BlackBoxRX
 
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Pegloticase

Anaphylaxis and Infusion Reactions, G6PD Deficiency associated Hemolysis and Methemoglobinemia

  • Anaphylaxis and infusion reactions have been reported to occur during and after administration of pegloticase.
  • Pegloticase should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions.
  • Premedicate with antihistamines and corticosteroids and closely monitor for anaphylaxis for an appropriate period of time after administration of pegloticase.

MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA

  • 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.
  • Patients should be closely monitored for an appropriate period of time for anaphylaxis after adminiatration of pegloticase.
  • Monitor serum uric acid levels prior to each infusion and discontinue treatment if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed. 

PATIENT CARE PLAN

  • Screen patients at risk for G6PD deficiency prior to starting pegloticase. Hemolysis and methemoglobinemia have been reported with pegloticase in patients with G6PD deficiency. Pegloticase is contraindicated in patients with G6PD deficiency. 

Approved Risk Evaluation and Mitigation Strategies (REMS)

 

Patient Counseling Information

Medication Guides

Patient Medication Guide

Package Inserts

Krystexxa

KRYSTEXXA (pegloticase) injection, solution , FDA Daily Med

Updated August 2022