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Krystexxa
pegloticase
Black Box Warnings .
Appropriate Use
admin. only in healthcare setting and by healthcare professionals prepared for management of anaphylaxis and infusion rxns
Anaphylaxis/Infusion Rxns
may occur w/ any infusion, incl. 1st one, and generally w/in 2h of infusion; delayed hypersensitivity rxn also reported; premed w/ antihistamines, corticosteroids; closely monitor for appropriate time period after infusion; monitor serum uric acid levels before each infusion and D/C tx if levels incr. to >6 mg/dL, esp. when 2 consecutive levels >6 mg/dL
G6PD Deficiency Associated Hemolysis and Methemoglobinemia
screen pts at risk for G6PD deficiency prior to use, incl. pts of African, Mediterranean, or South Asian descent; life-threatening hemolytic rxns and methemoglobinemia reported in pts w/ G6PD deficiency; do not admin. to pts w/ G6PD deficiency
Adult Dosing .
Dosage forms: INJ
gout, refractory chronic
- [monotherapy]
- Dose: 8 mg IV q2wk; Info: start gout flare prophylaxis w/ NSAID or colchicine >1wk before pegloticase initiation and cont. >6mo; D/C oral urate-lowering meds before and during tx; screen pts of African, Mediterranean, or South Asian ancestry for G6PD deficiency before initiating tx; premed w/ antihistamines, corticosteroids; D/C if serum uric acid levels incr. to >6 mg/dL, esp. when 2 consecutive levels >6 mg/dL
- [combo w/ methotrexate]
- Dose: 8 mg IV q2wk; Info: start weekly methotrexate w/ folate supplementation at least 4wk before and cont. during tx; start gout flare prophylaxis w/ NSAID or colchicine >1wk before pegloticase initiation and cont. >6mo; D/C oral urate-lowering meds before and during tx; screen pts of African, Mediterranean, or South Asian ancestry for G6PD deficiency before initiating tx; premed w/ antihistamines, corticosteroids; D/C if serum uric acid levels incr. to >6 mg/dL, esp. when 2 consecutive levels >6 mg/dL
renal dosing
- [see below]
- renal impairment: no adjustment
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.