Anaphylaxis and Infusion Reactions
- Anaphylaxis and infusion reactions have been reported to occur during and after administration of pegloticase.
- Pegloticase should be administered in heathcare 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 adminiatration of pegloticase
- 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 aboev 6 mg/dL are observed.
- During pre-marketing clinical trials, anaphylaxis was reported with a frequency of 6.5% (8/123) of patients treated with KRYSTEXXA every 2 weeks and 4.8% (6/126) for the every 4-week dosing regimen. There were no cases of anaphylaxis in patients receiving placebo. Anaphylaxis generally occurred within 2 hours after treatment. Diagnostic criteria of anaphylaxis were skin or mucosal tissue involvement, and, either airway compromise, and/or reduced blood pressure with or without associated symptoms, and a temporal relationship to KRYSTEXXA or placebo injection with no other identifiable cause.
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.
- The risk of anaphylaxis is higher in patients who have lost therapeutic response.
- Monitor serum acid levels prior to infusion and consider discontinuing treatment if levels increase to above 6 gm/dL, particularly when 2 consecutive levels aboev 6 mg/dL are observed.
- Patients should be observed for an appropriate period of time post-infusion.
Approved Risk Evaluation and Mitigation Strategies (REMS)
Patient Counseling Information
Updated August 2018