stamines and corticosteroids. Anaphylaxis may occur with any infusion, including a first infusion, and generally manifests within 2Â 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 administration of KRYSTEXXA. Patients should be informed of the symptoms and signs of anaphylaxis and instructed to seek immediate medical care should anaphylaxis occur after discharge from the healthcare setting.
The risk of anaphylaxis is higher in patients whose uric acid level increases to above 6Â mg/dL, particularly when 2Â consecutive levels above 6Â mg/dL are observed. Monitor serum uric acid levels prior to infusions and consider discontinuing treatment if levels increase to above 6Â mg/dL.
5.2 Infusion Reactions
During pre-marketing controlled clinical trials, infusion reactions were reported in 26% of patients treated with KRYSTEXXA 8Â mg every 2Â weeks, and 41% of patients treated with KRYSTEXXA 8Â mg every 4Â weeks, compared to 5% of patients treated with placebo. These infusion reactions occurred in patients being pre-treated with an oral antihistamine, intravenous corticosteroid and/or acetaminophen. This pre-treatment may have blunted or obscured symptoms or signs of infusion reactions and therefore the reported frequency may be an underestimate. [See Adverse Reactions ( 6 )]
KRYSTEXXA should be administered in a healthcare setting by healthcare providers prepared to manage infusion reactions. Patients should be pre-treated with antihistamines and corticosteroids. KRYSTEXXA should be infused slowly over no less than 120Â minutes. In the event of an infusion reaction, the infusion should be slowed, or stopped and restarted at a slower rate.
The risk of infusion reaction is higher in patients whose uric acid level increases to above 6Â mg/dL, particularly when 2Â consecutive levels above 6Â mg/dL are observed. Monitor serum uric acid levels prior to infusions and consider discontinuing treatment if levels increase to above 6Â mg/dL.
5.3 Gout Flares
Gout flares may occur after initiation of KRYSTEXXA. [see Adverse Reactions ( 6.1 )] An increase in gout flares is frequently observed upon initiation of anti-hyperuricemic therapy, due to changing serum uric acid levels resulting in mobilization of urate from tissue deposits. Gout flare prophylaxis with a non-steroidal anti-inflammatory drug (NSAID) or colchicine is recommended starting at least 1Â week before initiation of KRYSTEXXA therapy and lasting at least 6Â months, unless medically contraindicated or not tolerated. KRYSTEXXA does not need to be discontinued because of a gout flare. The gout flare should be managed concurrently as appropriate for the individual patient. [see Dosage and Administration ( 2 )]
5.4 Congestive Heart Failure
KRYSTEXXA has not been formally studied in patients with congestive heart failure, but some patients in the clinical trials experienced exacerbation. [see Adverse Reactions ( 6.1 )] Exercise caution when using KRYSTEXXA in patients who have congestive heart failure and monitor patients closely following infusion.
5.5 Re-treatment with KRYSTEXXA
No controlled trial data are available on the safety and efficacy of re-treatment with KRYSTEXXA after stopping treatment for longer than 4 weeks. Due to t |
