KRYSTEXXA
KRYSTEXXA is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients who are refractory to conventional therapy. This patient population includes individuals who have failed to normalize serum uric acid levels or achieve symptom control with maximum doses of xanthine oxidase inhibitors, as well as those for whom these standard treatments are contraindicated. The medication is not recommended for the treatment of asymptomatic hyperuricemia. It provides a therapeutic alternative for managing symptomatic gout when standard oral therapies are ineffective or inappropriate.
How KRYSTEXXA Works
KRYSTEXXA is a recombinant uricase that lowers serum uric acid by catalyzing its oxidation into allantoin. Allantoin is an inert and water-soluble purine metabolite, making it significantly easier for the body to process than uric acid. Once converted, allantoin is readily eliminated from the system, primarily through renal excretion. This enzymatic conversion directly reduces the concentration of uric acid circulating in the blood.
Details
- Status
- Prescription
- First Approved
- 2010-09-14
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
KRYSTEXXA Approval History
What KRYSTEXXA Treats
2 indicationsKRYSTEXXA is approved for 2 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Gout
- Hyperuricemia
KRYSTEXXA Boxed 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. ( 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 anaph...
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. ( 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. 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, including a first infusion, and generally manifest 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 ) Pre-medicate 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 ac
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Trial Timeline
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
KRYSTEXXA FDA Label Details
ProIndications & Usage
FDA Label (PDF)KRYSTEXXA ® (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. Limitations of Use: KRYSTE...
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. ( 5.1 , 5.2 ) Anaphylaxis may occur with any infusion, and generally manifests within 2...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.