KRYSTEXXA is a prescription medicine used in adults to help reduce the signs and symptoms of gout that are not controlled by other treatments. Read More
Chronic gout is gout that continues to produce signs and symptoms, such as gout flares, due to ongoing gout crystal deposits.
Uncontrolled gout is a form of gout that isn’t well managed with your current gout treatment. It’s more than just flareups. If you have a uric acid level over 6 mg/dL plus more than 1 flare a year and/or gouty lumps whole on oral gout medicine, you may have uncontrolled gout. Uncontrolled gout can cause damage to the joints, bones, and organs, such as the heart or kidneys.*
Learn what can happen if uncontrolled gout goes untreated. Take a quick quiz to see if you have uncontrolled gout.
*KRYSTEXXA has not been studied to reverse damage to the joints, bones, heart, kidneys, or any of the body's organs.
If you take oral gout medicine and still experience gout symptoms, your gout may be uncontrolled. Your flares may also become more frequent and severe or occur in other joints, or you may develop visible lumps of uric acid crystal buildup (tophi). Take a short quiz.
Uncontrolled gout can cause frequent and severe gout flareups. Uric acid crystals can build up inside your body around bones, joints, and organs and lead to damage.*
*KRYSTEXXA has not been studied to reverse damage to the joints, bones, heart, kidneys, or any of the body's organs.
Gout is caused by high levels of uric acid in your blood. It’s rarely caused by diet alone, though certain foods can trigger a gout attack. Over time, uric acid crystals can form and settle in your joints and other areas of your body. If gout remains uncontrolled, it could lead to permanent joint and bone damage.
KRYSTEXXA has not been studied to reverse damage to the joints, bones, or any of the body's organs.
Uric acid is produced when your body breaks down purines—natural substances found in your body and in some foods. Normally, uric acid dissolves in your blood and is removed through your kidneys. Even healthy kidneys only get rid of about 10% of the uric acid they process. Kidney disease can make it even more difficult to get rid of uric acid. However, if you produce too much uric acid or your kidneys don't remove enough, then the uric acid can form into tiny needle-like crystals that settle in your joints and surrounding tissues. KRYSTEXXA helps lower your uric acid level and resolve tophi that form when uric acid crystals build up.
Many people who have kidney disease can develop gout because diseased kidneys have a harder time removing uric acid from the blood. When too much uric acid builds up, uric acid crystals start to form, settle in joints, and cause painful gout attacks. Finding a medication that can lower your uric acid level is important.
KRYSTEXXA is not indicated to treat pain.
About 1 in 4 people with moderate to severe kidney disease also has gout. When you have chronic kidney disease, your kidneys don’t work as well as they should to remove uric acid from the body. Too much uric acid in your blood can cause gout.
If you are taking oral medicines for gout, and still having flares or pain and swelling in your hands, feet, or If you are taking gout pills and still having flares or pain and swelling in your hands, feet, or joints, that may be a sign that your gout is uncontrolled. Ask your nephrologist if a blood test to measure your uric acid levels is an option for you. If gout pills are not doing enough to control your gout, ask your nephrologist about KRYSTEXXA.
Gout pills may work well enough to control gout. But, if your uric acid is still too high and you are also having flares and/or tophi, you may need a different treatment. Uric acid builds up over time and can form into painful tophi made of crystals. These crystals can cause damage in your bones, joints, and organs, such as in the kidneys.*
*KRYSTEXXA has not been studied to reverse damage to the bones, joints, kidneys, or any of the body's organs.
If you are taking gout pills and are still having flares, you may have uncontrolled gout. Ask your nephrologist or gout specialist if you should have a blood test to measure your uric acid level.
KRYSTEXXA has also been shown to work in people with chronic kidney disease. In patient studies, patients with mild to moderate CKD had similar results to those without kidney disease.*
*KRYSTEXXA has not been studied to reverse damage to the kidneys.
When uric acid crystals build up in your joints, you can develop gout flares. Gout flares cause inflammation, redness, swelling, tenderness, and intense pain. Gouty lumps called tophi can also form under your skin or on some organs. Your doctor will test your uric acid level to determine whether or not your signs and symptoms are the result of uncontrolled gout.
*KRYSTEXXA has not been studied to reverse damage to any of the body's organs.
Over time, uric acid crystals can accumulate in new areas of your body, causing you to experience flares and damage in more places. That’s one sign your gout is uncontrolled.
Tophi (TOE-f-EYE) are hard lumps of uric acid crystals that build up over time—some may be visible, while others remain hidden beneath the surface. Tophi commonly form on the big toe or fingers. They can appear on other areas of the body, such as on the elbows or knees, too. Anyone with gout is at risk of developing tophi if gout stays uncontrolled for too long.
Yes, uric acid crystal buildup has been observed on the heart. Uncontrolled gout can spread beyond the joints to almost anywhere throughout the body.
KRYSTEXXA has not been studied to remove urate deposition from the heart.
Though uncommon, small tophi, or gouty lumps, can form on your outer ear.
Yes, uric acid crystal buildup has been observed on the spine.
Yes, tophi, or gouty lumps, on your elbows can become large and painful.
Even when you’re not having a flare, you still have the underlying condition that causes gout. Take control of uncontrolled gout by dissolving uric acid crystal buildup and keeping your uric acid level low enough to prevent new buildup.
KRYSTEXXA can make a dramatic difference treating tophi. In patient 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.*,†
*KRYSTEXXA has not been studied to reverse damage to any of the body's organs.
*Among patients who had tophi at the start of the study.
†Best results were seen after 6 to 12 months of treatment. Optimal treatment duration has not been established.
Tophi can be very small or very large. They can be removed by surgery, though that is rare.
