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U.S. Department of Health and Human Services

Safety

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Krystexxa (Pegloticase) Injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2012

Summary View

 

WARNINGS AND PRECAUTIONS

Anaphylaxis
  • Because of the possibility that concomitant use of oral urate-lowering therapy and Krystexxa may potentially blunt the rise of serum uric acid levels, it is recommended that before starting Krystexxa patients discontinue oral urate-lowering medications and not institute therapy with oral urate-lowering agents while taking Krystexxa.
 
Infusion Reaction
  • Because of the possibility that concomitant use of oral urate-lowering therapy and Krystexxa may potentially blunt the rise of serum uric acid levels, it is recommended that before starting Krystexxa patients discontinue oral urate-lowering medications and not institute therapy with oral urate-lowering agents while taking Krystexxa.