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Krystexxa
pegloticase
Black Box Warnings .
Appropriate Use
should only be administered in healthcare setting and by healthcare professionals prepared for management of anaphylaxis and infusion reactions
Anaphylaxis/Infusion Reactions
may occur with any infusion, including 1st one, and generally within 2h of infusion; delayed hypersensitivity reaction also reported; premed with 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, especially when 2 consecutive levels >6 mg/dL
G6PD Deficiency Associated Hemolysis and Methemoglobinemia
screen patients at risk for G6PD deficiency prior to use, including patients of African, Mediterranean, or South Asian descent; life-threatening hemolytic reactions and methemoglobinemia reported in patients with G6PD deficiency; do not administer to patients with G6PD deficiency
Adult Dosing .
Dosage forms: INJ
gout, refractory chronic
- [monotherapy]
- Dose: 8 mg IV q2wk; Info: start gout flare prophylaxis with NSAID or colchicine >1wk before pegloticase initiation and continue >6mo; D/C oral urate-lowering meds before and during tx; screen patients of African, Mediterranean, or South Asian ancestry for G6PD deficiency before initiating tx; premed with antihistamines, corticosteroids; D/C if serum uric acid levels incr. to >6 mg/dL, especially when 2 consecutive levels >6 mg/dL
- [combo with methotrexate]
- Dose: 8 mg IV q2wk; Info: start weekly methotrexate with folate supplementation at least 4wk before and continue during tx; start gout flare prophylaxis with NSAID or colchicine >1wk before pegloticase initiation and continue >6mo; D/C oral urate-lowering meds before and during tx; screen patients of African, Mediterranean, or South Asian ancestry for G6PD deficiency before initiating tx; premed with antihistamines, corticosteroids; D/C if serum uric acid levels incr. to >6 mg/dL, especially 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.