A lot of people who are learning about KRYSTEXXA have similar questions. If there’s something you’d like to know that hasn’t been covered on our website, a Gout Nurse Advocate will be happy to help. Call 1-833-4MY-GOUT (1-833-469-4688) Monday through Friday from 8:00 AM to 11:00 PM ET.

Understanding gout

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Chronic gout is gout that continues to produce signs and symptoms, such as gout flares, due to ongoing gout crystal deposits.

If you take conventional uric acid–lowering medicine and have more than 1 gout flare a year—or at least 1 visible lump (tophus) on your body—your gout may be out of control. See what can happen when gout is out of control.

If you take oral gout medicine and still experience gout symptoms, your gout may be out of control. 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.

In addition to more frequent and severe gout flares, out-of-control chronic gout has been linked to serious health issues. Lumps of uric acid crystal buildup, called tophi, can develop over time and lead to other complications.

Gout causes

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Gout is caused by too much uric acid in your blood. It’s rarely caused by diet, though certain foods can trigger a gout attack. Over time, uric acid crystals can form and settle in your joints. If gout remains out of control, it could lead to permanent joint and bone damage.

Uric acid is produced when your body breaks down purines found naturally in your body and in certain 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 remove too little, the uric acid can form into tiny needle-like crystals that settle in your joints and surrounding tissues. KRYSTEXXA works differently to lower your uric acid level and help 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. There’s evidence that gout may be associated with an increased risk of kidney disease progression.

Understanding gout and chronic kidney disease (CKD)

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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 other joints, that may be a sign that your gout is out of control. Ask your nephrologist if a blood test to measure your uric acid levels is an option for you. If oral gout medicines are not doing enough to control your gout, ask your nephrologist about KRYSTEXXA.

When you have gout, uric acid can form into crystals that build up in organs such as the kidneys. The crystals can cause kidney
damage or make kidney disease even worse. About 1 in 4 people with moderate-to-severe kidney disease also has gout. Diseased kidneys can have a harder time removing uric acid.

Oral gout medications may be enough to control gout. But, if gout is out of control, the medicine may not lower your uric acid level enough to stop gout symptoms. Over the years, uric acid builds up in your blood and can form crystals. This can cause complications in the joints and organs like your kidneys.*

*KRYSTEXXA has not been studied to remove urate deposition from any of the body's organs.

If you are taking an oral medication for your out-of-control gout and are still experiencing more than 1 flare or the presence of tophi in the last 12 months, it might be time to try another treatment option. Talk to your nephrologist or doctor to get more information.

KRYSTEXXA was tested in patients with mild-to-moderate chronic kidney disease . It has been shown to be effective and has a proven safety profile.

Gout signs and symptoms

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When uric acid crystals build up in your joints you can develop gout flares. Gout flares cause inflammation, redness, swelling, tenderness, and intense pain. Visible lumps called tophi can also form. Your doctor will test your uric acid level to determine whether or not your signs and symptoms are the result of gout.

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 out of control.

Tophi (TOE-f-EYE) are hard lumps of uric acid crystals that build up so much they become visible. The big toe is a common place to develop tophi. They can also form on your hands, elbows, and knees—and almost anywhere else, even in your organs. Anyone with gout is at risk of developing tophi if gout stays out of control for too long.

Gout duration

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Even when you’re not having a flare, you still have the underlying condition that causes gout. Take control of chronic gout by dissolving uric acid crystal buildup and keeping your uric acid level low enough to prevent new buildup.

Once your joints and bones are damaged, it’s permanent. The risk of joint and bone damage increases as gout builds up in your joints.

Taking KRYSTEXXA

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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 compared to those who used KRYSTEXXA alone at Month 12.
  • KRYSTEXXA works better with methotrexate to reduce infusion reactions so you can stay on treatment longer, 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 is effective when used alone.

KRYSTEXXA is a delicate enzyme that would be destroyed in your stomach if taken as a pill.

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.

Learn more about how KRYSTEXXA works with a medication called methotrexate.

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.

Your doctor will determine if methotrexate is right for you based on your medical information. 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 starts working within 24 hours. People in the clinical studies were given KRYSTEXXA for 6 to 12 months in order to stay in the dissolve zone to get rid of years of uric acid crystal buildup.

Best results were seen after 6 to 12 months of treatment. Optimal treatment duration has not been established.

Not necessarily. KRYSTEXXA works well alone to lower uric acid levels in the blood as soon as 24 hours after the first IV treatment. However, 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.

You and your doctor will decide on a plan to keep uric acid crystals from building up again.

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 once a week by mouth

Once your KRYSTEXXA IV treatments begin, they will continue every 2 weeks for a length of time your doctor determines.

Staying on KRYSTEXXA

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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.

§Best results were seen after 6 to 12 months of treatment. Optimal treatment duration has not been established.

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 is effective when taken alone.

Best results were seen within 6-12 months, however, optimal treatment duration has not been established with KRYSTEXXA.

KRYSTEXXA side effects

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With KRYSTEXXA, gout flares are a common side effect, but many people in the clinical 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 any 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 assistant will be with you to ensure any infusion reactions are treated. In the clinical 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®.

USE AND IMPORTANT SAFETY INFORMATION

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.

USE AND IMPORTANT SAFETY INFORMATION

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:

  • wheezing, shortness of breath, cough, chest tightness, chest pain, or trouble breathing
  • dizziness, fainting, fast or weak heartbeat or feeling nervous
  • reddening of the face, itching, hives, or feeling warm
  • swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing

Who should not receive KRYSTEXXA?

Do not receive KRYSTEXXA if you:

  • have a rare blood problem called glucose-6-phosphate dehydrogenase (G6PD) deficiency or favism. Your doctor may test you for G6PD before you start KRYSTEXXA.
  • have had a serious allergic reaction to KRYSTEXXA or any of its ingredients. See the end of the Medication Guide for a complete list of ingredients in KRYSTEXXA.

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:

  • ever had any heart problems or high blood pressure.
  • are pregnant or plan to become pregnant. It is not known if KRYSTEXXA will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if KRYSTEXXA passes into your breast milk. You and your doctor should decide if you will receive KRYSTEXXA or breastfeed.

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.

USE

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).

USE AND IMPORTANT SAFETY INFORMATION

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.

USE AND IMPORTANT SAFETY INFORMATION

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:

  • wheezing, shortness of breath, cough, chest tightness, chest pain, or trouble breathing
  • dizziness, fainting, fast or weak heartbeat or feeling nervous
  • reddening of the face, itching, hives, or feeling warm
  • swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing

Who should not receive KRYSTEXXA?

Do not receive KRYSTEXXA if you:

  • have a rare blood problem called glucose-6-phosphate dehydrogenase (G6PD) deficiency or favism. Your doctor may test you for G6PD before you start KRYSTEXXA.
  • have had a serious allergic reaction to KRYSTEXXA or any of its ingredients. See the end of the Medication Guide for a complete list of ingredients in KRYSTEXXA.

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:

  • ever had any heart problems or high blood pressure.
  • are pregnant or plan to become pregnant. It is not known if KRYSTEXXA will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if KRYSTEXXA passes into your breast milk. You and your doctor should decide if you will receive KRYSTEXXA or breastfeed.

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.

USE

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).