{
 "query": "alirocumab",
 "ingredient": "alirocumab",
 "slug": "alirocumab",
 "rxcui": "1659152",
 "brands": [
  "Praluent"
 ],
 "names": [
  "alirocumab"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "SUBCUTANEOUS",
  "route_counts": {
   "SUBCUTANEOUS": 2
  },
  "boxed_warning": "",
  "indications_and_usage": "\u00ae is indicated: To reduce the risk of major adverse cardiovascular (CV) events (coronary heart disease death, myocardial infarction, stroke, or unstable angina requiring hospitalization) in adults at increased risk for these events . As an adjunct to diet and exercise to reduce low- density lipoprotein cholesterol (LDL-C) in: adults with hypercholesterolemia. adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). adults with homozygous familial hypercholesterolemia (HoFH). PRALUENT is a proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor indicated: To reduce the risk of major adverse cardiovascular (CV) events (coronary heart disease death, myocardial infarction, stroke, or unstable angina requiring hospitalization) in adults at increased risk for these events. ( 1 ) As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in : adults with hypercholesterolemia ( 1 ) adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). ( 1 ) adults with homozygous familial hypercholesterolemia (HoFH). ( 1 )",
  "contraindications": "is contraindicated in patients with a history of a serious hypersensitivity reaction to alirocumab or any of the excipients in PRALUENT. Hypersensitivity vasculitis, angioedema, and hypersensitivity reactions requiring hospitalization have occurred [see Warnings and Precautions (5.1) ]. History of a serious hypersensitivity reaction to alirocumab or any of the excipients in PRALUENT. ( 4 )",
  "warnings_and_cautions": "Hypersensitivity reactions: hypersensitivity vasculitis, angioedema, and other hypersensitivity reactions requiring hospitalization, have been reported with PRALUENT treatment. If signs or symptoms of serious hypersensitivity reactions occur, discontinue treatment with PRALUENT, treat according to the standard of care, and monitor until signs and symptoms resolve. ( 5.1 ) 5.1 Hypersensitivity Reactions Hypersensitivity reactions, including hypersensitivity vasculitis, angioedema, and other hypersensitivity reactions requiring hospitalization, have been reported with PRALUENT treatment. If signs or symptoms of serious hypersensitivity reactions occur, discontinue treatment with PRALUENT, treat according to the standard of care, and monitor until signs and symptoms resolve. PRALUENT is contraindicated in patients with a history of a serious hypersensitivity reaction to alirocumab or any excipient in PRALUENT [see Contraindications (4) ] .",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are also discussed in the other sections of the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Common (>5% of patients treated with PRALUENT and more frequently than placebo) adverse reactions in adults with: Primary hypercholesterolemia : injection site reactions, and influenza. ( 6 ) Established CV disease: myalgia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Regeneron at 1-844-734-6643 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 Adults with Hypercholesterolemia The data in Table 1 are derived from 9 primary hypercholesterolemia placebo-controlled trials that included 2,476 adult patients treated with PRALUENT 75 mg and/or 150 mg every 2 weeks, including 2,135 exposed for 6 months and 1,999 exposed for more than 1 year (median treatment duration of 65 weeks). The mean age of the population was 59...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Indications and Usage ( 1 ) 10/2025",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Hypersensitivity Reactions Inform patients that serious hypersensitivity reactions (e.g., angioedema) have been reported in patients treated with PRALUENT. Advise patients on the symptoms of hypersensitivity reactions and instruct them to discontinue PRALUENT and seek medical attention promptly, if such symptoms occur [ see Warnings and Precautions (5.1) ] . Administration Provide guidance to patients and caregivers on proper subcutaneous injection technique and how to use the pre-filled pen. Inform patients that it may take up to 20 seconds to inject PRALUENT. Inform patients the pre-filled pen should be allowed to warm to room temperature for 30 to 40 minutes prior to use if refrigerated. Pregnancy Advise women who are exposed to PRALUENT during pregnancy that there is a pregnancy safety study that monitors pregnancy outcomes. Encourage these patients to report their pregnancy to Regeneron at 1 844-734-6643 [see Use in Specific Populations (8.1) ].",
