{
 "query": "eculizumab",
 "ingredient": "eculizumab",
 "slug": "eculizumab",
 "rxcui": "591781",
 "brands": [
  "Soliris"
 ],
 "names": [
  "eculizumab"
 ],
 "classes": [
  {
   "id": "L04AJ",
   "name": "Complement inhibitors"
  }
 ],
 "alternatives": [
  "avacopan",
  "crovalimab",
  "danicopan",
  "iptacopan",
  "pegcetacoplan",
  "pozelimab",
  "ravulizumab",
  "sutimlimab",
  "vilobelimab",
  "zilucoplan"
 ],
 "label": {
  "route_mode": "INTRAVENOUS",
  "route_counts": {
   "INTRAVENOUS": 3
  },
  "boxed_warning": "WARNING: SERIOUS MENINGOCOCCAL INFECTIONS Eculizumab products, complement inhibitors, increase the risk of serious infections caused by Neisseria meningitidis [see Warnings and Precautions (5.1) ] . Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early. Complete or update vaccination for meningococcal bacteria (for serogroups A, C, W, Y, and B) at least 2 weeks prior to the first dose of BKEMV, unless the risks of delaying therapy with BKEMV outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against meningococcal bacteria in patients receiving a complement inhibitor. See Warnings and Precautions (5.1) for additional guidance on the management of the risk of serious infections caused by meningococcal bacteria. Patients receiving eculizumab products are at increased risk for invasive disease caused by Neisseria meningitidis , even if they develop antibodies following vaccination. Monitor patients for early signs an...",
  "indications_and_usage": "is a complement inhibitor indicated for: The treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. ( 1.1 ) The treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. ( 1.2 ) Limitation of Use BKEMV is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). The treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. ( 1.3 ) The treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. ( 1.4 ) 1.1 Paroxysmal Nocturnal Hemoglobinuria (PNH) BKEMV is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. 1.2 Atypical Hemolytic Uremic Syndrome (aHUS) BKEMV is indicated for the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. Limitation of Use BKEMV is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome...",
  "contraindications": "is contraindicated for initiation in patients with unresolved serious Neisseria meningitidis infection [see Warnings and Precautions (5.1) ] . BKEMV is contraindicated for initiation in patients with unresolved serious Neisseria meningitidis infection. ( 4 )",
  "warnings_and_cautions": "Use caution when administering BKEMV to patients with any other systemic infection. ( 5.3 ) Infusion-Related Reactions: Monitor patients during infusion, interrupt for reactions, and institute appropriate supportive measures. ( 5.6 ) 5.1 Serious Meningococcal Infections Eculizumab products, complement inhibitors, increase a patient's susceptibility to serious, life-threatening, or fatal infections caused by meningococcal bacteria (septicemia and/or meningitis) in any serogroup, including non-groupable strains. Life-threatening and fatal meningococcal infections have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors. The initiation of BKEMV treatment is contraindicated in patients with unresolved serious Neisseria meningitidis infection. Complete or update meningococcal vaccination (for serogroups A, C, W, Y and B) at least 2 weeks prior to administration of the first dose of BKEMV, according to current ACIP recommendations for patients receiving a complement inhibitor. Revaccinate patients in accordance with ACIP recommendations considering the duration of therapy with BKEMV. Note that ACIP recommends an administration schedule in patients rec...",
  "warnings": "",
  "adverse_reactions": "The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Serious Meningococcal Infections [see Warnings and Precautions (5.1) ] Other Infections [see Warnings and Precautions (5.3) ] Monitoring Disease Manifestations after BKEMV Discontinuation [see Warnings and Precautions (5.4) ] Thrombosis Prevention and Management [see Warnings and Precautions (5.5) ] Infusion-Related Reactions [see Warnings and Precautions (5.6) ] The most frequently reported adverse reactions in the PNH randomized trial (\u2265 10% overall and greater than placebo) are: headache, nasopharyngitis, back pain, and nausea. ( 6.1 ) The most frequently reported adverse reactions in aHUS single arm prospective trials (\u2265 20%) are: headache, diarrhea, hypertension, upper respiratory infection, abdominal pain, vomiting, nasopharyngitis, anemia, cough, peripheral edema, nausea, urinary tract infections, pyrexia. ( 6.1 ) The most frequently reported adverse reaction in the gMG placebo-controlled clinical trial (\u2265 10%) in adult patients is musculoskeletal pain. ( 6.1 ) The most frequently reported adverse reactions in the NMOSD placebo-controlled trial (\u2265 10%) are: upper respir...