TM Owner Horizon Therapeutics
Krystexxa 8 mg/mL Vial (Solution for Injection)
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Indications & Clinical Uses
- Krystexxa 8 mg/mL is pegloticase, a PEGylated recombinant uricase (urate oxidase) enzyme that converts uric acid into allantoin, which the kidneys excrete easily.
- It is approved for the treatment of chronic gout in adult patients refractory to conventional therapy - gout that has not responded to maximally titrated urate-lowering medicines such as allopurinol or febuxostat.
- It is not recommended for asymptomatic hyperuricaemia.
- Krystexxa is given only in a healthcare setting, as an intravenous infusion over a minimum of 120 minutes, once every 2 weeks; it is never given as an intravenous push or bolus and is never self-injected.
- For most patients the label directs co-administration of weekly oral methotrexate 15 mg with folic or folinic acid supplementation, started at least 4 weeks before the first infusion, to reduce anti-drug antibody formation and improve the sustained response rate.
- The US label holder is Horizon Therapeutics USA.
Side Effects
- Krystexxa carries a BOXED WARNING for ANAPHYLAXIS AND INFUSION REACTIONS, which have occurred during and after infusions and typically appear within 2 hours.
- It must be given in a healthcare setting equipped to manage anaphylaxis, after premedication with antihistamines and corticosteroids, with close monitoring.
- The boxed warning also requires SCREENING FOR G6PD DEFICIENCY before treatment, because pegloticase can cause life-threatening haemolysis and methaemoglobinaemia in G6PD-deficient patients, and it directs that treatment stop if serum uric acid rises above 6 mg/dL on two consecutive occasions, since that predicts reaction risk.
- Gout flares are the commonest reaction, in 67% of patients taking methotrexate alongside and 77% on Krystexxa alone.
- Other common effects are joint pain (14%), nausea, fatigue, bruising and constipation.
- Get urgent help for wheeze, throat tightness, rash, dizziness, chest pain, dark urine or breathlessness.
Precautions & Warnings
- Krystexxa is contraindicated in G6PD deficiency and in anyone who has had a serious hypersensitivity reaction or anaphylaxis to pegloticase.
- Screen for G6PD deficiency before starting, particularly in people of African, Mediterranean or Southern Asian ancestry.
- Serum uric acid must be measured before each infusion, because a level above 6 mg/dL signals loss of response and a higher risk of anaphylaxis.
- It is FOR INTRAVENOUS INFUSION ONLY, over at least 120 minutes, NEVER as a bolus, and the infusion must be slowed or stopped for any reaction.
- Use caution in congestive heart failure and monitor closely after each infusion, as exacerbations have been reported.
- Gout flare prophylaxis with an NSAID or colchicine is recommended for at least the first 6 months.
- Unopened vials are kept in the carton under refrigeration at 2 C to 8 C at all times, protected from light; do not shake and do not freeze.
Avoid Interactions
- The key instruction is to STOP oral urate-lowering therapy - allopurinol, febuxostat and similar agents - before the first Krystexxa infusion and not to restart it during treatment, because these drugs mask a rising uric acid level and so hide the warning sign that predicts anaphylaxis.
- Methotrexate is deliberately co-prescribed rather than avoided: weekly oral methotrexate raises pegloticase concentrations and reduces immunogenicity, so folic or folinic acid is given with it and the usual methotrexate cautions apply, including liver and blood-count monitoring, avoiding excess alcohol, and effective contraception.
- Krystexxa must not be mixed with other medicines in the same bag or infusion line, and the diluted solution is prepared by the pharmacy or infusion team exactly as the label directs.
- Tell your care team about every prescription medicine, over-the-counter product and supplement you use, and about pregnancy, breastfeeding or plans to conceive.
References
Frequently Asked Questions
Krystexxa (pegloticase) treats chronic gout in adults whose gout has not responded to conventional urate-lowering medicines such as allopurinol or febuxostat. It is an enzyme that breaks uric acid down into allantoin, which is easily passed in urine. It is not used for symptom-free high uric acid.
Krystexxa (pegloticase) is given as an intravenous infusion every 2 weeks, over at least 120 minutes, in a healthcare setting. It is never given as a quick injection or bolus. Most patients also take weekly oral methotrexate 15 mg with folate, started at least 4 weeks beforehand.
Gout flares are the most common side effect of Krystexxa (pegloticase), affecting 67 to 77 percent of patients, especially early on. Joint pain, nausea, fatigue and bruising are also common. Infusion reactions and anaphylaxis are the serious risks, so report wheeze, throat tightness, rash or dizziness immediately.
Stop allopurinol, febuxostat and other oral urate-lowering tablets before Krystexxa (pegloticase) starts, and do not restart them during treatment, because they hide the rising uric acid level that warns of anaphylaxis. Krystexxa must not be mixed with other medicines in the same infusion line.
You must be screened for G6PD deficiency before Krystexxa, because pegloticase can cause life-threatening red blood cell breakdown and methaemoglobinaemia in G6PD-deficient people. Uric acid is checked before every infusion, and treatment stops if it rises above 6 mg/dL on two consecutive occasions.
Krystexxa carries a boxed warning for anaphylaxis and infusion reactions, which can occur during or within 2 hours of any infusion. It must be given where anaphylaxis can be treated, after antihistamine and corticosteroid premedication. The warning also requires G6PD screening, as pegloticase is contraindicated in G6PD deficiency.
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