Generic Name and Formulations:
Pegloticase 8mg/mL (as uricase protein) in phosphate buffered saline; for IV infusion after dilution.
Indications for KRYSTEXXA:
Chronic gout in adult patients refractory to conventional therapy.
Limitations Of use:
Not for treating asymptomatic hyperuricemia.
Discontinue oral urate-lowering agents before starting; do not institute while on pegloticase therapy. Premedicate with antihistamines and corticosteroids. Give by IV infusion over at least 2 hours. ≥18yrs: 8mg once every 2 weeks. Slow rate, or stop and restart at lower rate, if infusion reaction occurs; observe at least 1 hour post-infusion.
<18yrs: not recommended.
Anaphylaxis and infusion reactions. G6PD deficiency associated hemolysis. Methemoglobinemia.
Administer in healthcare setting by clinician prepared to manage infusion reactions and anaphylaxis. Monitor closely for anaphylaxis/infusion reactions for an appropriate period of time after administration and esp. in patients receiving retreatment after a drug-free interval >4 weeks. Monitor serum uric acid levels before each infusion; consider discontinuing when levels >6mg/dL, particularly with 2 consecutive levels >6mg/dL (increased risk of anaphylaxis and infusion reactions). Screen patients at risk for G6PD deficiency (African, Mediterranean, or Southern Asian descent) prior to starting. CHF. Pregnancy (Cat.C). Nursing mothers: not recommended.
PEGylated uric acid specific enzyme.
Gout flares (prophylax with colchicine and/or NSAIDs), infusion reactions, GI upset, contusion, ecchymosis, nasopharyngitis, constipation, chest pain, anaphylaxis, CHF exacerbation, antibody formation.