Krystexxa
Pronunciation: pronunciation varies by local usage.
- Generic name
- pegloticase
- Brand names
- KRYSTEXXA
- Drug class
- PEGylated uric acid specific enzyme
- Form
- Injection for intravenous infusion
- Route
- Intravenous infusion
- Legal status
- Prescription-only medicine
Availability and supply rules vary by country
Trade names by country: United States
Australia: · Full directory
What pegloticase is and how it works
Pegloticase is a PEGylated uric acid specific enzyme (uricase). KRYSTEXXA is indicated for the treatment of chronic gout in adult patients refractory to conventional therapy. (1)
KRYSTEXXA is administered as an intravenous infusion in a healthcare setting with immediate access to personnel and equipment to manage anaphylaxis and infusion reactions. It is co-administered with weekly oral methotrexate, unless methotrexate is contraindicated. Patients must be screened for glucose-6-phosphate dehydrogenase (G6PD) deficiency before starting treatment.
Mechanism of action: how pegloticase works
Pegloticase is a PEGylated uric acid specific enzyme (uricase). (1)
What pegloticase is used for
Chronic gout refractory to conventional therapy
KRYSTEXXA is indicated for the treatment of chronic gout in adult 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. (1)
Before taking pegloticase
Do not take / not appropriate for
- Tell the treating clinician about any known or suspected glucose-6-phosphate dehydrogenase (G6PD) deficiency. The label lists this as a contraindication due to the risk of hemolysis and methemoglobinemia; the clinician must determine whether KRYSTEXXA can be given. Screening for G6PD deficiency is recommended before starting treatment, particularly in patients of African or Mediterranean descent. (all patients) (1)
Tell your clinician about
- If you have G6PD deficiency or have been told you might have it.
- All current medicines, especially allopurinol or febuxostat (the label recommends avoiding concurrent use of these urate-lowering agents).
- If you are pregnant, planning pregnancy, or breastfeeding — the label lists this as Pregnancy Category C with safety in human pregnancy not established, and breastfeeding is not recommended.
How to take pegloticase
- KRYSTEXXA is given as an intravenous infusion by a healthcare professional in a medical setting equipped to manage anaphylaxis and infusion reactions.
- The usual dose is 8 mg every two weeks. It is co-administered with weekly oral methotrexate 15 mg, unless methotrexate is contraindicated.
- You will receive premedication with antihistamines and corticosteroids before each infusion to reduce the risk and severity of infusion reactions.
- Do not attempt to self-administer this medicine or alter the dosing schedule on your own.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1)
Missed dose
If you miss a scheduled infusion appointment, contact the treating clinic for rescheduling instructions. Do not attempt to adjust the dosing schedule yourself.
Overdose
KRYSTEXXA is given as an intravenous infusion by a healthcare professional, so a self-administered overdose is not a realistic risk. No cases of overdose with KRYSTEXXA have been reported. The largest single intravenous dose that has been given is 12 mg of uricase protein. There is no specific antidote — anyone suspected of having received an overdose should be monitored and given general supportive care. (1)
Side effects
Adverse reactions can occur. Anaphylaxis and infusion reactions are serious risks that may happen during or after administration. Gout flares are common during the first three months of treatment.
Gout flares
What to notice: The reviewed label lists this as a common adverse reaction (occurring in ≥5% of patients) without further patient-facing detail.
What to do: The treating clinician decides whether KRYSTEXXA should be continued during a gout flare; the reviewed label notes that discontinuation is not required for this reason alone. Flare-prophylaxis (e.g., NSAIDs or colchicine) is recommended for at least 6 months when starting treatment. Tell the healthcare provider if flares are severe or persistent. (1)
Infusion reactions
What to notice: The reviewed label lists infusion reactions as a common adverse reaction without a specific patient-facing symptom description. Tell the healthcare staff about anything you notice during or shortly after the infusion.
What to do: Infusion reactions can be serious. Healthcare professionals will monitor you during and after the infusion. Report any symptoms immediately. (1)
Nausea
What to notice: The reviewed label lists this as a common adverse reaction (occurring in ≥5% of patients) without a specific patient-facing symptom description.
