Drug
pegloticase

PharmGKB contains no dosing guidelines for this . To report known genotype-based dosing guidelines, or if you are interested in developing guidelines, click here.

PharmGKB annotates drug labels containing pharmacogenetic information approved by the US Food and Drug Administration (FDA), European Medicines Agency (EMA), the Pharmaceuticals and Medical Devices Agency, Japan (PMDA), and Health Canada (Santé Canada) (HCSC). PharmGKB annotations provide a brief summary of the PGx in the label, an excerpt from the label and a downloadable highlighted label PDF file. A list of genes and phenotypes found within the label is mapped to label section headers and listed at the end of each annotation. PharmGKB also attempts to interpret the level of action implied in each label with the "PGx Level" tag.

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last updated 12/18/2013

FDA Label for pegloticase and G6PD

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.

To see more Clinical Variants with lower levels of criteria, click the button at the bottom of the page.

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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The table below contains information about pharmacogenomic variants on PharmGKB. Please follow the link in the "Variant" column for more information about a particular variant. Each link in the "Variant" column leads to the corresponding PharmGKB Variant Page. The Variant Page contains summary data, including PharmGKB manually curated information about variant-drug pairs based on individual PubMed publications. The PMIDs for these PubMed publications can be found on the Variant Page.

The tags in the first column of the table indicate what type of information can be found on the corresponding Variant Page.

Links in the "Gene" column lead to PharmGKB Gene Pages.

List of all variant annotations for pegloticase

Gene ? Variant?
(144)
Alternate Names ? Drugs ? Alleles ?
(+ chr strand)
Function ? Amino Acid?
Translation
No VIP available CA VA G6PD A- 202A_376G N/A N/A N/A
Alleles, Functions, and Amino Acid Translations are all sourced from dbSNP 144

Overview

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

PharmGKB Accession Id:
PA165963961
Type(s):
Drug

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 CA VA No VIP available No VIP available
G6PD
No related drugs are available.

Curated Information ?

Publications related to pegloticase: 2

No Dosing Guideline available No Drug Label available CA VA No VIP available No VIP available
Methaemoglobinaemia and haemolysis following pegloticase infusion for refractory gout in a patient with a falsely negative glucose-6-phosphate dehydrogenase deficiency result. Rheumatology (Oxford, England). 2014. Geraldino-Pardilla Laura, et al. PubMed
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.

No trials found.

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