Prescription medicine
Pegloticase Brand names: Krystexxa
Pegloticase (Krystexxa) is a prescription medicine with an FDA approval on record since 2010. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the pegloticase FDA label on DailyMed (effective July 9, 2026, Horizon Therapeutics USA, Inc.); the BLA 125293 record on Drugs@FDA; every pegloticase label on DailyMed.
Highlights of the record
FDA label of July 9, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
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 REACTIONS, G6PD DEFICIENCY ASSOCIATED HEMOLYSIS and METHEMOGLOBINEMIA See full prescribing information for complete boxed warning. […]
Used for
From the label: indications and usageKRYSTEXXA ® (pegloticase) is indicated, for the treatment of chronic gout in adult patients refractory to conventional therapy.
Forms and strengths
- 8 mg/ml
- 8 mg/50ml
Injection (solution).
On the market
- Earliest approval on file
- September 14, 2010 Krystexxa, Horizon Pharma; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 3,686 through July 30, 2026
What is pegloticase used for?
From the label: indications and usageKRYSTEXXA ® (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 ® (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. […]
Conditions named in the indications of pegloticase's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Uric Acid-specific Enzyme.
Source: FDA drug label (Krystexxa), Horizon Therapeutics USA, Inc., effective July 9, 2026 (SPL set 6e566303-d93a-4130-b764-25749829aa95), via openFDA; the full label on DailyMed
What does the patient leaflet for pegloticase say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: 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 trouble breathing dizziness, fainting, fast or weak heartbeat or feeling nervous reddening of the face, itching, hives, or feeling warm swelling of the throat or tongue, throat tightness, hoarse voice or trouble swallowing
Source: FDA drug label (Krystexxa), Horizon Therapeutics USA, Inc., effective July 9, 2026 (SPL set 6e566303-d93a-4130-b764-25749829aa95), via openFDA; the full label on DailyMed
Is there a generic for pegloticase (Krystexxa)?
No generic pegloticase is approved (Drugs@FDA, October 8, 2026).
- 2010 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the pegloticase label say about other medicines?
The pegloticase label names 3 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name pegloticase. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acetaminophen | warnings and precautions | Cases occurred in patients being pre-treated with one or more doses of an oral antihistamine, an intravenous corticosteroid and/or acetaminophen. |
| Colchicine | warnings and precautions | Gout flare prophylaxis with a non-steroidal anti-inflammatory drug (NSAID) or colchicine is recommended starting at least 1 week before initiation of KRYSTEXXA therapy and lasting at least 6 months, unless medically contraindicated or not tolerated. |
| Methotrexate | drug interactions | Co-administration of methotrexate with KRYSTEXXA may increase pegloticase concentration compared to KRYSTEXXA alone [see Clinical Pharmacology (12.3) ]. |
Other labels that name pegloticase
Source: FDA drug label (Krystexxa), Horizon Therapeutics USA, Inc., effective July 9, 2026 (SPL set 6e566303-d93a-4130-b764-25749829aa95), via openFDA; the full label on DailyMed
What do FAERS reports show for pegloticase?
The FDA Adverse Event Reporting System holds 3,686 reports that list pegloticase among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 123 are coded as a death and 751 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Pegloticase side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other