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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

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KRYSTEXXA Side Effects

What are the possible side effects of KRYSTEXXA?

In KRYSTEXXA clinical trials:

The most common side effects of KRYSTEXXA when given with methotrexate were:

  • Gout flares
  • Joint pain
  • Coronavirus disease 2019 (COVID-19)
  • Nausea
  • Fatigue

The most common side effects of KRYSTEXXA were:

  • Gout flares
  • Allergic reactions (including infusion reactions)
  • Nausea
  • Bruising
  • Sore Throat
  • Constipation
  • Chest pain
  • Coronavirus disease 2019 (COVID-19)
  • Vomiting

This is not a complete list of all possible side effects. Call your doctor for medical advice about side effects.

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.

KRYSTEXXA should be given by a doctor or nurse in a healthcare setting. They will watch you for about 1 hour after the infusion for serious allergic reactions to the infusion and provide treatment if needed.

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

Gout Flares

Medications that lower your uric acid level can trigger flares when you first start taking them. These are called mobilization flares. They are triggered by the movement of uric acid crystals that loosen from your joints as they dissolve.

Gout flares early in treatment are one of the most common side effects of KRYSTEXXA and can be a sign that KRYSTEXXA is working. If you experience a mobilization flare, don’t stop taking KRYSTEXXA. To help manage uncontrolled gout, it’s important to receive KRYSTEXXA every 2 weeks for 6 to 12 months or for as long as your doctor recommends.* Your doctor may give you other medicines to help reduce your gout flares for the first few months after starting KRYSTEXXA.

Infusion Reactions

Your doctor may prescribe KRYSTEXXA alone or KRYSTEXXA with methotrexate, a medicine that helps your body tolerate KRYSTEXXA and improve the way KRYSTEXXA works. In a patient study, people who received KRYSTEXXA with methotrexate had fewer infusion reactions than those who received KRYSTEXXA alone. Infusion reactions were reported in 4% (4 out of 96 people) who received KRYSTEXXA with methotrexate and in 31% (15 out of 49 people) who received KRYSTEXXA alone.

Do not receive KRYSTEXXA if you:

  • have a rare blood problem called glucose 6-phosphate dehydrogenase (G6PD) deficiency or favism
  • have had a serious allergic reaction to KRYSTEXXA or any of its ingredients.

*Optimal treatment duration has not been established.

Learn more about how KRYSTEXXA works with methotrexate. Read the Medication Guide and talk with your doctor about possible side effects of KRYSTEXXA. If you experience any side effects, tell your doctor right away.
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Understand the treatment process

Several steps are built into the KRYSTEXXA treatment process to help ensure the best results:

A blood test will tell your doctor if you have a genetic condition known as a G6PD deficiency, or favism. If you do, you should not take KRYSTEXXA.
Before you start KRYSTEXXA, your doctor will tell you to stop taking oral urate-lowering medicine. Your doctor may prescribe other medicine to reduce the chance of you having an allergic reaction or to treat potential gout flares. Flares may occur when gout buildup starts to dissolve.
Before each IV treatment, you’ll receive a blood test to make sure you can continue KRYSTEXXA. If after taking KRYSTEXXA your uric acid level is above 6 mg/dL on two consecutive times, you cannot continue treatment.
During and after each IV treatment, you’ll be closely monitored for side effects.

Jen overcame her fear of IV treatment

  • Read transcript

    KRYSTEXXA® (pegloticase) is a prescription medicine for adults who have tried other gout medicines and still have high uric acid and gout symptoms. KRYSTEXXA is not recommended if you have high levels of uric acid without a history of gout.  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. Please listen to the Important Safety Information in this video.

    I first got gout about 3 or 4 years ago, and it just got worse and worse and worse. It got to the point where I was getting gout flares every 3 weeks before I made it to a rheumatologist. Gout flares are intense just bone-crushing pain. I was basically at my wit’s end. None of the medications that I was using were working for me. My doctor told me about KRYSTEXXA or pegloticase. He explained that KRYSTEXXA would work differently from the other medications that I was on. It was an infusion treatment that he thought could help my gout. And at the very end of my appointment he walked me back to the infusion room to see this is not a huge, scary place.  That it would go in and could get rid of the uric acid build-up that I had over the years. 

    Uric acid is not an abnormal thing in somebody’s body. Everybody has uric acid. But in some people, we have a hard time getting rid of it all out of our body, and it can just build up. KRYSTEXXA is a enzyme that’s gonna break that down. And quickly, I mean, within a matter of a day, your uric acid level will come down.  And every time they get their infusion, I am checking that uric acid level and I am wanting to see that that uric acid level is always in what I call the sweet spot…really less than 6.

    My doctor warned me that starting KRYSTEXXA might cause gout flares because it kind of takes your uric acid from a high number, down within hours of treatment. So you can experience a gout flare from that drastic change in uric acid.  He also warned me that you could get an allergic reaction during treatment. So I kind of went into it a little bit nervous, honestly. When I first arrived, they bring you back to the infusion room. The nurse brings you back. And they get you set up in the chair.

    Most of the time if it’s the first infusion, they’re nervous so we will sit down in the infusion room and even though the doctor has explained what the medication is and what it treats, we still go over that, again, just to reassure the patient.   We also go over how long or how often they will need to come. The infusion is every 2 weeks. 

    When you think about 6 months compared to how long you had had gout before, that kind of is what you have to do to get through it. 

    KRYSTEXXA definitely is a tool in my toolbox for patients that need it, that I wouldn’t want to be without. The most rewarding part of my job is the patient stories for sure. 

    KRYSTEXXA really made a difference for me. It brought my uric acid levels down to normal, and I’m able to do things that I love doing. 

    IMPORTANT SAFETY INFORMATION

    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. 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 Full Prescribing Information, including Boxed Warning at KRYSTEXXA.com/PI and discuss with your doctor.

    USE

    KRYSTEXXA® (pegloticase) 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).

KRYSTEXXA
gets results.

Over time, KRYSTEXXA reduces gout buildup.

Gout specialists
are experts.

Gout specialists have experience diagnosing and treating uncontrolled gout.

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 Full Prescribing Information, including Boxed Warning and 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.