{
 "query": "tezepelumab",
 "ingredient": "tezepelumab",
 "slug": "tezepelumab",
 "rxcui": "2587789",
 "brands": [],
 "names": [
  "tezepelumab"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "SUBCUTANEOUS",
  "route_counts": {
   "SUBCUTANEOUS": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "is a thymic stromal lymphopoietin (TSLP) blocker, human monoclonal antibody (IgG2\u03bb), indicated: \u2022 for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. ( 1.1 ) Limitations of Use: Not for relief of acute bronchospasm or status asthmaticus. ( 1.1 ) \u2022 for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). ( 1.2 ) 1.1 Asthma TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. Limitations of Use: TEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus. 1.2 Chronic Rhinosinusitis with Nasal Polyps TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).",
  "contraindications": "is contraindicated in patients who have known hypersensitivity to tezepelumab-ekko or any of its excipients [see Warnings and Precautions (5.1) ] . Known hypersensitivity to tezepelumab-ekko or excipients. ( 4 )",
  "warnings_and_cautions": "\u2022 Hypersensitivity Reactions: Hypersensitivity reactions have been observed in the clinical trials (e.g., rash, allergic conjunctivitis) following the administration of TEZSPIRE. Postmarketing cases of anaphylaxis have been reported. Initiate appropriate treatment as clinically indicated in the event of a hypersensitivity reaction. ( 5.1 ) \u2022 Risk Associated with Abrupt Reduction in Corticosteroid Dosage: Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with TEZSPIRE. Decrease corticosteroids gradually, if appropriate. ( 5.3 ) \u2022 Parasitic (Helminth) Infection: Treat patients with pre-existing helminth infections before therapy with TEZSPIRE. If patients become infected while receiving TEZSPIRE and do not respond to anti-helminth treatment, discontinue TEZSPIRE until the parasitic infection resolves. ( 5.4 ) \u2022 Vaccination: Avoid use of live attenuated vaccines. ( 5.5 ) 5.1 Hypersensitivity Reactions Hypersensitivity reactions were observed in the clinical trials (e.g., rash and allergic conjunctivitis) following the administration of TEZSPIRE. Postmarketing cases of anaphylaxis have also been reported [see Contraindications (4) and Adverse Re...",
  "warnings": "",
  "adverse_reactions": "The following clinically significant adverse reactions are described elsewhere in the labeling: \u2022 Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Most common adverse reactions (incidence \u2265 3%) are: \u2022 Asthma: pharyngitis, arthralgia, and back pain. ( 6.1 ) \u2022 Chronic rhinosinusitis with nasal polyps: nasopharyngitis, upper respiratory tract infection, epistaxis, pharyngitis, back pain, influenza, injection site reaction and arthralgia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 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 in Adult and Pediatric Patients 12 Years of Age and Older with Asthma The safety of TEZSPIRE in asthma was based on the pooled safety population from PATHWAY and NAVIGATOR, which consists of 665 adult and pediatric patients 12 years of age and older with severe asthma who received at least one do...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Indications and Usage ( 1.2 ) 10/2025",
  "information_for_patients": "Advise the patient and/or caregiver to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Hypersensitivity Reactions Inform patients that hypersensitivity reactions (e.g., anaphylaxis, rash and allergic conjunctivitis) can occur following administration of TEZSPIRE [ see Contraindications (4) and Adverse Reactions (6) ] . These reactions can occur within hours of administration, but in some instances have a delayed onset (i.e., days). Instruct patients to contact their healthcare provider if they experience symptoms of an allergic reaction [see Warnings and Precautions (5.1) ] . Not for Acute Symptoms or Deteriorating Disease Inform patients that TEZSPIRE does not treat acute asthma symptoms or acute exacerbations. Inform patients to seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment with TEZSPIRE [see Warnings and Precautions (5.2) ] . Risk Associated with Abrupt Reduction of Corticosteroid Dosage Inform patients to not discontinue systemic or inhaled corticosteroids except under the direct supervision of a healthcare provider. Inform patients that reduction in corticosteroid dose may be associated ...",
