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
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
If you have more than 1 gout flare a year or gouty lumps while taking gout pills, your medicine may not be doing enough to lower your uric acid level. You may have uncontrolled gout and need a different treatment.
KRYSTEXXA (kris-TEX-uh)
In a study, 71% of patients (71/100) taking KRYSTEXXA with methotrexate vs 39% of patients (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.
KRYSTEXXA is given by intravenous (IV) infusion every other week for 6 to 12 months or as directed by your doctor to help you take control of uncontrolled gout.*
*Best results were seen after 6 to 12 months of treatment. Optimal treatment duration has not been established.
FDA, Food and Drug Administration
Jen's gout symptoms were so severe, especially in her foot, that she described the feeling as "bone crushing". She tried different oral medicines, but none could reduce the number of symptoms she was having. Then she learned about KRYSTEXXA.
krystexxa is not indicated for pain
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.
Narrator:
When trying to manage chronic gout, a uric acid level of less than 6 milligrams per deciliter is considered the target range.
Jen:
When I started KRYSTEXXA, I was in the 10s, my uric acid level, and when I was on KRYSTEXXA, I was at 0. It went completely down to 0 for my entire KRYSTEXXA treatment, and then it slowly built back up to normal from there. For me, I was at my complete breaking point when I finally said yes to KRYSTEXXA, but I hope that people don't get there, because they don't need to get there. KRYSTEXXA had such a positive impact on my life. I want that for other people.
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).
Having more than 1 flare a year while on oral gout med could mean your gout is uncontrolled.
Learn more about uncontrolled goutWe are committed to helping you pay the lowest amount for KRYSTEXXA. If your doctor prescribes KRYSTEXXA, a Patient Access Liaison (PAL) from Amgen By Your Side can show you possible ways to save.
KRYSTEXXA is the first FDA-approved medication for uncontrolled gout. It is a treatment with demonstrated efficacy that has an established safety profile and has been prescribed to patients for over 15 years. KRYSTEXXA can lower your uric acid level enough in just 24 hours to soon start dissolving visible and nonvisible tophi (gouty lumps).
Your doctor may prescribe KRYSTEXXA along with a medicine called methotrexate to help reduce symptoms caused by uncontrolled gout. Patients who took KRYSTEXXA and methotrexate saw best results at 6 to 12 months.*
*Optimal treatment duration has not been established.
FDA, Food and Drug Administration.
Methotrexate can help KRYSTEXXA work better than it does without it.
See how KRYSTEXXA with methotrexate works71% (71/100) of patients taking KRYSTEXXA with methotrexate vs 39%
(20/52) of patients taking KRYSTEXXA alone kept uric acid levels under control.
Medicine given by IV can cause infusion reactions. Since KRYSTEXXA is given by IV, an infusion reaction is possible. Additional medicines, including methotrexate may be prescribed with KRYSTEXXA to reduce the risk of infusion reactions. A study showed people who took methotrexate with KRYSTEXXA had fewer infusion reactions compared to people taking KRYSTEXXA alone.
4%(4/96) of patients had infusion reactions while taking KRYSTEXXA with methotrexate
31%(15/49) of patients on KRYSTEXXA alone had infusion reactions
Your doctor will watch you for infusion reactions. If needed, your treatment may be adjusted or stopped.
KRYSTEXXA starts lowering your uric acid level enough in just 24 hours to begin dissolving tophi you can see and those you cannot see.
By Month 12 of treatment, 54% (28/52) of patients receiving KRYSTEXXA with methotrexate dissolved at least 1 gouty lump compared to 31% (9/29) of patients on KRYSTEXXA alone.
These patients had gouty lumps at the start of the study.
If you and your doctor decide methotrexate is not right for you, KRYSTEXXA can still be effective even when taken alone.
KRYSTEXXA begins working within 24 hours after the first infusion.
Learn what to expect from KRYSTEXXAKhash’s gout progressed so much that he had flares every week even while being compliant on oral gout medication. After his doctor prescribed KRYSTEXXA, he reached out to Lindsey for support.
Khash:
When I was a young adult, I started noticing some of the characteristics of what later on became gout. Well, as time progressed, I felt like my gout was becoming more and more out of control. I get a phone call from my doctor, and he calls me to discuss gout with me. And I'm like, "Great, I've been dealing with this 25-years-plus."