What to do: Tell the healthcare provider about this. (1)
Contusion or ecchymosis
What to notice: The reviewed label lists this as a common adverse reaction (occurring in ≥5% of patients) without a specific patient-facing symptom description.
What to do: Tell the healthcare provider about this. (1)
Nasopharyngitis
What to notice: The reviewed label lists this as a common adverse reaction (occurring in ≥5% of patients) without a specific patient-facing symptom description.
What to do: Tell the healthcare provider about this. (1)
Constipation
What to notice: The reviewed label lists this as a common adverse reaction (occurring in ≥5% of patients) without a specific patient-facing symptom description.
What to do: Tell the healthcare provider about this. (1)
Chest pain
What to notice: The reviewed label lists this as a common adverse reaction (occurring in ≥5% of patients) without further patient-facing detail.
What to do: Tell the healthcare provider about this. (1)
Anaphylaxis
What to notice: Not established from the sources reviewed: a detailed patient-facing symptom list was not established in the sources reviewed for this page beyond the reaction name itself.
What to do: Anaphylaxis is a medical emergency. Alert the healthcare team immediately; they are equipped to manage this in the infusion setting. (1)
Vomiting
What to notice: The reviewed label lists this as a common adverse reaction (occurring in ≥5% of patients) without a specific patient-facing symptom description.
What to do: Tell the healthcare provider about this. (1)
Severe infusion reaction
What to notice: Not established from the sources reviewed: a specific patient-facing symptom list was not established in the sources reviewed for this page beyond "infusion reaction" as the reaction name. Tell the healthcare staff about anything you notice during or shortly after the infusion.
What to do: Seek immediate medical attention. During an infusion, alert the healthcare staff right away. (1)
Signs of hemolysis or methemoglobinemia
What to notice: The reviewed label identifies hemolysis and methemoglobinemia as risks in patients with G6PD deficiency.
What to do: These may indicate a serious complication, particularly in patients with G6PD deficiency. Contact the treating clinician immediately. (1)
Serious warnings
Anaphylaxis and infusion reactions — emergency
Symptoms: Not established from the sources reviewed: a detailed patient-facing symptom list was not established in the sources reviewed for this page beyond "anaphylaxis and infusion reactions" as the named risks in the boxed warning.
Action: Anaphylaxis and infusion reactions have been reported to occur during and after administration. This is why KRYSTEXXA is given in a healthcare setting with immediate access to personnel and equipment for these risks. Alert the healthcare provider immediately if you feel unwell. (1)
FDA BOXED WARNING — G6PD deficiency: haemolysis and methaemoglobinaemia — emergency
Symptoms: Sudden pallor, marked tiredness or breathlessness, dark or cola-coloured urine, yellowing of the eyes or skin, or a blue-grey tinge to the lips, fingertips or skin. These can begin during or soon after an infusion.
Action: Pegloticase is contraindicated in people with G6PD deficiency. The label requires screening for G6PD deficiency before the first dose, and screening is particularly important for people of African, Mediterranean, Middle Eastern or South-East Asian ancestry, in whom G6PD deficiency is more common. If any of these signs appear, get emergency medical help immediately and tell the treating team you have received pegloticase. (1)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Oral urate-lowering agents (allopurinol, febuxostat) | The label recommends avoiding concurrent use. | The label recommends avoiding concurrent use of oral urate-lowering agents with KRYSTEXXA. Tell the prescriber about all current gout medications so they can decide how to manage this. (1) |
| Other PEGylated therapeutic products | Anti-PEG (polyethylene glycol) antibodies that can develop with pegloticase use may interact with other PEGylated therapeutic products; the clinical impact is not established in the sources reviewed for this page. | Make sure the healthcare provider is aware of all biologic or PEGylated products you have received or are receiving. (1) |
| Methotrexate | The label recommends co-administration with weekly oral methotrexate. | Take weekly oral methotrexate exactly as prescribed. If you cannot take methotrexate, your doctor will decide whether KRYSTEXXA may be given alone. (1) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
Pregnancy Category C: safety in human pregnancy has not been established. Discuss pregnancy plans with your treating clinician. (1)
Lactation
Breastfeeding is not recommended because it is not known whether pegloticase is excreted in human milk. (1)
Patients with G6PD deficiency
KRYSTEXXA is contraindicated in patients with G6PD deficiency due to the risk of hemolysis and methemoglobinemia. Screening is recommended before treatment, particularly in patients of African or Mediterranean ancestry. (1)
Pediatric use
The reviewed labeling covers adult patients. (1)
Monitoring
Before starting
- Screen for G6PD deficiency (established label recommendation).
