Please ensure JavaScript is enabled for purposes of website accessibility Side Effects | KRYSTEXXA® (pegloticase)

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

Medicines that lower uric acid levels, including KRYSTEXXA, may cause side effects

KRYSTEXXA could help you finally take control of uncontrolled gout. In just 24 hours, KRYSTEXXA can lower your uric acid level enough to begin dissolving years of gout buildup. In a study, 71% (71/100) taking KRYSTEXXA with methotrexate vs 39% (20/52) taking KRYSTEXXA alone kept uric acid levels under control at Month 6. Gouty lumps were reduced in 54% of patients (28/52) taking KRYSTEXXA with methotrexate vs 31% of patients (9/29) taking KRYSTEXXA alone at month 12.

Clinical trials have demonstrated KRYSTEXXA efficacy and have established a safety profile including kidney disease patients with uncontrolled gout. Many people with kidney disease also have gout. 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.

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

All 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 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.

The study also showed that more gouty lumps were dissolved in patients who took KRYSTEXXA with methotrexate than those who took KRYSTEXXA alone. If you and your doctor decide methotrexate is not right for you, KRYSTEXXA can be effective even when taken alone. 

*Optimal treatment duration has not been established.

Learn more about how KRYSTEXXA works with methotrexate.
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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

    Narrator:

    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.

    Jen:

    The gout pain was severe. It is unlike anything else I'd ever experienced, and it's literally like a band is just wrapped around your entire foot and is just tightening and tightening and tightening, and it feels like it's bone crushing. This pain impacted my life because just moving around is intense pain and you can't do anything. When nothing was working, I was really thinking, "This is my life. We know what it is, and I've been given medication for it, and it's not working, so what else is there to do at that point?” I was terrified. I can't live like this. I was kind of like, "Okay, I'll go see a new doctor, and he's a gout specialist. That's great. Maybe he can tell me a little bit more." He did mention KRYSTEXXA. This is an infusion drug, and it's a big-time commitment.

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.