Meds & supplements › Pegloticase
Medicine · Uric Acid-specific Enzyme
Pegloticase
KRYSTEXXA ® (pegloticase) is indicated, for the treatment of chronic gout in adult patients refractory to conventional therapy.
Selected manufacturer label information, organised into consistent sections by Sofidex. Read the full label at DailyMed ↗
Boxed warning
WARNING: 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. Anaphylaxis may occur with any infusion, and generally manifests within 2 hours of the infusion. However, delayed hypersensitivity reactions have also been reported. KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions. Premedicate with antihistamines and corticosteroids and closely monitor for anaphylaxis for an appropriate period of time after administration of KRYSTEXXA. 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. 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. WARNING: ANAPHYLAXIS and INFUSION REACTIONS, G6PD DEFICIENCY ASSOCIATED HEMOLYSIS and METHEMOGLOBINEMIA See full prescribing information for complete boxed warning. Anaphylaxis and infusion reactions have been reported to occur during and after administration of KRYSTEXXA. Anaphylaxis may occur with any infusion, including a first infusion, and generally manifest within 2 hours of the infusion.
Drug facts
- Used for
- 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.
What it is used for
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 What is KRYSTEXXA?
KRYSTEXXA is a prescription medicine used in adults to help reduce the signs and symptoms of gout that are not controlled by other treatments. People with gout have too much uric acid in their bodies. Uric acid crystals collect in joints, kidneys, and other organs. This may cause pain, redness and swelling (inflammation).
KRYSTEXXA works to lower blood levels of uric acid. KRYSTEXXA is not for use in people with too much uric acid in their bodies who do not have symptoms (asymptomatic hyperuricemia). It is not known if KRYSTEXXA is safe and effective in children under 18 years of age. Who should not receive KRYSTEXXA? Do not receive KRYSTEXXA if you: have a rare blood problem called glucose 6-phosphate dehydrogenase (G6PD) deficiency or favism.
Your doctor may test you for G6PD before you start KRYSTEXXA. have had a serious allergic reaction to KRYSTEXXA or any of its ingredients. See the end of this Medication Guide for a complete list of ingredients in KRYSTEXXA.
Side effects, and when to stop
KRYSTEXXA may cause serious side effects. The most common side effects of KRYSTEXXA when given together with methotrexate include: gout flares joint pain coronavirus disease 2019 (COVID-19) nausea fatigue The most common side effects of KRYSTEXXA include: gout flares allergic reactions (including infusion reactions). nausea bruising sore throat constipation chest pain coronavirus disease 2019 (COVID-19) vomiting Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all of the side effects of KRYSTEXXA. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436).
Who should not take it
Do not take any other uric acid lowering drug, such as allopurinol, febuxostat (Uloric) or probenecid, while receiving KRYSTEXXA. Know the medicines you take. Keep a list of your medicines and show them to your doctor and pharmacist when you get a new medicine. How will I receive KRYSTEXXA? KRYSTEXXA is recommended to be given with another prescription medicine called methotrexate.
KRYSTEXXA may also be used alone. You and your doctor will decide the treatment that is right for you. Your doctor may give you medicine before your treatment of KRYSTEXXA to help reduce your risk of getting gout flares or an allergic reaction. Take these medicines as directed by your doctor or nurse. You will receive KRYSTEXXA through a needle in your vein (intravenous infusion).
Your treatment will take about 2 hours or sometimes longer. A doctor or nurse will give you the treatment. You will receive KRYSTEXXA every 2 weeks. If you have side effects, your doctor may stop or slow the infusion and may give you medicine to help the side effects. A doctor or nurse will watch you for side effects while you receive KRYSTEXXA and for some time afterwards.
Your doctor may stop your KRYSTEXXA if your uric acid levels do not become normal and stay controlled or you have certain side effects. Your gout flares may increase in the first 3 months when you start receiving KRYSTEXXA. Do not stop receiving KRYSTEXXA even if you have a flare as the amount of flares will decrease after 3 months of treatment.
Your doctor may give you other medicines to help reduce your gout flares for the first few months after starting KRYSTEXXA.
What to say before you start
Before you receive KRYSTEXXA, tell your doctor about all of your medical conditions, including if you: ever had any heart problems or high blood pressure. are pregnant or plan to become pregnant. It is not known if KRYSTEXXA will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. are breastfeeding or plan to breastfeed.
It is not known if KRYSTEXXA passes into your breast milk. You and your doctor should decide if you will receive KRYSTEXXA or breastfeed. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Cite this page
- NLM
sofidex [Internet]. Daloreum; c2026. Pegloticase; [reviewed 2026 Aug 3; cited 2026 Nov 10]. Available from: https://sofidex.com/patients/medicines/pegloticase
- APA 7th
sofidex. (2026, August 3). Pegloticase. Daloreum. Retrieved November 10, 2026, from https://sofidex.com/patients/medicines/pegloticase
- AMA 11th
Pegloticase. sofidex. Reviewed August 3, 2026. Accessed November 10, 2026. https://sofidex.com/patients/medicines/pegloticase
The cited date is today’s, because a citation records when you read the page. The reviewed date is when a clinician last checked it.