KRYSTEXXA™ (pegloticase) is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy.
Gout refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated.
Important Limitations of Use
KRYSTEXXA (pegloticase injection) is not recommended for the treatment of asymptomatic hyperuricemia.
DOSAGE AND ADMINISTRATION
The recommended dose and regimen of KRYSTEXXA (pegloticase injection) for adult patients is 8 mg (uricase protein) given as an intravenous infusion every two weeks.
The optimal treatment duration with KRYSTEXXA (pegloticase injection) has not been established.
Visually inspect KRYSTEXXA (pegloticase injection) for particulate matter and discoloration before administration, whenever solution and container permit. Do not use vials if either is present [see Dosage Forms and Strengths]
Use appropriate aseptic technique. Withdraw 1 mL of KRYSTEXXA (pegloticase injection) from the vial into a sterile syringe. Discard any unused portion of product remaining in the 2 mL vial. Inject into a single 250 mL bag of 0.9% Sodium Chloride Injection, USP or 0.45% Sodium Chloride Injection, USP for intravenous infusion. Do not mix or dilute with other drugs.
Invert the infusion bag containing the dilute KRYSTEXXA (pegloticase injection) solution a number of times to ensure thorough mixing. Do not shake.
KRYSTEXXA (pegloticase injection) diluted in infusion bags is stable for 4 hours at 2° 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]
Before administration, allow the diluted solution of KRYSTEXXA (pegloticase injection) to reach room temperature. KRYSTEXXA (pegloticase injection) in a vial or in an intravenous infusion fluid should never be subjected to artificial heating (e.g., hot water, microwave).
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 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed. [see WARNINGS AND PRECAUTIONS]
The KRYSTEXXA (pegloticase injection) admixture should only be administered by intravenous infusion over no less than 120 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 (pegloticase injection) 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]
If an infusion reaction occurs during the administration of KRYSTEXXA (pegloticase injection) , 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, ADVERSE REACTIONS]
Dosage Forms And Strengths
KRYSTEXXA is a clear, colorless, sterile 8 mg/mL solution of pegloticase in a 2 mL single-use vial, expressed as amounts of uricase protein. KRYSTEXXA (pegloticase injection) must be diluted prior to use.
KRYSTEXXA (pegloticase injection) is supplied as a clear, colorless, sterile solution in phosphate buffered saline intended for intravenous infusion after dilution. KRYSTEXXA (pegloticase injection) is supplied in a single-use 2 mL glass vial with a Teflon® coated (latex-free) rubber injection stopper to deliver KRYSTEXXA (pegloticase injection) as 8 mg of uricase protein in 1 mL volume.
Storage and Handling
Before the preparation for use, KRYSTEXXA (pegloticase injection) must be stored in the carton and maintained at all times under refrigeration between 2° to 8°C (36° to 46°F). Protect from light. Do not shake or freeze.
Do not use beyond the expiration date stamped.
Manufactured by: Savient Pharmaceuticals, Inc. One Tower Center, 14th Floor East Brunswick, NJ 08816. Issued September 2010
Last reviewed on RxList: 7/12/2012
This monograph has been modified to include the generic and brand name in many instances.
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