During treatment
- Check serum uric acid levels before each infusion. The treating clinician will decide whether to discontinue treatment if levels rise above 6 mg/dL, particularly with consecutive elevated readings.
- Observe for signs and symptoms of infusion reactions and anaphylaxis during and after each infusion.
- Manage gout flare prophylaxis with NSAIDs or colchicine, typically for at least the first 6 months.
- G6PD deficiency is a contraindication.
Storage
Storage instructions are not detailed in the reviewed source. Follow the handling and storage guidelines provided by the healthcare facility or pharmacist.
Professional information
Clinician-facing context only. Use the current local prescribing information and treatment guidelines.
United States
Indication: Chronic gout refractory to conventional therapy
Dose summary: 8 mg pegloticase administered as an intravenous infusion every 2 weeks, co-administered with weekly oral methotrexate 15 mg. Patients should receive antihistamines and corticosteroids before each infusion. KRYSTEXXA may be used alone in patients for whom methotrexate is contraindicated or not clinically appropriate.
Renal context: No dose adjustment is required for renal impairment. No formal studies were conducted to examine the effect of renal impairment on pegloticase pharmacokinetics. (1)
Hepatic guidance
No formal studies were conducted to examine the effect of hepatic impairment on pegloticase pharmacokinetics, and the label specifies no hepatic dose adjustment.
Frequently asked questions
Why do I need to take methotrexate with KRYSTEXXA?
The label recommends taking weekly oral methotrexate together with KRYSTEXXA. If you cannot take methotrexate, your doctor may decide to use KRYSTEXXA alone. (1)
What should I do if I miss a scheduled infusion?
Contact your healthcare provider's office as soon as possible to reschedule. Do not try to receive extra infusions to make up for the missed dose. (1)
Can I continue my other gout medications?
The label recommends avoiding concurrent use of oral urate-lowering drugs like allopurinol and febuxostat with KRYSTEXXA; discuss your current gout medicines with the prescriber. Gout flare prophylaxis (such as NSAIDs or colchicine) is recommended for at least 6 months after starting treatment. (1)
What are the signs of an infusion reaction?
Not established from the sources reviewed: a specific patient-facing symptom list for infusion reactions was not established in the sources reviewed for this page beyond the reaction name itself. Report anything you notice during or shortly after the infusion to the healthcare staff immediately. (1)
What is the mechanism of action of pegloticase?
Pegloticase is a PEGylated uric acid specific enzyme (uricase). (1)
What is the generic name of Krystexxa?
The generic name is pegloticase. It is sold under brand names including KRYSTEXXA. (1)
What class of drug is pegloticase?
Krystexxa is classed as: PEGylated uric acid specific enzyme. (1)
References
- KRYSTEXXA (pegloticase) Injection, for intravenous infusionU.S. Food and Drug Administration (via DailyMed) · United States · dated 2010 (initial approval); current revision date not provided · accessed 2026-08-05 · source 1
- KRYSTEXXA (PEGLOTICASE) INJECTION, SOLUTION [HORIZON THERAPEUTICS USA, INC.] — US prescribing information (DailyMed SPL)U.S. National Library of Medicine (DailyMed) · US · accessed 2026-08-14 · source 2
- Pegloticase Injection — patient drug information (MedlinePlus)U.S. National Library of Medicine (MedlinePlus) · US · accessed 2026-08-14 · source 3
- Krystexxa — FDA approval record (Drugs@FDA BLA125293)U.S. Food and Drug Administration · US · accessed 2026-08-14 · source 4
- pegloticase — RxNorm normalized drug concept (RXCUI 1011650)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 5
Brand names by country
Single-ingredient pegloticase names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- Krystexxa8 mg/50mL, 8 mg/mL · horizon therapeutics usa, inc.