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.
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.
Not for treating asymptomatic hyperuricemia. Screen patients at risk for G6PD deficiency (African, Mediterranean, or Southern Asian descent) prior to starting. Administer in healthcare setting by clinician prepared to manage infusion reactions and anaphylaxis. Monitor closely for anaphylaxis/ infusion reactions, esp. in patients receiving retreatment after a drug-free interval >4 weeks. CHF. 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). Pregnancy (Cat.C). Nursing mothers: not recommended.
PEGylated uric acid specific enzyme.
Gout flares (prophylax with NSAIDs or colchicine), infusion reactions, GI upset, contusion, ecchymosis, nasopharyngitis, constipation, chest pain, anaphylaxis, CHF exacerbation, antibody formation.