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Krystexxa (Pegloticase) - Summary

 
 



WARNING: ANAPHYLAXIS AND INFUSION REACTIONS

  • Anaphylaxis and infusion reactions have been reported to occur during and after administration of KRYSTEXXA. [see Warnings and Precautions (5.1, 5.2)]
  • Anaphylaxis may occur with any infusion, including a first infusion, and generally manifests within 2 hours 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 and infusion reactions.
  • Patients should be premedicated 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 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed.
 

KRYSTEXXA SUMMARY

KRYSTEXXA (pegloticase) is a uric acid specific enzyme which is a PEGylated product that consists of recombinant modified mammalian urate oxidase (uricase) produced by a genetically modified strain of Escherichia coli. Uricase is covalently conjugated to monomethoxypoly(ethylene glycol) [mPEG] (10 kDa molecular weight).

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 is not recommended for the treatment of asymptomatic hyperuricemia.


See all Krystexxa indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Krystexxa (Pegloticase)

Pegloticase for chronic gout. [2010]
CONCLUSIONS: There are no published double-blind, placebo-controlled

Improved health-related quality of life and physical function in patients with refractory chronic gout following treatment with pegloticase: evidence from phase III randomized controlled trials. [2012]
health-related quality of life (HRQOL) in patients with refractory chronic gout... CONCLUSION: Pegloticase therapy resulted in statistically significant and

Reduction of plasma urate levels following treatment with multiple doses of pegloticase (polyethylene glycol-conjugated uricase) in patients with treatment-failure gout: results of a phase II randomized study. [2008]
failed, and to assess the pharmacokinetics and safety of pegloticase... CONCLUSION: Pegloticase, administered in multiple doses, was effective in rapidly

more studies >>

Clinical Trials Related to Krystexxa (Pegloticase)

Observational Study of the Use of KRYSTEXXA� in Refractory Chronic Gout [Recruiting]
The primary purpose of this study is to observe patients being treated with KRYSTEXXA in a standard healthcare setting in order to evaluate the frequency and severity of infusion reactions, anaphylaxis and immune complex related events. Additionally, serious adverse events associated with KRYSTEXXA therapy will be identified.

Study to Assess Pegloticase (KRYSTEXXA�) in Patients on Hemodialysis [Completed]
This is a Phase 1 single dose study conducted to evaluate the PK and PD of pegloticase administered to hemodialysis patients. A single dose of pegloticase will be administered intravenously to male or female hemodialysis patients (N = 12) starting 3 hour prior to dialysis. The study consists of a Screening Period, a Treatment Period, and Follow up Period.

A Study of Persons With Gout Who Do Not Respond to or Are Allergic to Conventional Therapy [Completed]
This is a randomized, open-label, multicenter, parallel-groups study of multiple intravenous doses of Puricase, administered intravenously, in 40 patients with symptomatic gout. Subjects must wash out of any uric acid-lowering agents for one week before being dosed, and must refrain from using such agents throughout the study.

Safety and Efficacy Study of PEG-uricase in the Treatment of Hyperuricemic Patients With Symptomatic Gout [Completed]
These are two replicate studies to evaluate the safety and efficacy of PEG (polyethylene glycol)-uricase in controlling the uric acid level in symptomatic gout patients with high uric acid levels who are unable to take standard gout therapies, or for whom those therapies have been unsuccessful in controlling their uric acid level.

more trials >>

Reports of Suspected Krystexxa (Pegloticase) Side Effects

Infusion Related Reaction (35)Gout (28)Therapeutic Response Decreased (23)Nausea (9)Anaphylactic Reaction (8)Condition Aggravated (8)Dyspnoea (7)Chest Pain (5)Cerebrovascular Accident (5)Arthralgia (5)more >>


Page last updated: 2013-02-10

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