Khash:
... and said, “Listen, we have this drug to help combat your gout. Are you open to it?" I said, "Yes." He was like, "We'll have a patient access liason get in contact with you to discuss it further with you."
Lindsey:
Once you have the pre-medications in your system, the nurse is going to mix the KRYSTEXXA into an IV fluids bag. She's going to hang that up above your chair, start an IV, and the medication is going to infuse over 2 hours.
Khash:
My Patient Access Liaison, Lindsey, really took the time to explain it all to me.
Lindsey:
But after you get this first dose of KRYSTEXXA, in 2 weeks or 2 days before the next dose of KRYSTEXXA, you're going to go to the lab, you're going to get your blood drawn, and they're going to measure your serum uric acid level. Okay?
Khash:
She went over that KRYSTEXXA was IV therapy. “Initially, while we're combating it in your body, if you see any tophi, if you see anything, know that it's like a glacier. If you notice tophi on your skin, underneath it is 10 years of buildup to lead to that point. Initially, as we're attacking that, it's going to cause more flareups, more inflammation.” I'm like, "That's fine," because I've been dealing with that all these years. But I know that it's because it's a response to us dealing with the problem and getting uric acid and gout and the tophi out of my body. I'm 100% for it.
Khash:
It's a big commitment on my time, but given the severity of it and dealing with what I've had to deal with for 25 years or so, that seems small in comparison. Tomorrow's going to be my first IV therapy, so I'm looking forward to that. And it makes me look forward to the next 30, 40 years without having to deal with the same issues.
Lindsey:
You're going to have a whole team of professional nurses there to be watching you and monitoring you to make sure that you're safe.
Khash:
Excellent.
Lindsey:
Okay?
Narrator:
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.
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 have a rare blood problem called glucose 6-phosphatedehydrogenase (G6PD) deficiency, or favism. Your doctor should test you for G6PD before you start KRYSTEXXA.
KRYSTEXXA is not recommended if you have high levels of uric acid without a history of gout.
Before you receive KRYSTEXXA, tell your doctor if you:
Tell your doctor about all the medicines you take. Do not take any other uric acid–lowering drug, such as allopurinol or febuxostat (Uloric®), while taking KRYSTEXXA.
Prior to your treatment with KRYSTEXXA, your doctor may give you medicine to help reduce your chance of getting a 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.
What are the possible side effects of KRYSTEXXA?
Please review important information section above. The most common side effects in patients taking KRYSTEXXA were gout flare-ups or attacks, allergic reactions, nausea, bruising, sore throat, constipation, chest pain, and vomiting.
This is not a complete list of all possible side effects. Tell your doctor or treatment team if you have any side effect that bothers you or that does not go away.
Please see the Medication Guide and Prescribing Information for more information. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch or call the FDA at 1-800-FDA-1088.
Another patient named Brian knew that an IV treatment would require a time commitment. But uncontrolled gout made him lose out on things he enjoyed. So going to KRYSTEXXA infusion appointments was well worth his time.
Learn about Brian’s treatment journey and how his dedication to therapy helped him find relief from uncontrolled gout.
Managing uncontrolled gout can involve a lot of moving parts. Amgen By Your Side is a patient support program that offers one-on-one support from a PAL who can
Your PAL can partner with you through each step of your treatment. How much you interact is completely up to you.
Learn how Brian’s commitment to therapy helped him get back his everyday.
BRIAN:
Once I completed the treatment cycle, everything went away. All my tophi had completely disappeared.
BRIAN:
Living with uncontrolled gout, it's a challenge. I had this growth. It was the size of a golf ball. My kids, they would call it my sixth toe. You know you gotta kind of hobble and take it easy, take your time. Just to get up to go to the bathroom, it just makes you just a different person.
BRIAN:
The two main things that you'll go through is, you got to have the time commitment. You got to be able to be flexible with your time, so you may have to take time off of work. I’m glad I did it.
BRIAN:
You may have a few gout flares at the beginning, but those may be your last. One of the nurses at the infusion center, she's like, "It's a challenge right now, and you are going through some changes, but be patient and stick with it."
