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Tophi (TOE-f-EYE) while on oral meds are telltale signs your gout is uncontrolled. When uric acid levels remain high, deposits of uric acid crystals can develop into hard visible lumps that damage your joints and bones. Tophi can be microscopic or large and, though rarely, may need to be surgically removed. It’s also possible for tophi to erupt on their own.
In clinical trials, more than half of patients treated with KRYSTEXXA with methotrexate had at least 1 tophus completely go away by Month 12, and they didn’t experience any new tophus growth.*
*Among patients who had tophi at baseline.
The best results for patients on KRYSTEXXA with methotrexate were seen in 6 to 12 months. Optimal treatment duration has not been established.
KRYSTEXXA can make a dramatic difference treating tophi. In clinical trials, more than half of patients treated with KRYSTEXXA with methotrexate had at least 1 tophus completely go away by Month 12, and they didn’t experience any new tophus growth.*
*Among patients who had tophi at baseline.
The best results for patients on KRYSTEXXA with methotrexate were seen in 6 to 12 months. Optimal treatment duration has not been established.
Tophi can be microscopic or large and, though rarely, may need to be surgically removed. It’s also possible for tophi to erupt on their own.
KRYSTEXXA can resolve tophi that form when uric acid crystals build up under your skin.
In clinical trials, more than half of patients treated with KRYSTEXXA with methotrexate had at least 1 tophus completely go away by Month 12, and they didn’t experience any new tophus growth.* Finishing all your treatments as your doctor prescribes is important to get the full benefit of KRYSTEXXA.
*Among patients who had tophi at baseline.
The best results for patients on KRYSTEXXA with methotrexate were seen in 6 to 12 months. Optimal treatment duration has not been established.
Only KRYSTEXXA lowers your uric acid level enough in just 24 hours to start dissolving gout buildup and tophi, or gouty lumps.
Unlike medicines you take daily for life, you’ll go for a KRYSTEXXA treatment every 2 weeks for 6 to 12 months or for as long as your doctor recommends.‡
‡Best results were seen after 6 to 12 months of treatment. However, optimal treatment duration has not been established.
What is the most important information I should know about KRYSTEXXA® (pegloticase)?
Serious allergic reactions may happen in some patients 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:
Who should not receive KRYSTEXXA?
Do not receive KRYSTEXXA if you:
What should I tell my doctor before receiving treatment with KRYSTEXXA?
Before you receive KRYSTEXXA, tell your doctor about all of your medical conditions, including if you:
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Do not take any other uric acid lowering drug, such as allopurinol, febuxostat (Uloric), or probenecid, while receiving KRYSTEXXA.
KRYSTEXXA is recommended to be given with another prescription medicine called methotrexate. KRYSTEXXA may also be used alone. You and your doctor will decide the treatment that is right for you.
Prior to your treatment with KRYSTEXXA, your doctor may give you medicine to help reduce your risk of getting gout flares or an allergic reaction. Take these medicines as directed by your doctor or nurse. Your doctor will also test your uric acid levels prior to each treatment to monitor your response to KRYSTEXXA.
Your gout flares may increase in the first 3 months when you start receiving KRYSTEXXA. It’s important to understand that this is happening because KRYSTEXXA is breaking down uric acid in your body. Do not stop receiving KRYSTEXXA even if you have a flare, as the amount of flares will decrease after 3 months of treatment. Your doctor may give you other medicines to help reduce your gout flares for the first few months after starting KRYSTEXXA.
What are the possible side effects of KRYSTEXXA?
In KRYSTEXXA clinical trials:
The most common side effects of
KRYSTEXXA
when given together with methotrexate were gout flares, joint pain,
coronavirus disease 2019
(COVID-19), nausea, and fatigue.
The most common side effects of KRYSTEXXA
were gout
flares, allergic reactions (including infusion reactions). See “What is the most
important information I
should know about KRYSTEXXA?”, nausea, bruising, sore throat, constipation, chest pain,
coronavirus disease
2019 (COVID-19), and vomiting.
This is not a complete list of all possible side
effects. Call your
doctor for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch or call 1-800-FDA-1088.
For additional Important Safety Information, please see the Medication Guide and discuss with your doctor.
KRYSTEXXA is a prescription medicine used in adults to help reduce the signs and symptoms of gout that are not controlled by other treatments.
KRYSTEXXA is not for use in people with too much uric acid in their bodies who do not have symptoms (asymptomatic hyperuricemia).
What is the most important information I should know about KRYSTEXXA?
Serious allergic reactions may happen in some patients who receive KRYSTEXXA. These allergic reactions can be life-threatening and usually happen within 2 hours of the infusion.