A Different Kind of Uric Acid Treatment | KRYSTEXXA® (pegloticase)

KRYSTEXXA is approved to be given with methotrexate

Methotrexate can help KRYSTEXXA work better than it did before.

Narrator:

Exciting news! KRYSTEXXA is the only FDA-approved treatment for out-of-control gout, and it’s approved to be given with methotrexate.

Methotrexate helps KRYSTEXXA work better than it did before. Your doctor may prescribe KRYSTEXXA with methotrexate to reduce symptoms caused by out-of-control gout.

KRYSTEXXA with methotrexate can significantly lower your uric acid level in 24 hours after the first IV treatment and help keep it there.

At Month 6 in a clinical study, 71% of people receiving KRYSTEXXA with methotrexate kept their uric acid levels below 6 mg/dL, which is low enough to dissolve gout buildup, compared with 39% of people on KRYSTEXXA alone.

At Month 12 in a clinical study, 31% of people receiving KRYSTEXXA alone dissolved at least 1 tophus, or gouty lump, compared with 54% of people receiving KRYSTEXXA with methotrexate.

KRYSTEXXA with methotrexate reduces the risk of infusion reactions. Studies reveal infusion reactions were less common when KRYSTEXXA was taken with methotrexate.

At Month 6 in a clinical study, 31% of people on KRYSTEXXA alone had infusion reactions, while only 4% of people had infusion reactions while taking KRYSTEXXA with methotrexate.

KRYSTEXXA should be given to you by a doctor or nurse in a healthcare setting where serious allergic reactions can be treated.

Lowering your uric acid level enough to dissolve gout buildup is the key to reducing the impact of out-of-control gout.

Clinical studies revealed that in about 6 months, KRYSTEXXA with methotrexate can remove years of uric acid crystal buildup from your joints.

The best results for patients on KRYSTEXXA with methotrexate were seen in 6 to 12 months.

If you and your doctor decide methotrexate is not right for you, KRYSTEXXA is effective when taken alone.

It’s important to connect with a gout specialist to determine if KRYSTEXXA with methotrexate is right for you.

Find a gout specialist in your area by entering your ZIP code in the search bar.

Narrator:

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 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).

Enter your ZIP Code below to find a specialist.

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If you have flares even while taking oral gout medicine, it is important to tell a doctor. A gout specialist is a doctor who has experience treating uncontrolled gout. Find a gout specialist who can help you decide if KRYSTEXXA is right for you.

Uric acid buildup can happen almost anywhere in the body

Illustration representing complications of gout in feet, spine, and other parts of the body

Uncontrolled gout can impact more than the joints.
Buildup of uric acid crystal caused by gout can deposit in places that you can't see

Oral gout medicines don’t:

Convert uric acid

KRYSTEXXA is the only gout treatment that controls chronic gout by changing uric acid into a water-soluble substance called allantoin that your body easily gets rid of through urine.

Significantly lower your uric acid level in 24 hours

After just 1 IV treatment, KRYSTEXXA starts to lower your uric acid level enough to begin dissolving years of uric acid crystal buildup.

Dissolve years of gout buildup in just months

It can take more than 2 years for oral gout medicines to dissolve even a small amount of uric acid crystal buildup. KRYSTEXXA can dissolve most of it in 6 to 12 months or for as long as your doctor recommends.^*

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

KRYSTEXXA is approved to be given with methotrexate

Your doctor may prescribe KRYSTEXXA with a medication called methotrexate to reduce symptoms caused by uncontrolled gout. KRYSTEXXA lowers uric acid levels in the blood as soon as 24 hours after the first IV treatment. Patients saw best results at 6 to 12 months^† on KRYSTEXXA along with methotrexate. Patients who used KRYSTEXXA along with methotrexate had fewer infusion reactions and more reductions in tophi, or gouty lumps.

^†Optimal treatment duration has not been established.

At Month 6 of a clinical study

71% of people on KRYSTEXXA along with methotrexate kept their uric acid levels below 6 mg/dL

39% of people on KRYSTEXXA alone
kept their uric acid levels below 6 mg/dL

Infusion reactions

KRYSTEXXA is an infused medication and can cause infusion reactions, which can be severe. In the clinical study, people who took KRYSTEXXA with methotrexate were less likely to experience infusion reactions.

4% of people had infusion
reactions while taking
KRYSTEXXA with methotrexate

31% of people on KRYSTEXXA alone
had infusion reactions

Your doctor will monitor you for reactions, and if needed, will adjust your medication dosage.

Results for people with tophi, or gouty lumps

KRYSTEXXA lowers your uric acid level enough in just 24 hours to start dissolving visible and nonvisible tophi.

54%

of people receiving KRYSTEXXA with methotrexate dissolved at least 1 tophus, or gouty lump, by Month 12 of treatment compared with 31% of those who took KRYSTEXXA alone.

If you and your doctor decide methotrexate is not right for you, KRYSTEXXA is effective when taken alone.

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.

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.

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.

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.

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.

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.

What are the possible side effects of KRYSTEXXA?

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).

KRYSTEXXA works differently than oral gout treatments

KRYSTEXXA is approved to be given with methotrexate

Enter your ZIP Code below to find a specialist.

Uric acid buildup can happen almost anywhere in the body

Oral gout medicines don’t:

KRYSTEXXA is approved to be given with methotrexate

At Month 6 of a clinical study

Infusion reactions

Results for people with tophi, or gouty lumps

USE AND IMPORTANT SAFETY INFORMATION

USE AND IMPORTANT SAFETY INFORMATION

USE

USE AND IMPORTANT SAFETY INFORMATION

USE AND IMPORTANT SAFETY INFORMATION

USE