{
 "query": "leuprolide",
 "ingredient": "leuprolide",
 "slug": "leuprolide",
 "rxcui": "42375",
 "brands": [
  "Eligard",
  "Camcevi",
  "Fensolvi",
  "Lupron",
  "Lutrate",
  "Vabrinty"
 ],
 "names": [
  "leuprolide",
  "leuprolide acetate",
  "leuprolide mesylate"
 ],
 "classes": [
  {
   "id": "L02AE",
   "name": "Gonadotropin releasing hormone analogues"
  }
 ],
 "alternatives": [
  "buserelin",
  "goserelin",
  "histrelin",
  "triptorelin"
 ],
 "label": {
  "route_mode": "SUBCUTANEOUS",
  "route_counts": {
   "SUBCUTANEOUS": 5
  },
  "boxed_warning": "",
  "indications_and_usage": "is indicated for the treatment of advanced prostate cancer. VABRINTY is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of advanced prostate cancer. ( 1 )",
  "contraindications": "Hypersensitivity VABRINTY is contraindicated in patients with hypersensitivity to GnRH, GnRH agonist analogs or any of the components of VABRINTY. Anaphylactic reactions to synthetic GnRH or GnRH agonist analogs have been reported in the literature. Known hypersensitivity to GnRH, GnRH agonist analogs or any of the components of VABRINTY ( 4 )",
  "warnings_and_cautions": "Tumor Flare: Transient increase in serum levels of testosterone during treatment may result in worsening of symptoms or onset of new signs and symptoms during the first few weeks of treatment, including bone pain, neuropathy, hematuria, bladder outlet obstruction, ureteral obstruction, or spinal cord compression. Monitor patients at risk closely and manage as appropriate. ( 5.1 , 5.7 ) Hyperglycemia and diabetes: Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH analogs. Monitor blood glucose level and manage according to current clinical practice. ( 5.2 ) Cardiovascular diseases: Increased risk of myocardial infarction, sudden cardiac death and stroke has been reported in men. Monitor for cardiovascular disease and manage according to current clinical practice. ( 5.3 ) Effect on QT/QTc Interval: Androgen deprivation therapy may prolong the QT interval. Consider risks and benefits. ( 5.4 ) Convulsions have been observed in patients with or without a history of predisposing factors. Manage convulsions according to the current clinical practice. (5.5) Severe Cutaneous Adverse Reactions (SCARs), including Stevens-Johnson syndrome/toxic...",
  "warnings": "",
  "adverse_reactions": "The following clinically significant adverse reactions are described elsewhere in the labeling: Tumor Flare [see Warnings and Precautions ( 5.1 )] Hyperglycemia and Diabetes [see Warnings and Precautions ( 5.2 )] Cardiovascular Disease [see Warnings and Precautions ( 5.3 )] Effect on QT/QTc Interval [see Warnings and Precautions ( 5.4 )] Convulsions [see Warnings and Precautions ( 5.5 )] Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5. 6 )] Most common adverse reactions in clinical studies (incidence \u2265 5%): Malaise, fatigue, hot flashes/sweats, and testicular atrophy. ( 6.1 ) As with other GnRH agonists, other adverse reactions, including decreased bone density and rare cases of pituitary apoplexy have been reported. ( 6.1 , 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Uronova Pharmaceuticals, Inc. at 877-712-4575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial 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. T...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "RECENT MAJOR CHANGES Warnings and Precautions ( 5.6 ) 02/2025 Dosage and Administration ( 2 ) 02/2025",