BRIAN:
You've got a big support system. Your Patient Access Liaison is your pal because they do help you to get through this trying time, and you also have mentors who have actually gone through the program. It makes a big difference talking to somebody that's gone through it.
BRIAN:
Imagine where you've been, what you've gone through already, how much this has affected your life. Six months to a year, maybe a little bit longer, it was worth it.
BRIAN:
I've got kids in Ohio, Florida, here. Nowadays, I can hop on a plane and go visit them. I’m glad I stuck with it.
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).
Now that your treatment has started, your PAL can help you to keep moving forward. A PAL can help you by
KRYSTEXXA reduces uric acid levels. When uric acid is lowered, harmful gout buildup dissolves. To achieve the full benefit, KRYSTEXXA must be taken every 2 weeks for 6 to 12 months, or as prescribed by your doctor.*
*Best results were seen after 6 to 12 months of treatment. Optimal treatment duration has not been established.
Friends or loved ones helping you through treatment can access educational resources, including tips, tools, and guidance to help them feel supported.
Explore caregiver resources
The key to controlling gout is to dissolve the buildup of uric acid crystals. That means keeping your uric acid levels low enough, for long enough, to allow those crystals to break down. KRYSTEXXA can be an effective treatment for uncontrolled gout with an established safety profile, supported by 15+ years of clinical use. It has also been shown to work in people with CKD. In patient studies, patients with mild to moderate CKD had similar results to those without kidney disease. Learn more about how kidney disease and gout are connected.
With the help of his PAL, Logan managed to stay on track with his treatment for uncontrolled gout.
LOGAN: I’ve learned that I’m a lot stronger than I thought I would be.
LOGAN: Growing up was a lot of outdoors, a lot of sports with my siblings and it was a lot of camaraderie, it was great. When I was around 8 to 10 was really when I started to see some significant differences. Getting tired really easy was kind of a vague first one as a young child just to start to realize maybe I can’t keep up with everybody else. Another part of it was joint pain, inflammation, and that’s really what kind of ticked off and started everything.
It’s hard to understand when you’re so young, but having my mother that kind of experienced the same thing led the professionals to believe that maybe it was something genetic.
I did receive a diagnosis of renal insufficiency. So, there was things that they would diagnose me with, and maybe misdiagnose, because they didn’t think that a young kid could get gout or renal failure to that degree.
I was probably 16 when I first had experience with uncontrolled gout, and it was severe.
It went from zero to 100 extremely fast, extremely rapidly. My hands, my joints would ache. You cannot put your own socks and shoes on. You can’t get out of bed. You can’t walk. In those adolescent years, it was something that was very difficult for me. I wouldn’t wish it on anyone.
The medicine that I was prescribed as a young adult did not give me the relief that was necessary to keep me active, keep me on my feet, and keep me going. Although I was living with my chronic kidney disease, I knew I had to still take care of my uncontrolled gout.
I think when my nephrologist finally told me that I had uncontrolled gout, it was something that I had to sit down and really understand. At that time, they didn’t see any kids that had the same situation. And so, I was living with gout for about eight years before I found KRYSTEXXA.
KRYSTEXXA was something that maybe I was nervous about, but I was also excited because I’m willing to try. My nephrologist explained it to me as “KRYSTEXXA is an infusable drug that you take once every couple of weeks, and it really helps break down the uric acid in your joints, in your bones.”
It was kind of scary at first but I have a patient access liaison named Karen, and she is phenomenal. She really helped me with making sure I was organized with my appointments, making sure that I was where I needed to be and was truly taken care of behind the scenes. It really felt like I had someone on my team.
It’s huge. Every treatment that I had, I would feel better. I can be a lot more active. I can put on my own socks and shoes.
One of the biggest things is that joint pain, that inflammation, the tophi that comes through your skin has all diminished since starting KRYSTEXXA. I think with my mother, with my fiancée, the support has been astronomical. It’s been incredible.
I was able to join my fiancée in hikes and fishing, and golfing was a huge thing that I missed for a very long time. KRYSTEXXA has really given me the opportunity to keep going and keep putting one foot in front of the other every day.
I mean, truly incredible. So, if you have the opportunity, take it.
True. About 1 in 4 people with moderate to severe kidney disease also has gout.
Learn about CKD and gout
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 Full Prescribing Information, including Boxed Warning and 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® (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.
