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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
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WARNING: ANAPHYLAXIS and INFUSION REACTIONS
See full prescribing information for complete boxed warning.
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Anaphylaxis and infusion reactions have been reported to occur during and after administration of KRYSTEXXA (5.1, 5.2).
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KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions.
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Patients should be pre-medicated with antihistamines and corticosteroids.
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Patients should be closely monitored for an appropriate period of time for anaphylaxis after administration of KRYSTEXXA.
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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.
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INDICATIONS AND USAGE
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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)
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DOSAGE AND ADMINISTRATION
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For adult patients 8mg given as an intravenous infusion every two weeks. (2.1)
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Do not administer as an intravenous push or bolus. (2.3)
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