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KRYSTEXXA
Gout
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Drug Name:

KRYSTEXXA Rx

Generic Name and Formulations:
Pegloticase 8mg/mL (as uricase protein) in phosphate buffered saline; for IV infusion after dilution.

Company:
Horizon Pharma

Therapeutic Use:

Indications for KRYSTEXXA:

Chronic gout in adult patients refractory to conventional therapy.

Limitations Of use:

Not for treating asymptomatic hyperuricemia.

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. ≥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.

Children:

<18yrs: not recommended.

Contraindications:

G6PD deficiency.

Boxed Warning:

Anaphylaxis and infusion reactions. G6PD deficiency associated hemolysis. Methemoglobinemia.

Warnings/Precautions:

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.

Pharmacological Class:

PEGylated uric acid specific enzyme.

Adverse Reactions:

Gout flares (prophylax with colchicine and/or NSAIDs), infusion reactions, GI upset, contusion, ecchymosis, nasopharyngitis, constipation, chest pain, anaphylaxis, CHF exacerbation, antibody formation.

Generic Availability:

NO

How Supplied:

Single-use vial—1

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