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Indications and Usage ( 1.4 ) 06/2026 Dosage and Administration, ( 2.3 ) 06/2026 Dosage and Administration, ( 2.4 ) 11/2025 Dosage and Administration, ( 2.5 ) 06/2026",
  "information_for_patients": "Advise the patients and/or caregivers to read the FDA-approved patient labeling (Medication Guide). Serious Meningococcal Infections Advise patients of the risk of serious meningococcal infection. Inform patients of the need to complete or update their meningococcal vaccinations at least 2 weeks prior to receiving the first dose of BKEMV or receive antibacterial drug prophylaxis if BKEMV treatment must be initiated immediately and they have not been previously vaccinated. Inform patients of the requirement to be revaccinated according to current ACIP recommendations for meningococcal infection while on BKEMV therapy [see Warnings and Precautions (5.1) ] . Inform patients that vaccination may not prevent serious meningococcal infection and to seek immediate medical attention if the following signs or symptoms occur [see Warnings and Precautions (5.1) ] : fever fever and a rash fever with high heart rate headache with nausea or vomiting headache and a fever headache with a stiff neck or stiff back confusion muscle aches with flu-like symptoms eyes sensitive to light Inform patients that they will be given a Patient Safety Card for BKEMV that they should carry with them at all times d...",
  "spl_medguide": "This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised 06/2026 MEDICATION GUIDE BKEMV \u00ae (bee-KEM-vee) (eculizumab-aeeb) injection, for intravenous use What is the most important information I should know about BKEMV? BKEMV is a medicine that affects your immune system. BKEMV may lower the ability of your immune system to fight infections. BKEMV increases your chance of getting serious meningococcal infections caused by Neisseria meningitidis bacteria. Meningococcal infections may quickly become life-threatening or cause death if not recognized and treated early. You must complete or update your meningococcal vaccine(s) at least 2 weeks before your first dose of BKEMV. If you have not completed your meningococcal vaccines and BKEMV must be started right away, you should receive the required vaccine(s) as soon as possible. If you have not been vaccinated and BKEMV must be started right away, you should also receive antibiotics to take for as long as your healthcare provider tells you. If you had a meningococcal vaccine in the past, you might need additional vaccines before starting BKEMV. Your healthcare provider will decide if you need additional m...",
  "clinical_studies": "14.1 Paroxysmal Nocturnal Hemoglobinuria (PNH) The safety and efficacy of eculizumab in PNH patients with hemolysis were assessed in a randomized, double-blind, placebo-controlled 26-week study (PNH Study 1, NCT00122330); PNH patients were also treated with eculizumab in a single arm 52-week study (PNH Study 2, NCT00122304) and in a long-term extension study (E05-001, NCT00122317). Patients received meningococcal vaccination prior to receipt of eculizumab. In all studies, the dose of eculizumab was 600 mg study drug every 7 \u00b1 2 days for 4 weeks, followed by 900 mg 7 \u00b1 2 days later, then 900 mg every 14 \u00b1 2 days for the study duration. Eculizumab was administered as an intravenous infusion over 25 - 45 minutes. PNH Study 1: PNH patients with at least four transfusions in the prior 12 months, flow cytometric confirmation of at least 10% PNH cells and platelet counts of at least 100,000/microliter were randomized to either eculizumab (n = 43) or placebo (n = 44). Prior to randomization, all patients underwent an initial observation period to confirm the need for RBC transfusion and to identify the hemoglobin concentration (the \"set-point\") which would define each patient's hemoglobin ...",
  "brand_name": "BKEMV",
  "manufacturer": "Amgen Inc",
  "application_number": "BLA761333",
