Important Safety Information
KRYSTEXXA is for adults who have tried or can not take oral gout medicines and still have high uric acid levels and gout signs and symptoms, also known as Refractory Chronic Gout.
KRYSTEXXA is not recommended if you have high levels of uric acid without signs and symptoms of gout.
You should not use KRYSTEXXA if you have a genetic condition known as G6PD deficiency, which stands for glucose-6-phosphate dehydrogenase deficiency. This is also known as favism. G6PD deficiency occurs more often in people of African or Mediterranean family background. However, it can occur in anyone. Before giving you KRYSTEXXA, your doctor may give you a blood test to determine if you have G6PD deficiency.
Before you receive KRYSTEXXA, tell your doctor if you:
Know you have G6PD deficiency
Serious allergic reactions may happen in some people who receive KRYSTEXXA. These allergic reactions can be life threatening and usually happen within 2 hours of the infusion.
KRYSTEXXA should be given to you by a doctor or nurse in a healthcare setting where serious allergic reactions can be treated. Your doctor or nurse should watch you for any signs of a serious allergic reaction during and after your treatment with KRYSTEXXA.
Tell your doctor or nurse right away if you have any of these symptoms during or after your treatment with KRYSTEXXA:
Wheezing, shortness of breath, cough, chest tightness, chest pain, or trouble breathing
The most common serious side effects in patients taking KRYSTEXXA were severe allergic reactions and infusion reactions. The most common side effects were gout flare-ups or attacks, infusion reactions, nausea, bruising, sore throat, constipation, chest pain, severe allergic reactions, and vomiting.
An increase in gout flares is frequently observed in patients when they start taking medicines to lower their uric acid levels. Patients do not need to stop taking KRYSTEXXA simply because of gout flares.
This is not a complete list of all possible side effects. Ask your doctor or treatment team if you have any questions or want more information.
If you have any questions about KRYSTEXXA or your therapy, talk with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch, or call the FDA at 1-800-FDA-1088.
Please see the Medication Guide and Prescribing Information, including Boxed Warning, for more information.
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简介： 2010年9月14日，FDA批准治疗痛风的新药Krystexxa(pegloticase)，用于常规治疗无效或常规治疗无法耐受的成年痛风患者。 痛风为嘌呤代谢紊乱和(或)尿酸排泄障碍所致血尿酸增高的一组异质性疾病。过多的尿酸 ...