Drug/Small Molecule:
pegloticase

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PharmGKB gathers information regarding PGx on FDA drug labels from the FDA's "Table of Pharmacogenomic Biomarkers in Drug Labels", and from FDA-approved FDA and EMA-approved (European Medicines Agency) EMA labels brought to our attention. Excerpts from the label and downloadable highlighted label PDFs are manually curated by PharmGKB.

Please note that some drugs may have been removed from or added to the FDA's "Table of Pharmacogenomic Biomarkers in Drug Labels" without our knowledge. We periodically check the table for additions to this table and update PharmGKB accordingly.

There is currently no such list for European drug labels - we are working with the EMA to establish a list of European Public Assessment Reports (EPAR)s that contain PGx information. We are constructing this list by initially searching for drugs for which we have PGx-containing FDA drug labels - of these 44 EMA EPARs were identified and are being curated for pgx information.

We welcome any information regarding drug labels containing PGx information approved by the FDA, EMA or other Medicine Agencies around the world - please contact feedback.



last updated 12/18/2013

FDA Label for pegloticase and G6PD

This label is on the FDA Biomarker List
Actionable PGx

Summary

Pegloticase is used to treat chronic gout. Patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency who are treated with pegloticase are at risk of hemolysis and methemoglobinemia. Pegloticase is contraindicated for such patients.

Annotation

Patients deficient in G6PD have reduced ability to reduce the hydrogen peroxide formed as a major byproduct of the pegloticase-catalyzed oxidation of uric acid to allantoin. Excerpt from the pegloticase (KRYSTEXXA) drug label:

Before starting KRYSTEXXA, patients at higher risk for G6PD deficiency (e.g., those of African and Mediterranean ancestry) should be screened due to the risk of hemolysis and methemoglobinemia.

For the complete drug label text with sections containing pharmacogenetic information highlighted, see the pegloticase drug label.

*Disclaimer: The contents of this page have not been endorsed by the FDA and are the sole responsibility of PharmGKB.

Full label available at DailyMed

Genes and/or phenotypes found in this label

  • Gout
    • Indications & usage section
    • source: FDA Label
  • G6PD
    • Contraindications section, Patient Counseling Information, toxicity
    • source: FDA Label

last updated 06/05/2014

European Medicines Agency (EMA) Label for pegloticase and G6PD

Genetic testing required

Summary

The EMA European Public Assessment Report (EPAR) for pegloticase (Krystexxa) states that screening in patients at higher risk for G6PD deficiency should be carried out prior to pegloticase treatment. It is contraindicated in these patients due to a higher risk of hemolysis and methemoglobinemia.

Annotation

Pegloticase (Krystexxa) is indicated in patients with severe debilitating chronic tophaceous gout in whom xanthine oxidase inhibitors have failed to normalize uric acid levels or when these drugs are contraindicated. Pegloticase is contraindicated in patients with G6PD deficiency whose red blood cells are more susceptible to oxidative stress. Pegloticase works by breaking down uric acid to allantoin, releasing hydrogen peroxide which can cause oxidative stress in red blood cells in patients with G6PD deficiency who therefore have an increased risk of pegloticase-induced hemolysis and methemoglobinemia.

Excerpt from the pegloticase (Krystexxa) EPAR:

Glucose-6-phosphate dehydrogenase (G6PD) deficiency and other cellular metabolic disorders known to cause haemolysis and methemoglobinemia. All patients at higher risk for G6PD deficiency (e.g., patients of African or Mediterranean ancestry) should be screened for G6PD deficiency before starting KRYSTEXXA.

For the complete drug label text with sections containing pharmacogenetic information highlighted, see the drug name EMA drug label.

*Disclaimer: The contents of this page have not been endorsed by the EMA and are the sole responsibility of PharmGKB.

Genes and/or phenotypes found in this label

  • Gout
    • Indications & usage section, Information for patients section, Adverse reactions section, Pharmacodynamics section, Warnings and precautions section, efficacy, toxicity
    • source: European Medicines Agency (EMA) Label
  • G6PD
    • Contraindications section, Information for patients section, toxicity
    • source: European Medicines Agency (EMA) Label

PharmGKB contains no Clinical Variants that meet the highest level of criteria.

Disclaimer: The PharmGKB's clinical annotations reflect expert consensus based on clinical evidence and peer-reviewed literature available at the time they are written and are intended only to assist clinicians in decision-making and to identify questions for further research. New evidence may have emerged since the time an annotation was submitted to the PharmGKB. The annotations are limited in scope and are not applicable to interventions or diseases that are not specifically identified.

The annotations do not account for individual variations among patients, and cannot be considered inclusive of all proper methods of care or exclusive of other treatments. It remains the responsibility of the health-care provider to determine the best course of treatment for a patient. Adherence to any guideline is voluntary, with the ultimate determination regarding its application to be made solely by the clinician and the patient. PharmGKB assumes no responsibility for any injury or damage to persons or property arising out of or related to any use of the PharmGKB clinical annotations, or for any errors or omissions.

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This is a non-comprehensive list of genetic tests with pharmacogenetics relevance, typically submitted by the manufacturer and manually curated by PharmGKB. The information listed is provided for educational purposes only and does not constitute an endorsement of any listed test or manufacturer.

A more complete listing of genetic tests is found at the Genetic Testing Registry (GTR).

PGx Test Variants Assayed Gene?

Overview

Generic Names
  • 885051-90-1
  • D09316
Trade Names
  • Krystexxa
Brand Mixture Names

PharmGKB Accession Id:
PA165963961

Other Vocabularies

PharmGKB Curated Pathways

Pathways created internally by PharmGKB based primarily on literature evidence.

  1. Uric Acid-Lowering Drugs Pathway, Pharmacodynamics
    A stylized diagram showing the drugs that act to prevent uric acid formation or enhance its excretion, and adverse reactions associated with these drugs.

External Pathways

Links to non-PharmGKB pathways.

PharmGKB contains no links to external pathways for this drug. To report a pathway, click here.

Genes that are associated with this drug in PharmGKB's database based on (1) variant annotations, (2) literature review, (3) pathways or (4) information automatically retrieved from DrugBank, depending on the "evidence" and "source" listed below.

Curated Information ?

EvidenceGene
No Dosing Guideline available DL No Clinical Annotation available No Variant Annotation available No VIP available No VIP available
G6PD
No related drugs are available.

Curated Information ?

EvidenceDisease
No Dosing Guideline available DL No Clinical Annotation available No Variant Annotation available No VIP available No VIP available
Gout

Publications related to pegloticase: 1

No Dosing Guideline available No Drug Label available No Clinical Annotation available No Variant Annotation available No VIP available No VIP available
PharmGKB summary: uric acid-lowering drugs pathway, pharmacodynamics. Pharmacogenetics and genomics. 2014. McDonagh Ellen M, et al. PubMed

Clinical Trials

These are trials that mention pegloticase and are related to either pharmacogenetics or pharmacogenomics.

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Sources for PharmGKB drug information: DrugBank, Open Eye Scientific Software.