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Krystexxa Generic Name & Formulations
Legal Class
Rx
General Description
Pegloticase 8mg/mL (as uricase protein) in phosphate buffered saline; for IV infusion after dilution.
Pharmacological Class
PEGylated uric acid specific enzyme.
How Supplied
Single-use vial—1
Manufacturer
Generic Availability
NO
Krystexxa Indications
Indications
Chronic gout in adult patients refractory to conventional therapy.
Limitations of Use
Not for treating asymptomatic hyperuricemia.
Krystexxa Dosage and Administration
Adult
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 via gravity feed, syringe-type pump, or infusion pump. ≥18yrs: 8mg once every 2 weeks, co-administered with weekly oral methotrexate 15mg and folic/folinic acid supplementation. May give pegloticase as monotherapy if methotrexate is contraindicated or not clinically appropriate. If co-administering with methotrexate, start weekly methotrexate and folic/folinic acid supplementation at least 4wks prior to initiation, and during treatment. Slow rate, or stop and restart at lower rate, if infusion reaction occurs; observe at least 1 hour post-infusion.
Children
<18yrs: not established.
Krystexxa Contraindications
Contraindications
G6PD deficiency.
Krystexxa Boxed Warnings
Boxed Warning
Anaphylaxis and infusion reactions. G6PD deficiency associated hemolysis. Methemoglobinemia.
Krystexxa Warnings/Precautions
Warnings/Precautions
Administer in healthcare setting by clinicians prepared to manage anaphylaxis and infusion reactions. Monitor closely for anaphylaxis/infusion reactions for an appropriate period of time after administration and esp. in those receiving retreatment after a drug-free interval >4 weeks. Monitor serum uric acid levels before each infusion; discontinue if levels increase to >6mg/dL, particularly with 2 consecutive levels >6mg/dL (increased risk of anaphylaxis and infusion reactions). Screen patients at risk for G6PD deficiency prior to initiation (eg, African, Mediterranean, or Southern Asian ancestry). Give gout flare prophylaxis for at least the first 6 months of pegloticase therapy. CHF. Pregnancy. Nursing mothers: not recommended.
Krystexxa Pharmacokinetics
See Literature
Krystexxa Interactions
Interactions
May be potentiated by methotrexate. May potentially bind with other PEGylated products.
Krystexxa Adverse Reactions
Adverse Reactions
Co-administered with methotrexate: gout flares, arthralgia, COVID-19, nausea, fatigue. As monotherapy: gout flares, infusion reactions, nausea, contusion, ecchymosis, nasopharyngitis, constipation, chest pain, anaphylaxis, vomiting.
Krystexxa Clinical Trials
See Literature
Krystexxa Note
Not Applicable
Krystexxa Patient Counseling
See Literature
