1872
   ]
  ],
  "by_year": {
   "2019": 5117,
   "2020": 5535,
   "2021": 5298,
   "2022": 4937,
   "2023": 5575,
   "2024": 7985,
   "2025": 5124,
   "2026": 2354
  },
  "by_year_primary": {
   "2019": 5117,
   "2020": 5534,
   "2021": 5297,
   "2022": 4929,
   "2023": 5568,
   "2024": 7971,
   "2025": 5106,
   "2026": 2350
  }
 },
 "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": "19980925",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 0,
  "labeling_recent": 0,
  "sponsors": [
   "GENENTECH"
  ],
  "unapproved": false,
  "first_approval_fmt": "09/25/1998"
 },
 "trials": {
  "total": 1746,
  "completed": 705,
  "terminated": 216,
  "with_results": 418,
  "industry": 880,
  "phase3": 288,
  "results_share": 0.5929078014184397,
  "terminated_share": 0.12371134020618557
 },
 "pubmed": {
  "rct": 492,
  "meta": 164,
  "recent_rct": 169,
  "cochrane": [
   {
    "pmid": "24919460",
    "title": "Trastuzumab-containing regimens for metastatic breast cancer",
    "year": "2014"
   },
   {
    "pmid": "22513938",
    "title": "Trastuzumab containing regimens for early breast cancer",
    "year": "2012"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 5875.19,
  "records": 77,
  "by_name": [
   [
    "Herceptin",
    5875.19
   ]
  ],
  "names_checked": [
   "trastuzumab",
   "Herceptin"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 919,
  "beneficiaries": 122,
  "spend": 4692925.16,
  "by_brand": [
   {
    "brand": "Herceptin",
    "claims": 919,
    "per_claim": 5106.5562133,
    "is_generic": false
   }
  ],
  "per_claim": 5106.556213275299
 },
 "mdl": [
  {
   "number": "2700",
   "title": "Genentech, Inc., Herceptin (Trastuzumab) Marketing and Sales Practices Litigation",
   "judge": "Frizzell, Gregory K.",
   "court": "OKN",
   "docket": "4:16-md-2700",
   "actions": "",
   "matched": "herceptin"
  }
 ],
 "dsc": [
  {
   "date": "20130506",
   "title": "FDA warns about potential medication errors resulting from confusion regarding nonproprietary name for breast cancer drug Kadcyla (ado-trastuzumab emtansine)",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm350733.htm",
   "kind": "drug",
   "matched": "trastuzumab"
  }
 ],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "trastuzumab",
  "matched": "trastuzumab",
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 57,
   "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 2013 (-8)",
    "Death share in reports is near or below the FAERS average (1.2x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 90,
   "letter": "A",
   "why": [
    "492 randomized trials and 164 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "2 independent Cochrane review(s) exist"
   ],
   "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": 60,
   "letter": "D",
   "why": [
    "Pharma paid doctors $5,875 tied to this drug last year: negligible",
    "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)",
    "5 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 73,
 "grade": "C",
 "questions": [
  "In 2013 the FDA issued a safety communication about this drug (FDA warns about potential medication errors resulting from confusion regarding nonproprietary name for breast ). 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 diarrhoea, alopecia, nausea. 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 ado-trastuzumab emtansine, margetuximab, pertuzumab? 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?",
  "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.)"
 ]
}