{
 "query": "inclisiran",
 "ingredient": "inclisiran",
 "slug": "inclisiran",
 "rxcui": "2588243",
 "brands": [
  "Leqvio"
 ],
 "names": [
  "inclisiran",
  "inclisiran sodium"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "SUBCUTANEOUS",
  "route_counts": {
   "SUBCUTANEOUS": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "\u00ae is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in: adults with hypercholesterolemia. adults and pediatric patients aged 12 years and older with heterozygous familial hypercholesterolemia (HeFH). pediatric patients aged 12 years and older with homozygous familial hypercholesterolemia (HoFH). Cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE) in adults at increased risk when treated with statins or monoclonal antibody proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors as an add-on to statin therapy. LEQVIO is a small interfering RNA (siRNA) directed to proprotein convertase subtilisin kexin type 9 (PCSK9) mRNA indicated 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 12 years and older with heterozygous familial hypercholesterolemia (HeFH). ( 1 ) pediatric patients aged 12 years and older with homozygous familial hypercholesterolemia (HoFH). ( 1 ) Cardiovascular outcomes trials have demonstrated that reducing LDL-C l...",
  "contraindications": "is contraindicated in patients with a prior serious hypersensitivity reaction to inclisiran or any of the excipients in LEQVIO. Serious hypersensitivity reactions have included anaphylaxis and angioedema [see Adverse Reactions (6.2)] . Prior serious hypersensitivity reaction to inclisiran or any of the excipients in LEQVIO.",
  "warnings_and_cautions": "Hypersensitivity Reactions: Have been reported in patients treated with LEQVIO. Advise patients on the signs and symptoms of hypersensitivity reactions and instruct patients to seek medical attention promptly. ( 5.1 ) 5.1 Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported in patients treated with LEQVIO [see Adverse Reactions (6.2)] . Advise patients on the signs and symptoms of hypersensitivity reactions and instruct patients to seek medical attention promptly. LEQVIO is contraindicated in patients with a prior serious hypersensitivity reaction to inclisiran or any of the excipients in LEQVIO.",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are also discussed in other sections of the label: Hypersensitivity Reactions [see Warnings and Precautions (5.1)] Common adverse reactions in clinical trials (\u2265 3%): injection site reaction, arthralgia, and bronchitis. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 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 3 placebo-controlled trials that included 1,833 adults with hypercholesterolemia treated with LEQVIO, including 1,682 exposed for 18 months (median treatment duration of 77 weeks) [see Clinical Studies (14)] . The mean age of the population was 64 years, 32% of the population were female, 92% were White, 6% were Black or African American, 1% were Asian, and < 1% were other races; 6% identified as Hisp...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Indications and Usage ( 1 ) 02/2026 Contraindications ( 4 ) 02/2026 Warnings and Precautions ( 5.1 ) 02/2026",
  "information_for_patients": "Pregnancy Advise pregnant patients and patients who can become pregnant of the potential risk to a fetus. Advise patients to inform their healthcare provider of a known or suspected pregnancy to discuss if LEQVIO should be discontinued [see Use in Specific Populations (8.1)] . Advise women who are exposed to LEQVIO during pregnancy that there is a pregnancy safety study that monitors pregnancy outcomes. Encourage these patients to report their pregnancy to Novartis at 1-888-669-6682 or usdrugsafety.operations@novartis.com [see Use in Specific Populations (8.1)] . Hypersensitivity Inform patients that serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported in patients treated with LEQVIO. Advise patients on the signs and symptoms of hypersensitivity reactions and instruct them to seek medical advice promptly if such symptoms occur [see Warnings and Precautions (5.1)] . Injection Site Reactions Advise patients that injection site reactions can occur with LEQVIO [see Adverse Reactions (6.1)] . Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 For more information, visit www.leqvio.com or call 1-833-LEQVIO2 (1-833-5...",
  "spl_medguide": "",
