{
 "query": "benralizumab",
 "ingredient": "benralizumab",
 "slug": "benralizumab",
 "rxcui": "1989100",
 "brands": [
  "Fasenra"
 ],
 "names": [
  "benralizumab"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "SUBCUTANEOUS",
  "route_counts": {
   "SUBCUTANEOUS": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody (IgG1, kappa) indicated for: \u2022 add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma, and with an eosinophilic phenotype. ( 1.1 ) \u2022 treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). ( 1.2 ) \u2022 treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) without an identifiable non-hematologic secondary cause. ( 1.3 ) Limitations of Use : Not for relief of acute bronchospasm or status asthmaticus. (1.1) 1.1 Asthma FASENRA is indicated for the add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma, and with an eosinophilic phenotype. Limitations of Use: \u2022 FASENRA is not indicated for the relief of acute bronchospasm or status asthmaticus. 1.2 Eosinophilic Granulomatosis with Polyangiitis FASENRA is indicated for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). 1.3 Hypereosinophilic Syndrome FASENRA is indicated for the treatment of adult and pediatric patients aged 12 years and older with hypereos...",
  "contraindications": "is contraindicated in patients who have known hypersensitivity to benralizumab or any of its excipients [see Warnings and Precautions (5.1) ] . Known hypersensitivity to benralizumab or excipients. (4)",
  "warnings_and_cautions": "\u2022 Hypersensitivity reactions: Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, rash) have occurred after administration of FASENRA. Discontinue in the event of a hypersensitivity reaction. (5.1) \u2022 Reduction in Corticosteroid Dosage: Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with FASENRA. Decrease corticosteroids gradually, if appropriate. (5.3) \u2022 Parasitic (Helminth) Infection: Treat patients with pre-existing helminth infections before therapy with FASENRA. If patients become infected while receiving FASENRA and do not respond to anti-helminth treatment, discontinue FASENRA until the parasitic infection resolves. (5.4) 5.1 Hypersensitivity Reactions Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, rash) have occurred following administration of FASENRA. These reactions generally occur within hours of administration, but in some instances have a delayed onset (i.e., days). In the event of a hypersensitivity reaction, FASENRA should be discontinued [see Contraindications (4) ] . 5.2 Acute Asthma Symptoms or Deteriorating Disease FASENRA should not be used to treat acute asthma symptoms or acut...",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are described in greater detail in other sections: \u2022 Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Most common adverse reactions (incidence greater than or equal to 5%): \u2022 Asthma: headache and pharyngitis. ( 6.1 ) \u2022 EGPA: headache. ( 6.1 ) \u2022 HES: headache, hypersensitivity reactions, and influenza-like illness. ( 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. Adult and Pediatric Patients 12 Years of Age and Older with Asthma Across three clinical trials (SIROCCO, CALIMA, and ZONDA) for asthma, 1,808 patients received at least 1 dose of FASENRA [see Clinical Studies (14.1) ] . The data described below reflect exposure to FASENRA in 1,663 patients, including 1,556 exposed for at least 24 weeks and 1,387 exposed for at least 48 weeks. The safety exposure for FA...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Indications and Usage ( 1.3 ) 05/2026 Dosage and Administration ( 2.3 ) 05/2026",
  "information_for_patients": "Advise the patients and/or caregivers to read the FDA-approved patient labeling (Patient Information and Instructions for Use for FASENRA PEN) before the patient starts using FASENRA and each time the prescription is renewed as there may be new information they need to know. Administration Instructions Instruct patients and/or caregivers on proper subcutaneous injection technique using the FASENRA PEN, including aseptic technique, and the preparation and administration of FASENRA PEN prior to use. Advise patients to follow sharps disposal recommendations [see Instructions for Use]. Hypersensitivity Reactions Inform patients that hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, rash) have occurred after administration of FASENRA. These reactions generally occurred within hours of FASENRA administration, but in some instances had 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 FASENRA does not treat acute asthma symptoms or acute exacerbations. Inform patients to seek m...",
