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    DEA Class; Rx

    Common Brand Names; Krystexxa

    • Enzymes, Oncology; 
    • Rheumatologics, Other

    Recombinant urate oxidase enzyme; pegylated product; converts uric acid to allantoin, a benign metabolite
    Used in chronic gout refractory to conventional oral therapy in combination with oral methotrexate and folic acid or folinic acid supplementation or as monotherapy when methotrexate not clinically appropriate; given as IV infusion only; high cost
    Boxed warning for risk of infusion-related and hypersensitivity reactions; premedicate patients with antihistamines and corticosteroids and monitor for 1 hour after each dose

    Indicated for treatment of chronic gout in adults refractory to conventional treatment

    Pegloticase alone may be used in patients for whom methotrexate is contraindicated or not clinically appropriate

    History of serious hypersensitivity, including anaphylaxis, to pegloticase or its components

    G6PD-deficiency (increased risk of hemolysis and methemoglobinemia)

    • Gout flares (77%)
    • Infusion reactions (26%)
    • Nausea (12%)
    • Urticaria (10.6%)
    • Chest discomfort (9.5%)
    • Chest pain (9.5%)
    • Erythema (9.5%)
    • Pruritus (9.5%)
    • Nasopharyngitis (7%)
    • Anaphylaxis (5%)

    Life threatening hemolytic reactions and methemoglobinemia reported with G6PD deficiency; screen patients at risk for G6PD deficiency before initiating (eg, patients of African, Mediterranean [including Southern European and Middle Eastern], and Southern Asian ancestry); do not administer to patients with G6PD deficiency

    Gout flares may occur after initiating owing to changing serum uric acid levels resulting in mobilization of urate from tissue deposits; gout flare prophylaxis with an NSAID or colchicine is recommended starting at least 1 week before starting and during pegloticase treatment and for at least 6 months, unless medically contraindicated or not tolerated

    Exacerbation of pre-existing CHF reported; exercise caution when using this drug in patients who have congestive heart failure and monitor patients closely following infusion

    No controlled trial data are available regarding safety and efficacy of retreatment with pegloticase after stopping treatment for >4 weeks; owing to immunogenicity of pegloticase, patients receiving retreatment may be at increased risk of anaphylaxis and infusion reactions

    There are no adequate and well-controlled studies in pregnant women

    Not known whether drug is excreted in human milk


    8 mg IV infusion every 2 weeks.


    8 mg IV infusion every 2 weeks.


    Safety and efficacy have not been established.


    Safety and efficacy have not been established.


    Safety and efficacy have not been established.


    Safety and efficacy have not been established.


    injectable solution

    • 8mg/mL