  "spl_medguide": "",
  "clinical_studies": "14.1 Clinical Studies in Patients with Asthma The efficacy of TEZSPIRE for add-on maintenance treatment of severe asthma was evaluated in two randomized, double-blind, parallel group, placebo-controlled clinical trials (PATHWAY [NCT02054130] and NAVIGATOR [NCT03347279]) of 52 weeks duration. The two trials enrolled a total of 1,609 patients 12 years of age and older with severe asthma. PATHWAY was a 52-week dose-ranging exacerbation trial that enrolled 550 adult patients with severe asthma who received treatment with tezepelumab-ekko 70 mg subcutaneously every 4 weeks, TEZSPIRE 210 mg subcutaneously every 4 weeks, tezepelumab-ekko 280 mg subcutaneously every 2 weeks, or placebo subcutaneously. Patients were required to have a history of 2 or more asthma exacerbations requiring oral or injectable corticosteroid treatment or 1 asthma exacerbation resulting in hospitalization in the past 12 months. NAVIGATOR was a 52-week exacerbation trial that enrolled 1,061 patients (adult and pediatric patients 12 years of age and older) with severe asthma who received treatment with TEZSPIRE 210 mg subcutaneously every 4 weeks or placebo subcutaneously every 4 weeks. Patients were required to hav...",
  "brand_name": "TEZSPIRE",
  "manufacturer": "Amgen Inc",
  "application_number": "BLA761224",
  "pharm_class_epc": [
   "Thymic Stromal Lymphopoietin Blocker [EPC]"
  ],
  "route": [
   "SUBCUTANEOUS"
  ],
  "effective_time": "20251017",
  "set_id": "60f0aa03-ad25-4d48-80ce-7fcfa76f325f",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 2211,
  "serious": 2042,
  "death": 235,
  "hospitalization": 807,
  "primary_suspect": 2210,
  "top_reactions": [
   [
    "Asthma",
    337
   ],
   [
    "Pneumonia",
    332
   ],
   [
    "Dyspnoea",
    289
   ],
   [
    "Death",
    196
   ],
   [
    "Cough",
    163
   ],
   [
    "Wheezing",
    130
   ],
   [
    "Lower Respiratory Tract Infection",
    125
   ],
   [
    "Drug Ineffective",
    120
   ],
   [
    "Fall",
    85
   ],
   [
    "Fatigue",
    71
   ],
   [
    "Illness",
    71
   ],
   [
    "Product Dose Omission Issue",
    69
   ],
   [
    "Arthralgia",
    68
   ],
   [
    "Headache",
    65
   ],
   [
    "Chronic Obstructive Pulmonary Disease",
    61
   ]
  ],
  "by_year": {
   "2019": 1,
   "2020": 3,
   "2021": 7,
   "2022": 23,
   "2023": 57,
   "2024": 364,
   "2025": 948,
   "2026": 807
  },
  "by_year_primary": {
   "2019": 1,
   "2020": 3,
   "2021": 7,
   "2022": 23,
   "2023": 57,
   "2024": 364,
   "2025": 947,
   "2026": 807
  }
 },
 "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": 73,
  "completed": 33,
  "terminated": 2,
  "with_results": 23,
  "industry": 56,
  "phase3": 23,
  "results_share": 0.696969696969697,
  "terminated_share": 0.0273972602739726
 },
 "pubmed": {
  "rct": 37,
  "meta": 9,
  "recent_rct": 29,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "tezepelumab"
  ],
  "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": [
    "Death share in reports is near or below the FAERS average (1.2x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 47,
   "letter": "F",
   "why": [
    "37 randomized trials and 9 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": 80,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are asthma, pneumonia, dyspnoea, death. 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.)"
 ]
}