  "spl_medguide": "",
  "clinical_studies": "14.1 Clinical Studies in Patients with Asthma The efficacy of FASENRA for the add-on maintenance treatment of severe asthma and with an eosinophilic phenotype was evaluated in two randomized, double-blind, parallel-group, placebo-controlled, exacerbation trials, SIROCCO (NCT01928771) and CALIMA (NCT01914757), for 48 and 56 weeks in duration, respectively. Furthermore, the effects of FASENRA in the reduction of oral corticosteroid use and effect on lung function were evaluated in clinical trials, ZONDA (NCT02075255) and a 12-week lung function trial (NCT02322775), respectively. SIROCCO and CALIMA were randomized, double-blind, parallel-group, placebo-controlled, exacerbation trials in patients 12 years of age and older, and 48 and 56 weeks in duration, respectively. The trials randomized a total of 2,510 patients. Patients were required to have a history of 2 or more asthma exacerbations requiring oral or systemic corticosteroid treatment in the past 12 months, Asthma Control Questionnaire-6 (ACQ\u20116) score of 1.5 or more at screening, and reduced lung function at baseline [pre-bronchodilator FEV 1 below 80% in adults, and below 90% in pediatric patients aged 12 to 17 years] despite r...",
  "brand_name": "FASENRA",
  "manufacturer": "AstraZeneca Pharmaceuticals LP",
  "application_number": "BLA761070",
  "pharm_class_epc": [
   "Interleukin-5 Receptor alpha-directed Cytolytic Antibody [EPC]"
  ],
  "route": [
   "SUBCUTANEOUS"
  ],
  "effective_time": "20260513",
  "set_id": "da6aca1a-19ed-44a4-abb7-696c7d58b784",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 19921,
  "serious": 12752,
  "death": 2005,
  "hospitalization": 4812,
  "primary_suspect": 19916,
  "top_reactions": [
   [
    "Asthma",
    3007
   ],
   [
    "Dyspnoea",
    1999
   ],
   [
    "Death",
    1646
   ],
   [
    "Drug Ineffective",
    1519
   ],
   [
    "Pneumonia",
    1086
   ],
   [
    "Cough",
    1054
   ],
   [
    "Product Dose Omission Issue",
    1003
   ],
   [
    "Headache",
    934
   ],
   [
    "Wheezing",
    748
   ],
   [
    "Fatigue",
    641
   ],
   [
    "Malaise",
    622
   ],
   [
    "Inappropriate Schedule Of Product Administration",
    591
   ],
   [
    "Arthralgia",
    560
   ],
   [
    "Pyrexia",
    544
   ],
   [
    "Rash",
    516
   ]
  ],
  "by_year": {
   "2019": 1650,
   "2020": 1709,
   "2021": 2103,
   "2022": 1827,
   "2023": 2296,
   "2024": 3669,
   "2025": 3546,
   "2026": 2169
  },
  "by_year_primary": {
   "2019": 1650,
   "2020": 1709,
   "2021": 2103,
   "2022": 1825,
   "2023": 2295,
   "2024": 3668,
   "2025": 3545,
   "2026": 2169
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20251008",
   "reason": "Lack of Assurance of Sterility:",
   "firm": "ASTRAZENECA PHARMACEUTICALS",
   "status": "Ongoing"
  }
 ],
 "recall_total": 1,
 "drugsfda": {
  "applications": 1,
  "nda": 0,
  "anda": 0,
  "first_approval": "20171114",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 0,
  "labeling_recent": 0,
  "sponsors": [
   "ASTRAZENECA AB"
  ],
  "unapproved": false,
  "first_approval_fmt": "11/14/2017"
 },
 "trials": {
  "total": 121,
  "completed": 68,
  "terminated": 13,
  "with_results": 45,
  "industry": 92,
  "phase3": 38,
  "results_share": 0.6617647058823529,
  "terminated_share": 0.10743801652892562
 },
 "pubmed": {
  "rct": 54,
  "meta": 14,
  "recent_rct": 30,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 4024141.35,
  "records": 37903,
  "by_name": [
   [
    "Fasenra",
    4024141.35
   ]
  ],
  "names_checked": [
   "benralizumab",
   "Fasenra"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 53831,
  "beneficiaries": 11576,
  "spend": 307509397.6,
  "by_brand": [
   {
    "brand": "Fasenra Pen",
    "claims": 40692,
    "per_claim": 5692.7737204,
    "is_generic": false
   },
   {
    "brand": "Fasenra",
    "claims": 13139,
    "per_claim": 5773.578611,
    "is_generic": false
   }
  ],
  "per_claim": 5712.496472292917
 },
 "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 (1.1x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 53,
   "letter": "D",
   "why": [
    "54 randomized trials and 14 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 92,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 0 Class III (-3)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 70,
   "letter": "C",
   "why": [
    "Pharma paid doctors $4,024,141 tied to this drug last year (-30)",
    "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": 77,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are asthma, 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?",
  "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.)"
 ]
}