HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use KRYSTEXXA safely and effectively. See full prescribing information for KRYSTEXXA
KRYSTEXXA™ (pegloticase)
Injection, for intravenous infusion
Initial U.S. Approval: 2010
WARNING: ANAPHYLAXIS and INFUSION REACTIONS
See full prescribing information for complete boxed warning.
Anaphylaxis and infusion reactions have been reported to occur during and after administration of KRYSTEXXA (5.1, 5.2).
KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions.
Patients should be pre-medicated with antihistamines and corticosteroids.
Patients should be closely monitored for an appropriate period of time for anaphylaxis after administration of KRYSTEXXA.
Monitor serum uric acid levels prior to infusions and consider discontinuing treatment if levels increase to above 6mg/dL, particularly when 2consecutive levels above 6mg/dL are observed.
INDICATIONS AND USAGE
KRYSTEXXA™ (pegloticase) is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy. (1)
Important Limitations of Use:
KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia. (1)
DOSAGE AND ADMINISTRATION
For adult patients 8mg given as an intravenous infusion every two weeks. (2.1)
Do not administer as an intravenous push or bolus. (2.3)
Monitor serum uric acid levels before each infusion. (2.3)
Patients should be pre-medicated with antihistamines and corticosteroids. (2.3, 5.1, 5.2)
Administer in a healthcare setting by healthcare providers prepared to manage anaphylaxis. (2.3, 5.1, 5.2)
The KRYSTEXXA admixture should only be administered by intravenous infusion over no less than 120minutes via gravity feed, syringe-type pump, or infusion pump. (2.3)
DOSAGE FORMS AND STRENGTHS
1mL sterile concentrate for dilution containing 8mg of pegloticase protein, expressed in uricase protein amounts. (3
CONTRAINDICATIONS
Glucose-6-phosphate dehydrogenase (G6PD) Deficiency: Before starting KRYSTEXXA, patients at higher risk for G6PD deficiency (e.g.,those of African and Mediterranean ancestry) should be screened due to the risk of hemolysis and methemoglobinemia. (4)
WARNINGS AND PRECAUTIONS
Anaphylaxis: Anaphylaxis occurred in patients treated with KRYSTEXXA. Anaphylaxis may occur with any infusion, including a first infusion, and generally manifests within 2hours of the infusion. However, delayed-type hypersensitivity reactions have also been reported. KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis. Patients should be pre-medicated with antihistamines and corticosteroids. Patients should be closely monitored for an appropriate period of time for anaphylaxis after administration of KRYSTEXXA. (5.1)
Infusion Reactions: Infusion reactions occurred in patients treated with KRYSTEXXA. KRYSTEXXA should be administered in a healthcare setting and by healthcare providers prepared to manage infusion reactions. Patients should be pre-medicated with antihistamines and corticosteroids. Monitor patients closely for signs and symptoms of infusion reactions. In the event of an infusion reaction, the infusion should be s