  "clinical_studies": "Adults with Primary Hypercholesterolemia or HeFH The efficacy of LEQVIO was investigated in three randomized, double-blind, placebo-controlled trials that enrolled 3,660 adults with HeFH, clinical ASCVD, or increased risk for ASCVD, who were taking maximally tolerated statin therapy and who required additional LDL-C lowering. Demographics and baseline disease characteristics were balanced between the treatment arms in all trials. Adults with Primary Hypercholesterolemia Trial 1 (ORION-10, NCT03399370) was a multicenter, double-blind, randomized, placebo-controlled 18-month trial in which 1,561 adults with ASCVD were randomized 1:1 to receive subcutaneous injections of either LEQVIO 284 mg (n = 781) or placebo (n = 780) on Day 1, Day 90, Day 270, and at Day 450. Patients were taking a maximally tolerated dose of statin with or without other lipid modifying therapy and required additional LDL-C reduction. Patients were stratified by current use of statins or other lipid-modifying therapies. Patients taking PCSK9 inhibitors were excluded from the trial. The mean age at baseline was 66 years (range: 35 to 90 years), 60% were \u226565 years old, 31% were female, 86% were White, 13% were Blac...",
  "brand_name": "LEQVIO",
  "manufacturer": "Novartis Pharmaceuticals Corporation",
  "application_number": "NDA214012",
  "pharm_class_epc": [],
  "route": [
   "SUBCUTANEOUS"
  ],
  "effective_time": "20260819",
  "set_id": "6fc0afca-4513-4c35-b594-6544aee29a44",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 7979,
  "serious": 3366,
  "death": 226,
  "hospitalization": 794,
  "primary_suspect": 7962,
  "top_reactions": [
   [
    "Arthralgia",
    846
   ],
   [
    "Myalgia",
    662
   ],
   [
    "Injection Site Pain",
    568
   ],
   [
    "Low Density Lipoprotein Increased",
    503
   ],
   [
    "Pain In Extremity",
    485
   ],
   [
    "Fatigue",
    410
   ],
   [
    "Pain",
    410
   ],
   [
    "Drug Ineffective",
    409
   ],
   [
    "Diarrhoea",
    362
   ],
   [
    "Dyspnoea",
    360
   ],
   [
    "Headache",
    301
   ],
   [
    "Rash",
    275
   ],
   [
    "Muscle Spasms",
    254
   ],
   [
    "Cough",
    234
   ],
   [
    "Blood Cholesterol Increased",
    226
   ]
  ],
  "by_year": {
   "2019": 1,
   "2020": 1,
   "2021": 33,
   "2022": 910,
   "2023": 2224,
   "2024": 1907,
   "2025": 1937,
   "2026": 965
  },
  "by_year_primary": {
   "2019": 1,
   "2020": 1,
   "2021": 33,
   "2022": 910,
   "2023": 2221,
   "2024": 1901,
   "2025": 1929,
   "2026": 965
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 1,
  "nda": 1,
  "anda": 0,
  "first_approval": "20211222",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 6,
  "labeling_recent": 5,
  "sponsors": [
   "NOVARTIS"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/22/2021"
 },
 "trials": {
  "total": 82,
  "completed": 34,
  "terminated": 2,
  "with_results": 17,
  "industry": 66,
  "phase3": 24,
  "results_share": 0.5,
  "terminated_share": 0.024390243902439025
 },
 "pubmed": {
  "rct": 26,
  "meta": 23,
  "recent_rct": 20,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 2703913.82,
  "records": 130072,
  "by_name": [
   [
    "Leqvio",
    2703913.82
   ]
  ],
  "names_checked": [
   "inclisiran",
   "Leqvio"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 4425,
  "beneficiaries": 2681,
  "spend": 14379722.52,
  "by_brand": [
   {
    "brand": "Leqvio",
    "claims": 4425,
    "per_claim": 3249.6548068,
    "is_generic": false
   }
  ],
  "per_claim": 3249.6548067796607
 },
 "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 (0.3x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 50,
   "letter": "D",
   "why": [
    "26 randomized trials and 23 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 77,
   "letter": "B",
   "why": [
    "No recalls on record since 2016",
    "5 label changes approved since 2021: the safety story is still moving (-8)",
    "Label lists recent major changes to warnings or indications (-5)",
    "Approved within the last 5 years: long-term safety is not yet known (-10)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 70,
   "letter": "C",
   "why": [
    "Pharma paid doctors $2,703,914 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": 74,
 "grade": "C",
 "questions": [
  "The most-reported problems in FDA's adverse event data are arthralgia, myalgia, injection site pain, low density lipoprotein increased. 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.)"
 ]
}