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Recombinant Uricase — Urate-Lowering Biologic

Pegloticase (Recombinant PEGylated Uricase — Refractory Gout)

Brand names: Krystexxa

Pegloticase is a specialist intravenous recombinant PEGylated uricase used in the treatment of severe, debilitating chronic refractory gout in adults whose disease has not responded to conventional urate-lowering therapy.

Dosing — being independently re-sourced

ClinCalc Pro is rebuilding its dose data from primary open sources — the manufacturer SmPC (eMC), the WHO Model Formulary and other official references — under clinician review. This drug's structured dose is not yet published here. Confirm all doses against the product SmPC and your local formulary before prescribing.

Clinical monograph

How it works

It is a pegylated recombinant uricase enzyme that catalyses the oxidation of uric acid to allantoin, a more soluble and readily excreted compound, thereby rapidly lowering serum urate.

Prescribing in practice

  • Anaphylaxis and infusion reactions can occur, so it must be given under specialist supervision with premedication and resuscitation facilities, and discontinued if serum urate rises persistently as this signals loss of response and increased reaction risk.
  • It is contraindicated in glucose-6-phosphate dehydrogenase (G6PD) deficiency owing to the risk of haemolysis and methaemoglobinaemia, so screen high-risk patients beforehand.
  • Gout flares are common when treatment begins, so anti-inflammatory flare prophylaxis is recommended.

Monitoring

Monitor serum urate before each infusion to detect loss of response and observe closely for infusion and hypersensitivity reactions.

Counselling the patient

  • You may experience a gout flare early in treatment; this does not mean the medicine is not working.
  • Report any rash, swelling, chest tightness or breathlessness during or after the infusion immediately.

Evidence & guidelines

Use is supported by the Summary of Product Characteristics and randomised controlled trials in chronic refractory gout.

Reference: Sundy et al. NEJM 2011 (CRYSTAL trial); Botson et al. ACR 2023 (MIRROR trial); FDA Krystexxa PI; BSR Gout Guidelines 2022; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.