  "spl_medguide": "",
  "clinical_studies": "14.1 Cardiovascular Outcome Trial in Adult Patients with Established Cardiovascular Disease Trial 1 (ODYSSEY OUTCOMES, NTC01663402) was a multicenter, double-blind, placebo-controlled trial in 18,924 adult patients (9,462 PRALUENT; 9,462 placebo) followed for up to 5 years. Patients had an acute coronary syndrome (ACS) event 4 to 52 weeks prior to randomization and were treated with a lipid-modifying therapy (LMT) regimen that was statin-intensive (defined as atorvastatin 40 or 80 mg, or rosuvastatin 20 or 40 mg) or at maximally tolerated dose of a statin, with or without other LMT. Patients were randomized to receive either PRALUENT 75 mg or placebo once every two weeks. At month 2, if additional LDL-C lowering was required based on pre-specified LDL-C criteria (LDL-C \u226550 mg/dL), PRALUENT was adjusted to 150 mg every 2 weeks. For patients who had their dose adjusted to 150 mg every 2 weeks and who had two consecutive LDL-C values below 25 mg/dL, down-titration from 150 mg every 2 weeks to 75 mg every 2 weeks was performed. Patients on 75 mg every 2 weeks who had two consecutive LDL-C values below 15 mg/dL were switched to placebo in a blinded fashion. Approximately 2,615 (27.7%) o...",
  "brand_name": "Praluent",
  "manufacturer": "Sanofi-Aventis U.S. LLC",
  "application_number": "BLA125559",
  "pharm_class_epc": [
   "PCSK9 Inhibitor [EPC]"
  ],
  "route": [
   "SUBCUTANEOUS"
  ],
  "effective_time": "20260707",
  "set_id": "446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 24967,
  "serious": 6828,
  "death": 507,
  "hospitalization": 2634,
  "primary_suspect": 24962,
  "top_reactions": [
   [
    "Myalgia",
    1687
   ],
   [
    "Product Dose Omission",
    1364
   ],
   [
    "Injection Site Pain",
    1319
   ],
   [
    "Muscle Spasms",
    1191
   ],
   [
    "Arthralgia",
    1077
   ],
   [
    "Fatigue",
    1033
   ],
   [
    "Pain",
    965
   ],
   [
    "Pain In Extremity",
    942
   ],
   [
    "Product Dose Omission Issue",
    913
   ],
   [
    "Injection Site Bruising",
    861
   ],
   [
    "Diarrhoea",
    813
   ],
   [
    "Headache",
    811
   ],
   [
    "Influenza Like Illness",
    806
   ],
   [
    "Device Issue",
    789
   ],
   [
    "Cough",
    727
   ]
  ],
  "by_year": {
   "2019": 4512,
   "2020": 2096,
   "2021": 1742,
   "2022": 1662,
   "2023": 1580,
   "2024": 1362,
   "2025": 1110,
   "2026": 499
  },
  "by_year_primary": {
   "2019": 4512,
   "2020": 2096,
   "2021": 1742,
   "2022": 1661,
   "2023": 1580,
   "2024": 1360,
   "2025": 1110,
   "2026": 497
  }
 },
 "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": "20150724",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 0,
  "labeling_recent": 0,
  "sponsors": [
   "REGENERON PHARMACEUTICALS"
  ],
  "unapproved": false,
  "first_approval_fmt": "07/24/2015"
 },
 "trials": {
  "total": 118,
  "completed": 69,
  "terminated": 8,
  "with_results": 40,
  "industry": 77,
  "phase3": 35,
  "results_share": 0.5797101449275363,
  "terminated_share": 0.06779661016949153
 },
 "pubmed": {
  "rct": 119,
  "meta": 23,
  "recent_rct": 30,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 10575.75,
  "records": 275,
  "by_name": [
   [
    "Praluent",
    10575.75
   ]
  ],
  "names_checked": [
   "alirocumab",
   "Praluent"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 442806,
  "beneficiaries": 92483,
  "spend": 340584673.39,
  "by_brand": [
   {
    "brand": "Praluent Pen",
    "claims": 442806,
    "per_claim": 769.15099025,
    "is_generic": false
   }
  ],
  "per_claim": 769.1509902530679
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 2967,
  "fills": 442806,
  "per_million": 6700.4512133981925,
  "ratio": 2.4198529439640004,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 92,
   "letter": "A",
   "why": [
    "6,700 FDA reports naming it as the suspect drug per million Medicare fills, 2.4x the median drug on this site (-8)",
    "Death share in reports is near or below the FAERS average (0.2x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 62,
   "letter": "D",
   "why": [
    "119 randomized trials and 23 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 $10,576 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": 81,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are myalgia, product dose omission, injection site pain, muscle spasms. 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.)"
 ]
}