IMPORTANT SAFETY INFORMATION
Krystexxa® (pegloticase) is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy. Gout refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated.
Important Limitations of Use: Krystexxa is not recommended for the treatment of asymptomatic hyperuricemia.
- Glucose-6-phosphate dehydrogenase (G6PD) Deficiency: Before starting Krystexxa, patients at higher risk for G6PD deficiency (e.g., those of African and Mediterranean ancestry) should be screened due to the risk of hemolysis and methemoglobinemia.
WARNINGS AND PRECAUTIONS
- Anaphylaxis: Anaphylaxis occurred in patients treated with Krystexxa. 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. Krystexxa should be administered in healthcare settings and by healthcare providers prepared to 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: Infusion reactions occurred in patients treated with Krystexxa. Krystexxa should be administered in a healthcare setting and by healthcare providers prepared to manage infusion reactions. Patients should be pre-medicated with antihistamines and corticosteroids. Monitor patients closely for signs and symptoms of infusion reactions. In the event of an infusion reaction, the infusion should be slowed, or stopped and restarted at a slower rate. If a severe infusion reaction occurs, discontinue infusion and institute treatment as needed. The risk of an infusion reaction is higher in patients who have lost therapeutic response.
- 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 above 6 mg/dL are observed.
- Concomitant use of Krystexxa and oral urate-lowering agents may blunt the rise of serum uric acid levels. It is recommended that patients discontinue oral urate-lowering agents and not institute therapy with oral urate-lowering agents while taking Krystexxa.
- Gout Flares: An increase in gout flares is frequently observed upon initiation of anti-hyperuricemia therapy, including treatment with Krystexxa. If a gout flare occurs during treatment, Krystexxa need not be discontinued. 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.
- Congestive Heart Failure: 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.
- Re-treatment: Patients receiving re-treatment may be at increased risk for anaphylaxis and infusion reactions and should be monitored carefully.
The most commonly reported serious adverse reactions are gout flares, infusion reactions and anaphylaxis. 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%). In addition to events occurring in greater than 5%, exacerbation of pre-existing congestive heart failure occurred in 2%.
To report SUSPECTED ADVERSE REACTIONS, contact Crealta Pharmaceuticals LLC at 1-888-579-7839 (1-888-KRYSTEXXA) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
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