  "pharm_class_epc": [
   "Complement Inhibitor [EPC]"
  ],
  "route": [
   "INTRAVENOUS"
  ],
  "effective_time": "20260702",
  "set_id": "002f9748-b0e8-4b6e-a38b-56930a839491",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": true
 },
 "faers": {
  "total": 46862,
  "serious": 28610,
  "death": 5081,
  "hospitalization": 13297,
  "primary_suspect": 46858,
  "top_reactions": [
   [
    "Fatigue",
    4994
   ],
   [
    "Off Label Use",
    4686
   ],
   [
    "Haemoglobin Decreased",
    3097
   ],
   [
    "Headache",
    2782
   ],
   [
    "Death",
    2477
   ],
   [
    "Pyrexia",
    2024
   ],
   [
    "Dyspnoea",
    1900
   ],
   [
    "Drug Ineffective",
    1825
   ],
   [
    "Asthenia",
    1803
   ],
   [
    "Nausea",
    1633
   ],
   [
    "Malaise",
    1622
   ],
   [
    "Platelet Count Decreased",
    1546
   ],
   [
    "Haemolysis",
    1542
   ],
   [
    "Hospitalisation",
    1361
   ],
   [
    "Blood Lactate Dehydrogenase Increased",
    1313
   ]
  ],
  "by_year": {
   "2019": 6653,
   "2020": 2348,
   "2021": 2051,
   "2022": 2079,
   "2023": 2750,
   "2024": 2743,
   "2025": 2010,
   "2026": 1188
  },
  "by_year_primary": {
   "2019": 6653,
   "2020": 2348,
   "2021": 2051,
   "2022": 2076,
   "2023": 2750,
   "2024": 2743,
   "2025": 2010,
   "2026": 1188
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class I",
   "date": "20140602",
   "reason": "Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition.",
   "firm": "Alexion Pharmaceuticals, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class I",
   "date": "20131104",
   "reason": "Presence of Particulate Matter: Failed the appearance test for the presence of visible particles.",
   "firm": "Alexion Pharmaceuticals, Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 2,
 "drugsfda": {
  "applications": 1,
  "nda": 0,
  "anda": 0,
  "first_approval": "20070316",
  "rems": true,
  "rems_last": "20260601",
  "labeling_supplements": 0,
  "labeling_recent": 0,
  "sponsors": [
   "ALEXION PHARM"
  ],
  "unapproved": false,
  "first_approval_fmt": "03/16/2007"
 },
 "trials": {
  "total": 157,
  "completed": 91,
  "terminated": 23,
  "with_results": 60,
  "industry": 115,
  "phase3": 51,
  "results_share": 0.6593406593406593,
  "terminated_share": 0.1464968152866242
 },
 "pubmed": {
  "rct": 51,
  "meta": 23,
  "recent_rct": 28,
  "cochrane": [
   {
    "pmid": "25356860",
    "title": "Eculizumab for treating patients with paroxysmal nocturnal hemoglobinuria",
    "year": "2014"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 531178.08,
  "records": 2120,
  "by_name": [
   [
    "Soliris",
    531178.08
   ]
  ],
  "names_checked": [
   "eculizumab",
   "Soliris"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 4569,
  "beneficiaries": 419,
  "spend": 196193578.99,
  "by_brand": [
   {
    "brand": "Soliris",
    "claims": 4569,
    "per_claim": 42940.157363,
    "is_generic": false
   }
  ],
  "per_claim": 42940.15736266142
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 35,
   "letter": "F",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "Subject to a REMS safety program: FDA requires special controls to use it (-10)",
    "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)",
    "2 Class I recall(s): reasonable probability of serious harm (-20)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 60,
   "letter": "D",
   "why": [
    "51 randomized trials and 23 systematic reviews/meta-analyses indexed in PubMed",
    "1 independent Cochrane review(s) exist"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 85,
   "letter": "B",
   "why": [
    "No recalls on record since 2016",
    "REMS program in force (-10)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 85,
   "letter": "B",
   "why": [
    "Pharma paid doctors $531,178 tied to this drug last year (-15)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "No generic version approved: brand-only pricing (-30)",
    "10 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 60,
 "grade": "D",
 "questions": [
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "This drug has a REMS safety program. What monitoring does that require from us?",
  "The most-reported problems in FDA's adverse event data are fatigue, haemoglobin decreased, headache. 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 avacopan, crovalimab, danicopan? 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.)"
 ]
}