  "information_for_patients": "Hypersensitivity Inform patients that if they have experienced hypersensitivity with other GnRH agonist drugs like VABRINTY, VABRINTY is contraindicated [see Contraindications ( 4 )]. Tumor Flare Inform patients that VABRINTY can cause tumor flare during the first weeks of treatment. Inform patients that the increase in testosterone can cause an increase in urinary symptoms or pain. Advise patients to contact their healthcare provider if ureteral obstruction, spinal cord compression, paralysis, or new or worsened symptoms occur after beginning VABRINTY treatment [see Warnings and Precautions ( 5.1 )]. Hyperglycemia and Diabetes Advise patients that there is an increased risk of hyperglycemia and diabetes with VABRINTY therapy. Inform patients that periodic monitoring for hyperglycemia and diabetes is required when being treated with VABRINTY [see Warnings and Precautions ( 5.2 )]. Cardiovascular Disease Inform patients that there is an increased risk of myocardial infarction, sudden cardiac death, and stroke with VABRINTY treatment. Advise patients to immediately report signs and symptoms associated with these events to their healthcare provider for evaluation [see Warnings and Pre...",
  "spl_medguide": "",
  "clinical_studies": "One open-label, multicenter study was conducted with each VABRINTY formulation (7.5 mg, 22.5 mg, 30 mg, and 45 mg) in patients with Jewett stage A though D prostate cancer who were treated with at least a single injection of study drug (Table 7). The efficacy outcome measure was medical castration rate, defined as achieving and maintaining serum testosterone suppression to \u2264 50 ng/dL (Figures 1-4). During the AGL9904 study using VABRINTY 7.5 mg, once testosterone suppression below 50 ng/dL was achieved, no patients (0%) demonstrated breakthrough (concentration > 50 ng/dL) at any time in the study. During the AGL9909 study using VABRINTY 22.5 mg, once testosterone suppression below 50 ng/dL was achieved, one patient (< 1%) demonstrated breakthrough following the initial injection; that patient remained below 50 ng/dL following the second injection. During the AGL0001 study using VABRINTY 30 mg, once testosterone suppression below 50 ng/dL was achieved, three patients (3%) demonstrated breakthrough. In the first of these patients, a single serum testosterone concentration of 53 ng/dL was reported on the day after the second injection. In this patient, suppression below 50 ng/dL was r...",
  "brand_name": "Vabrinty",
  "manufacturer": "URONOVA PHARMACEUTICALS, INC.",
  "application_number": "NDA021379",
  "pharm_class_epc": [],
  "route": [
   "SUBCUTANEOUS"
  ],
  "effective_time": "20260430",
  "set_id": "008776cc-83f1-4f8c-819b-6471425da15f",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 86973,
  "serious": 45479,
  "death": 14228,
  "hospitalization": 15194,
  "primary_suspect": 86922,
  "top_reactions": [
   [
    "Death",
    10162
   ],
   [
    "Hot Flush",
    9911
   ],
   [
    "Intercepted Product Preparation Error",
    9222
   ],
   [
    "Syringe Issue",
    7906
   ],
   [
    "Fatigue",
    6797
   ],
   [
    "Device Leakage",
    6243
   ],
   [
    "Wrong Technique In Product Usage Process",
    5512
   ],
   [
    "Injection Site Pain",
    4820
   ],
   [
    "Prostatic Specific Antigen Increased",
    3130
   ],
   [
    "Asthenia",
    3024
   ],
   [
    "Off Label Use",
    2781
   ],
   [
    "Drug Ineffective",
    2649
   ],
   [
    "Fall",
    2429
   ],
   [
    "Arthralgia",
    2288
   ],
   [
    "Pain",
    2230
   ]
  ],
  "by_year": {
   "2019": 5892,
   "2020": 7954,
   "2021": 8781,
   "2022": 9812,
   "2023": 9201,
   "2024": 10423,
   "2025": 7721,
   "2026": 2266
  },
  "by_year_primary": {
   "2019": 5892,
   "2020": 7952,
   "2021": 8776,
   "2022": 9809,
   "2023": 9201,
   "2024": 10409,
   "2025": 7702,
   "2026": 2263
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class III",
   "date": "20230912",
   "reason": "Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.",
   "firm": "Tolmar, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20140310",
   "reason": "Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.",
   "firm": "AbbVie Inc",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20140310",
   "reason": "Defective Delivery System: Some Lupron Depot Kits may containin a syringe with a potentially defective LuproLoc needle stick protection device.",
   "firm": "AbbVie Inc",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20140310",
   "reason": "Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.",