By lowering uric acid levels, KRYSTEXXA can resolve tophi that form when uric acid crystals build up under your skin.
Joint and bone damage caused by uncontrolled gout can create lasting damage.
*KRYSTEXXA has not been studied to reverse damage to any of the body's organs.
KRYSTEXXA is a delicate enzyme that would be destroyed in your stomach if taken as a pill.
KRYSTEXXA is a biologic treatment, which means it’s made from a living source. Some biologics are delivered directly into the bloodstream via an intravenous (IV) infusion that you can receive in a variety of settings.
KRYSTEXXA is the first FDA-approved treatment for uncontrolled gout. It’s been used for more than 15 years to help lower uric acid and dissolve the uric acid crystal buildup that can cause flares and joint damage.
*KRYSTEXXA has not been studied to reverse damage to the joints or any of the body's organs.
While taking KRYSTEXXA, do not take any other uric acid–lowering drugs, such as Zyloprim® (allopurinol) or Uloric® (febuxostat). Your doctor or gout specialist may give you medicine (colchicine and/or NSAIDs) to help with any gout flares you may have while on KRYSTEXXA. In preparation for your KRYSTEXXA IV treatment, your doctor may also give you antihistamines and corticosteroids.
In patient studies, the best results were seen after 6 to 12 months of treatment. KRYSTEXXA starts working within 24 hours. The optimal treatment duration with KRYSTEXXA has not been established.
Do not take any other uric acid–lowering drugs, such as Zyloprim® (allopurinol) or Uloric® (febuxostat), while taking KRYSTEXXA. Your doctor or gout specialist may give you medicine (colchicine and/or NSAIDs) to help with gout flares you may have while on KRYSTEXXA. In preparation for your KRYSTEXXA IV treatment, your doctor may also give you antihistamines and corticosteroids to help reduce the chance of allergic reactions.
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In clinical studies, the best results were seen after 6 to 12 months of treatment. KRYSTEXXA starts working within 24 hours.
Your doctor may prescribe an oral medicine called methotrexate to take with KRYSTEXXA to help reduce symptoms of uncontrolled gout.
Studies show:
Patients who took KRYSTEXXA with methotrexate saw the best results at 6 to 12 months of treatment.*
Patients who took KRYSTEXXA with methotrexate had more reductions in tophi (gouty lumps) compared to those who used KRYSTEXXA alone at Month 12.
In a study, 71% of people (71/100) taking KRYSTEXXA with methotrexate vs 39% of patients (20/52) taking KRYSTEXXA alone kept uric acid levels under control at Month 6.
54% of people (28/52) receiving KRYSTEXXA with methotrexate dissolved at least 1 gouty lump compared to 31% of people (9/29) on KRYSTEXXA alone at Month 12.
Methotrexate reduces infusion reactions and can help allow KRYSTEXXA to keep working to lower uric acid levels. So you can stay on treatment for as long as your doctor recommends, which helps lower uric acid levels more effectively.
†Optimal treatment duration has not been established.
Methotrexate improves the way KRYSTEXXA works.Yes. If you and your doctor determine methotrexate is not right for you, KRYSTEXXA can be effective even when used alone.
Not necessarily. Some medicines, like KRYSTEXXA, may cause your immune system to overreact in response to them and create antidrug antibodies (ADAs), which can stop KRYSTEXXA from working. The use of methotrexate can help prevent ADAs from forming and allow you to continue your course of treatment.
If you and your doctor decide that KRYSTEXXA with methotrexate is an appropriate treatment, 4 weeks prior to starting KRYSTEXXA your doctor will prescribe
Folic acid to be taken daily by mouth
Methotrexate to be taken weekly by mouth
Once your KRYSTEXXA treatments begin, methotrexate and folic acid will continue to be taken throughout your treatment, or as your doctor prescribes.
Your doctor will determine if methotrexate is right for you based on your medical history. 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, or probenecid, while receiving KRYSTEXXA.
Since KRYSTEXXA is an IV treatment that’s delivered directly into your bloodstream, it has to be given to you by a nurse or other trained professional. Some doctors do it in their offices. If yours does not, you can go to an IV treatment center or hospital.
You and your doctor will decide on a plan to keep uric acid crystals from building up again.
Yes. People in the clinical studies had the best results when they were given KRYSTEXXA every 2 weeks for 6 to 12 months.* It’s important to finish all your treatments as directed by your doctor.
Making time for your IV treatments can be challenging, but in order to see the best results with KRYSTEXXA, it’s important to receive your IV treatment every 2 weeks. If you are going to miss an appointment, contact your doctor or gout specialist as soon as possible to reschedule.
Methotrexate can be taken with KRYSTEXXA until your KRYSTEXXA treatment is complete.* If during treatment you and your doctor determine methotrexate is not right for you, KRYSTEXXA can be effective even when taken alone.
Best results were seen after 6 to 12 months of treatment. Optimal treatment duration has not been established.
With KRYSTEXXA, gout flares are initially a common side effect, but many people in the medical studies said they were having fewer flares by the end of treatment. Your doctor may give you medicine (colchicine and/or NSAIDs) to help with gout flares you may have while on KRYSTEXXA.
The most common side effects of KRYSTEXXA when given with methotrexate were gout flares, joint pain, coronavirus disease 2019 (COVID-19), nausea, and fatigue.
A nurse or other healthcare provider will be with you to ensure any infusion reactions are treated promptly. In the patient studies, all infusion reactions, including serious infusion reactions, were treated at the IV treatment center with medicine or by stopping the IV treatment. Most were resolved using common medications such as Benadryl®.
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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 Full Prescribing Information, including Boxed Warning and 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® (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.