Substance / Medication

Pegloticase

Overview

Active Ingredient
pegloticase
RxNorm CUI
1011650

Indications

® KRYSTEXXA(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.

Labeler: Horizon Therapeutics USA, Inc.Updated: 2025-08-29T00:00:00.000ZFull label on DailyMed

Boxed Warning

FDA Black Box Warning

5.1 5.2 Anaphylaxis and infusion reactions have been reported to occur during and after administration of KRYSTEXXA. (,) 5.1 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 5.

Contraindications

When this intervention should not be used

KRYSTEXXA is contraindicated in: Warnings and Precautions (5.3) [see]. Patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency Patients with history of serious hypersensitivity reactions, including anaphylaxis, to KRYSTEXXA or any of its components.

Indications & Related Conditions

Conditions associated via SNOMED clinical relationships

Administration & Protocol

Dosing, route, and treatment protocol

Detailed dosage and administration information is available in the full FDA drug label.

View full prescribing information on DailyMed

Monitoring & Follow-Up

Biomarkers relevant to this intervention via related conditions

No monitoring biomarkers have been mapped yet. Biomarker-intervention linkages are derived through related conditions and will expand as the knowledge graph grows.

Clinical Trials

25 trials linked to this intervention

25
Total Trials
7
Recruiting
13
With Results

Research Evidence

Published studies and systematic reviews

Sort:
The effect of immunomodulators on the efficacy and tolerability of pegloticase: a systematic review.
Keenan Robert T, Botson John K, Masri Karim R et al. · Semin Arthritis Rheum · 2021
PMID: 33601190Meta-Analysis
Pegloticase for chronic gout.
Anderson Amy, Singh Jasvinder A · Cochrane Database Syst Rev · 2010
PMID: 20238366Meta-AnalysisFull text (PMC)
Dissociation Between Clinical Benefit and Persistent Urate Lowering in Patients with Chronic Refractory Gout Treated with Pegloticase.
Pillinger Michael H, Fields Theodore R, Yeo Anthony E et al. · J Rheumatol · 2020
PMID: 31203212RCT
Pegloticase immunogenicity: the relationship between efficacy and antibody development in patients treated for refractory chronic gout.
Lipsky Peter E, Calabrese Leonard H, Kavanaugh Arthur et al. · Arthritis Res Ther · 2014
PMID: 24588936RCTFull text (PMC)
Pegloticase in Combination With Methotrexate in Patients With Uncontrolled Gout: A Multicenter, Open-label Study (MIRROR).
Botson John K, Tesser John R P, Bennett Ralph et al. · J Rheumatol · 2021
PMID: 32934137Observational
Frequency, distribution and immunologic nature of infusion reactions in subjects receiving pegloticase for chronic refractory gout.
Calabrese Leonard H, Kavanaugh Arthur, Yeo Anthony E et al. · Arthritis Res Ther · 2017
PMID: 28818095ObservationalFull text (PMC)

Research data from MEDLINE/PubMed

Benefits & Expected Outcomes

Benefits, expected outcomes, efficacy data, and NNT (Number Needed to Treat) are pending physician authorship and evidence review.

Risks & Side Effects

Adverse reaction and safety data for this drug is sourced from the FDA-approved label.

View adverse reactions & drug interactions on DailyMed

Related Symptoms

Symptoms associated with conditions this intervention addresses

No related symptoms have been mapped yet. Symptom linkages are derived through associated conditions.

Alternatives & Comparisons

Alternative treatments, comparison data, and clinical decision support are pending physician authorship.

Medical Disclaimer

This information is for educational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult with a qualified healthcare provider regarding any medical condition or treatment plan.

Do not start, stop, or change any treatment without consulting your healthcare provider.

Quick Facts

Type
Substance / Medication
Fully Specified Name
Pegloticase (substance)
SNOMED CT
449280003
UMLS CUI
C2350656
RxNorm CUI
1011650
Labeler
Horizon Therapeutics USA, Inc.

Clinical Data

This intervention maps to 1 entities in the Healos knowledge graph.

1
Conditions
0
Biomarkers
0
Specialists
0
Symptoms
25
Clinical Trials

Data is sourced from SNOMED CT, UMLS, and the Healos clinical knowledge graph. Content sections marked as pending require physician authorship. Consult a healthcare provider before starting any treatment.