   "firm": "AbbVie Inc",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20140310",
   "reason": "Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.",
   "firm": "AbbVie Inc",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20140310",
   "reason": "Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.",
   "firm": "AbbVie Inc",
   "status": "Terminated"
  }
 ],
 "recall_total": 6,
 "drugsfda": {
  "applications": 27,
  "nda": 17,
  "anda": 10,
  "first_approval": "19850409",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 202,
  "labeling_recent": 58,
  "sponsors": [
   "ABBVIE ENDOCRINE INC",
   "ACCORD",
   "AMNEAL",
   "EUGIA PHARMA",
   "GENZYME",
   "INVAGEN PHARMS",
   "MEITHEAL",
   "ORTHO MCNEIL JANSSEN"
  ],
  "unapproved": false,
  "first_approval_fmt": "04/09/1985"
 },
 "trials": {
  "total": 521,
  "completed": 257,
  "terminated": 75,
  "with_results": 173,
  "industry": 227,
  "phase3": 124,
  "results_share": 0.6731517509727627,
  "terminated_share": 0.14395393474088292
 },
 "pubmed": {
  "rct": 160,
  "meta": 1,
  "recent_rct": 14,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 413294.99,
  "records": 10176,
  "by_name": [
   [
    "Camcevi",
    177828.9
   ],
   [
    "Eligard",
    176332.12
   ],
   [
    "Fensolvi",
    59133.97
   ]
  ],
  "names_checked": [
   "leuprolide",
   "Eligard",
   "Camcevi",
   "Fensolvi",
   "Lupron",
   "Lutrate",
   "Vabrinty"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 41112,
  "beneficiaries": 15627,
  "spend": 176947467.03,
  "by_brand": [
   {
    "brand": "Lupron Depot",
    "claims": 31645,
    "per_claim": 5182.413861,
    "is_generic": false
   },
   {
    "brand": "Eligard",
    "claims": 9193,
    "per_claim": 1327.8041347,
    "is_generic": false
   },
   {
    "brand": "Leuprolide Depot",
    "claims": 160,
    "per_claim": 1279.3535,
    "is_generic": false
   },
   {
    "brand": "Lupron Depot-Ped",
    "claims": 99,
    "per_claim": 5299.6234343,
    "is_generic": false
   },
   {
    "brand": "Leuprolide Acetate",
    "claims": 15,
    "per_claim": 941.18066667,
    "is_generic": true
   }
  ],
  "per_claim": 4304.03451619965
 },
 "mdl": [],
 "dsc": [],
 "settlements": [
  {
   "year": 2001,
   "company": "TAP Pharmaceutical Products",
   "amount_usd": 875000000.0,
   "amount_text": "$875 million",
   "violations": "Medicare fraud, kickbacks",
   "products": "Lupron",
   "laws": "False Claims Act, Prescription Drug Marketing Act",
   "urls": [
    "https://www.justice.gov/opa/pr/2001/October/513civ.htm"
   ],
   "matched": "lupron"
  }
 ],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 96,
   "letter": "A",
   "why": [
    "Death appears in 1.8x the share of reports seen across all of FAERS (-4)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 49,
   "letter": "F",
   "why": [
    "160 randomized trials and 1 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 87,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 0 Class II, 1 Class III across 10 generic makers (-0)",
    "58 label changes approved since 2021: the safety story is still moving (-8)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 70,
   "letter": "C",
   "why": [
    "Maker paid $875 million in 2001 to settle federal allegations naming this drug (Medicare fraud, kickbacks) (-15)",
    "Pharma paid doctors $413,295 tied to this drug last year (-15)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (10 applications)",
    "4 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 79,
 "grade": "B",
 "questions": [
  "The maker paid $875 million in 2001 to settle federal allegations about how this drug was marketed. Is my use one of the uses that was promoted improperly?",
  "The most-reported problems in FDA's adverse event data are death, hot flush, intercepted product preparation error, syringe issue. How would we recognize and handle those?",
  "Why this one over buserelin, goserelin, histrelin? What would make you pick one of those instead?",
  "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.)"
 ]
}