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Savient Pharmaceuticals Announces New Data Surrounding KRYSTEXXA® and the Impact of Refractory Chronic Gout at the American College of Rheumatology Meeting
Date:11/5/2011

manage anaphylaxis. Patients should be pre-medicated with antihistamines and corticosteroids. Patients should be closely monitored for an appropriate period of time for anaphylaxis after administration of KRYSTEXXA.
  • Infusion reactions which occurred in some patients treated with KRYSTEXXA. The risk of an infusion reaction is higher in patients who have lost therapeutic response. Because the risk of infusion reactions is higher in patients who lose therapeutic response to KRYSTEXXA, monitor serum uric acid before each infusion and consider discontinuing treatment if levels rise above 6 mg/dL, particularly when two consecutive levels above
    mg/dL are observed.

  • As with other urate-lowering therapies, an increase in gout flares was seen in some patients treated with KRYSTEXXA. Gout flare prophylaxis with a non-steroidal anti-inflammatory drug (NSAID) or colchicine is recommended starting at least 1 week before initiation of KRYSTEXXA therapy and lasting at least 6 months, unless medically contraindicated or not tolerated.

  • KRYSTEXXA has not been formally studied in patients with congestive heart failure, but some patients in clinical trials experienced exacerbation. Exercise caution when using KRYSTEXXA in patients who have congestive heart failure and monitor patients closely following infusion. Patients receiving re-treatment may be at increased risk for anaphylaxis and infusion reactions and should be monitored carefully.

    ADVERSE REACTIONSThe most commonly reported serious adverse reactions are anaphylaxis, infusion reactions and gout flares. Most common adverse reactions: gout flares (77%), infusion reactions (26%), nausea (12%), contusion or ecchymosis (11%), nasopharyngitis (7%), constipation (6%), chest pain (6%), anaphylaxis (5%), and vomiting (5%).

    Please see the Full Prescribing Information and Medication Guide at http://www.krystexxa.com/.

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    SOURCE Savient Pharmaceuticals, Inc.
    Copyright©2010 PR Newswire.
    All rights reserved

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    5. Savient Pharmaceuticals Announces Publication of Pivotal Phase III KRYSTEXXA® Data in JAMA Demonstrating Significant Benefits in Refractory Chronic Gout Patients
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