{
 "query": "pegloticase",
 "ingredient": "pegloticase",
 "slug": "pegloticase",
 "rxcui": "1011650",
 "brands": [
  "Krystexxa"
 ],
 "names": [
  "pegloticase"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "INTRAVENOUS",
  "route_counts": {
   "INTRAVENOUS": 1
  },
  "boxed_warning": "WARNING: ANAPHYLAXIS and INFUSION REACTIONS, G6PD DEFICIENCY ASSOCIATED HEMOLYSIS and METHEMOGLOBINEMIA Anaphylaxis and infusion reactions have been reported to occur during and after administration of KRYSTEXXA. ( 5.1 , 5.2 ) Anaphylaxis may occur with any infusion, and generally manifests within 2 hours of the infusion. However, delayed hypersensitivity reactions have also been reported. ( 5.1 ) KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions. ( 5.1 , 5.2 ) Premedicate with antihistamines and corticosteroids and closely monitor for anaphylaxis for an appropriate period of time after administration of KRYSTEXXA. ( 5.1 , 5.2 ) Monitor serum uric acid levels prior to each infusion and discontinue treatment if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed. ( 5.2 ) Screen patients at risk for G6PD deficiency prior to starting KRYSTEXXA. Hemolysis and methemoglobinemia have been reported with KRYSTEXXA in patients with G6PD deficiency. KRYSTEXXA is contraindicated in patients with G6PD deficiency. ( 4 , 5.3 ) WARNING: ANAPHYLAXIS and INFUSION R...",
  "indications_and_usage": "\u00ae (pegloticase) is indicated, for the treatment of chronic gout in adult patients refractory to conventional therapy. Gout refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated. KRYSTEXXA \u00ae (pegloticase) is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy. ( 1 ) Limitations of Use: KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia. ( 1 ) Limitations of Use: KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.",
  "contraindications": "is contraindicated in: Patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency [see Warnings and Precautions (5.3) ]. Patients with history of serious hypersensitivity reactions, including anaphylaxis, to KRYSTEXXA or any of its components. Patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency. ( 4 ) Patients with history of serious hypersensitivity reactions, including anaphylaxis, to KRYSTEXXA or any of its components. ( 4 )",
  "warnings_and_cautions": "Anaphylaxis : Anaphylaxis may occur with any KRYSTEXXA infusion. Pre-medicate and monitor patients. ( 5.1 ) Infusion Reactions : Infusion reactions occurred in patients treated with KRYSTEXXA. Pre-medicate and monitor patients. ( 5.2 ) G6PD Deficiency Associated Hemolysis and Methemoglobinemia : Screen patients at risk for G6PD deficiency. Do not administer KRYSTEXXA to patients with G6PD deficiency. ( 5.3 ) Gout Flares : Gout flare prophylaxis is recommended for at least the first 6 months of KRYSTEXXA therapy. ( 5.4 ) Congestive Heart Failure : Congestive heart failure exacerbation may occur. Monitor patients closely following infusion. ( 5.5 ) 5.1 Anaphylaxis In a 52-week controlled trial, which evaluated KRYSTEXXA co-administered with methotrexate compared to KRYSTEXXA alone, subjects were pre-treated with standardized infusion reaction prophylaxis and were discontinued from treatment with KRYSTEXXA if serum uric acid levels increased to above 6 mg/dL at 2 consecutive visits after the initiation of KRYSTEXXA therapy to reduce the risk of anaphylaxis. One subject randomized to the group treated with KRYSTEXXA co-administered with methotrexate (1%) experienced anaphylaxis during ...",
  "warnings": "",
  "adverse_reactions": "The following serious adverse reactions are discussed in greater detail in other sections of the label: Anaphylaxis [see Warnings and Precautions (5.1) ] Infusion Reactions [see Warnings and Precautions (5.2) ] G6PD Deficiency Associated Hemolysis and Methemoglobinemia [see Warnings and Precautions (5.3) ] Gout Flares [see Warnings and Precautions (5.4) ] Congestive Heart Failure [see Warnings and Precautions (5.5) ] Co-administration with methotrexate: The most common adverse reactions (\u2265 5% of patients) are gout flares, arthralgia, COVID-19, nausea and fatigue. ( 6.1 ) KRYSTEXXA alone: The most common adverse reactions (\u2265 5% of patients) are gout flares, infusion reactions, nausea, contusion or ecchymosis, nasopharyngitis, constipation, chest pain, anaphylaxis and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying and controlled conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug, and...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Dosage and Administration ( 2.1 , 2.3 ) 8/2025",
  "information_for_patients": "Advise patients to read the FDA-approved patient labeling (Medication Guide). Anaphylaxis and Infusion Reactions Anaphylaxis and infusion reactions can occur at any infusion while on therapy. Counsel patients on the importance of adhering to any prescribed medications, to help prevent or lessen the severity of these reactions. Educate patients on the signs and symptoms of anaphylaxis, including wheezing, peri-oral or lingual edema, hemodynamic instability, and rash or urticaria, nausea or vomiting. Educate patients on the most common signs and symptoms of an infusion reaction, including urticaria (skin rash), erythema (redness of the skin), dyspnea (difficulty breathing), flushing, chest discomfort, chest pain, and rash. Advise patients to seek medical care immediately if they experience any symptoms of an allergic reaction during or at any time after the infusion of KRYSTEXXA [see Warnings and Precautions (5.1 , 5.2) , Adverse Reactions (6.1) ] . Advise patients to discontinue any oral urate-lowering agents before starting on KRYSTEXXA and not to take any oral urate-lowering agents while on KRYSTEXXA. Glucose-6-phosphate dehydrogenase (G6PD) Deficiency Inform patients not to take ...",
