deg; to 8°C (36° to 46°F) and at room temperature (20° to 25°C, 68° to 77°F). However it is recommended that diluted solutions be stored under refrigeration, not frozen, protected from light, and used within 4 hours of dilution. [see How Supplied/Storage and Handling ( 16 )]
Before administration, allow the diluted solution of KRYSTEXXA to reach room temperature. KRYSTEXXA in a vial or in an intravenous infusion fluid should never be subjected to artificial heating (e.g., hot water, microwave).
2.3 Administration
Do not administer as an intravenous push or bolus.
Monitoring Therapy: The risk of anaphylaxis and infusion reactions is higher in patients who have lost therapeutic response. Monitor serum uric acid levels prior to infusions and consider discontinuing treatment if levels increase to above 6Â mg/dL, particularly when 2Â consecutive levels above 6Â mg/dL are observed. [see Warnings and Precautions ( 5.1 , 5.2 )]
The KRYSTEXXA admixture should only be administered by intravenous infusion over no less than 120Â minutes via gravity feed, syringe-type pump, or infusion pump.
Patients should receive pre-infusion medications (e.g. antihistamines, corticosteroids), to minimize the risk of anaphylaxis and infusion reactions. Administer KRYSTEXXA in a healthcare setting and by healthcare providers prepared to manage anaphylaxis and infusion reactions, and observe patients for an appropriate period of time after administration. [see Warnings and Precautions ( 5.1 , 5.2 )]
If an infusion reaction occurs during the administration of KRYSTEXXA, the infusion may be slowed, or stopped and restarted at a slower rate, at the discretion of the physician. Since infusion reactions can occur after completion of infusion, observation of patients for approximately an hour post-infusion should be considered. [see Warnings and Precautions ( 5.2 ), Adverse Reactions ( 6.1 )]
3 DOSAGE FORMS AND STRENGTHS
KRYSTEXXA is a clear, colorless, sterile 8Â mg/mL solution of pegloticase in a 2Â mL single-use vial, expressed as amounts of uricase protein. KRYSTEXXA must be diluted prior to use.
4 CONTRAINDICATIONS
Glucose-6-phosphate dehydrogenase (G6PD) deficiency: KRYSTEXXA is contraindicated in patients with G6PD deficiency due to the risk of hemolysis and methemoglobinemia. It is recommended that patients at higher risk for G6PD deficiency (e.g., patients of African or Mediterranean ancestry) be screened for G6PD deficiency before starting KRYSTEXXA.
5 WARNINGS AND PRECAUTIONS
5.1 Anaphylaxis
During pre-marketing controlled clinical trials, anaphylaxis was reported with a frequency of 6.5% of patients treated with KRYSTEXXA every 2Â weeks, compared to none with placebo. Manifestations included wheezing, peri-oral or lingual edema, or hemodynamic instability, with or without rash or urticaria. Cases occurred in patients being pre-treated with one or more doses of an oral antihistamine, an intravenous corticosteroid and/or acetaminophen. This pre-treatment may have blunted or obscured symptoms or signs of anaphylaxis and therefore the reported frequency may be an underestimate. [See Adverse Reactions ( 6 )]
KRYSTEXXA should be administered in a healthcare setting by healthcare providers prepared to manage anaphylaxis. Patients should be pre-treated with antihi |
