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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:
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 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).
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.
KRYSTEXXA has not been studied to reverse damage to the heart, kidneys, or any of the body’s organs.
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.
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.
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
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.
KRYSTEXXA lowers your uric acid level enough in just 24 hours to soon 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. These results were among patients who had tophi at baseline.
If you and your doctor decide methotrexate is not right for you, KRYSTEXXA is effective when taken alone.
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 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?
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.