  "spl_medguide": "This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 06/2026 Medication Guide KRYSTEXXA \u00ae (kris-TEX-a) (pegloticase) injection, for intravenous use Read this Medication Guide before you start receiving KRYSTEXXA and before each treatment. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. Talk to your doctor if you have any questions about your treatment with KRYSTEXXA. What is the most important information I should know about KRYSTEXXA? Serious allergic reactions may happen in some people who receive KRYSTEXXA. These allergic reactions can be life threatening and usually happen within 2 hours of the infusion. KRYSTEXXA should be given to you by a doctor or nurse in a healthcare setting where serious allergic reactions can be treated. Your doctor or nurse should watch you for any signs of a serious allergic reaction during and after your treatment with KRYSTEXXA. Tell your doctor or nurse right away if you have any of these symptoms during or after your treatment with KRYSTEXXA: wheezing, shortness of breath, cough, chest tightness, chest pain, or t...",
  "clinical_studies": "Co-administration with Methotrexate A 52-week, randomized, double-blind trial was conducted in adult subjects with chronic gout refractory to conventional therapy, to evaluate administration of KRYSTEXXA 8 mg every 2 weeks co-administered with weekly administration of methotrexate 15 mg, compared to KRYSTEXXA alone: Trial 1 (NCT03994731). In this trial, patients were na\u00efve to KRYSTEXXA therapy. Subjects who were able to tolerate two weeks on oral methotrexate 15 mg were then randomized to receive four additional weeks on either methotrexate 15 mg or matching placebo prior to initiating KRYSTEXXA therapy in a 2:1 ratio. Subjects were pre-treated with a standardized infusion reaction prophylaxis regimen consisting of an oral fexofenadine, acetaminophen and intravenous methylprednisolone prior to each KRYSTEXXA infusion. Methotrexate or placebo was continued weekly throughout the KRYSTEXXA treatment period with daily oral folic acid in order to evaluate the immunomodulatory effect of methotrexate to attenuate development of anti-drug antibodies. Entry criteria for subjects to be eligible for this trial were: baseline serum uric acid \u2265 7 mg/dL and inability to maintain serum uric acid ...",
  "brand_name": "Krystexxa",
  "manufacturer": "Horizon Therapeutics USA, Inc.",
  "application_number": "BLA125293",
  "pharm_class_epc": [
   "Uric Acid-specific Enzyme [EPC]"
  ],
  "route": [
   "INTRAVENOUS"
  ],
  "effective_time": "20260709",
  "set_id": "6e566303-d93a-4130-b764-25749829aa95",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 3454,
  "serious": 1591,
  "death": 112,
  "hospitalization": 688,
  "primary_suspect": 3454,
  "top_reactions": [
   [
    "Gout",
    521
   ],
   [
    "Blood Uric Acid Increased",
    401
   ],
   [
    "Infusion Related Reaction",
    297
   ],
   [
    "Therapeutic Response Decreased",
    186
   ],
   [
    "Dyspnoea",
    172
   ],
   [
    "Drug Ineffective",
    144
   ],
   [
    "Nausea",
    142
   ],
   [
    "Urticaria",
    142
   ],
   [
    "Pruritus",
    127
   ],
   [
    "Rash",
    126
   ],
   [
    "Off Label Use",
    124
   ],
   [
    "Chest Pain",
    110
   ],
   [
    "Dizziness",
    108
   ],
   [
    "Pain",
    104
   ],
   [
    "Fatigue",
    100
   ]
  ],
  "by_year": {
   "2019": 384,
   "2020": 240,
   "2021": 101,
   "2022": 351,
   "2023": 426,
   "2024": 582,
   "2025": 473,
   "2026": 332
  },
  "by_year_primary": {
   "2019": 384,
   "2020": 240,
   "2021": 101,
   "2022": 351,
   "2023": 426,
   "2024": 582,
   "2025": 473,
   "2026": 332
  }
 },
 "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": "20100914",
  "rems": false,
  "rems_last": "20160411",
  "labeling_supplements": 0,
  "labeling_recent": 0,
  "sponsors": [
   "HORIZON PHARMA"
  ],
  "unapproved": false,
  "first_approval_fmt": "09/14/2010"
 },
 "trials": {
  "total": 23,
  "completed": 21,
  "terminated": 0,
  "with_results": 15,
  "industry": 19,
  "phase3": 4,
  "results_share": 0.7142857142857143,
  "terminated_share": 0.0
 },
 "pubmed": {
  "rct": 16,
  "meta": 2,
  "recent_rct": 6,
  "cochrane": [
   {
    "pmid": "20238366",
    "title": "Pegloticase for chronic gout",
    "year": "2010"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 5301725.12,
  "records": 41520,
  "by_name": [
   [
    "Krystexxa",
    5301725.12
   ]
  ],
  "names_checked": [
   "pegloticase",
   "Krystexxa"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 4801,
  "beneficiaries": 662,
  "spend": 212349149.7,
  "by_brand": [
   {
    "brand": "Krystexxa",
    "claims": 4801,
    "per_claim": 44230.191564,
    "is_generic": false
   }
  ],
  "per_claim": 44230.191564257446
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 70,
   "letter": "C",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "Death share in reports is near or below the FAERS average (0.4x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 39,
   "letter": "F",
   "why": [
    "16 randomized trials and 2 systematic reviews/meta-analyses indexed in PubMed",
    "1 independent Cochrane review(s) exist"
   ],
   "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": 70,
   "letter": "C",
   "why": [
    "Pharma paid doctors $5,301,725 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": 63,
 "grade": "C",
 "questions": [
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "The most-reported problems in FDA's adverse event data are gout, blood uric acid increased, infusion related reaction, therapeutic response decreased. 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.)"
 ]
}