Hi there, if you’re watching this video, that means your doctor has determined that you’re gout has become out of
control. Gout is a serious disease that can cause chronic swelling, pain and stiffness in the joints. In fact,
its actually a form of arthritis. And even when you aren’t feeling pain Gout is still there. If you have gout
you have too much uric acid in your body.
This means you may have needle like uric acid crystals building up almost anywhere in your body, in your joints
and bones, even in your vital organs like your heart or kidneys. These uric acid crystals, sometimes just called
crystals can form visible and non-visible lumps throughout your body that can cause permanent damage. When it
comes to gout most people think of painful flares, but that’s not the whole story. Once a flare ends gout
doesn’t go away. If you’re uric acid level stays too high despite treatment crystals keep building up and your
gout may become out of control. Doctors refer to this as uncontrolled gout. Without proper treatment you’re at
risk for bone erosion and permanent joint damage. So how can you tell if your gout is out of control? Simple
your daily oral gout medicines aren’t working well enough. First off they’re not getting your uric acid level as
low as it needs to be and secondly, you’re still having symptoms like more than one flare in the last 12 months
or have lumps of uric acid crystals under your skin called tophi. Finding out your uric acid level is easy. Your
doctor can do a blood test. This can help your doctor determine if your gout is out of control. To dissolve uric
acid crystals your uric acid level has to be 6 milligrams per deciliter or lower. This is called the dissolve
zone the lower you get into the dissolve zone the faster crystal buildup will dissolve. Taking daily gout pills
doesn’t guarantee you will get into the dissolve zone.
In fact, that only happens about half the time depending on the medication. If your level is higher than 6
milligrams per deciliter, you’re in the buildup zone meaning crystals can’t dissolve but continue to buildup
this could put you at risk for long-term joint damage and bone erosion. Are you considering all of your options?
Krystexxa is a treatment for people who have tried gout pills like Allopurinol or Urolic at maximum medically
appropriate doses, but their gout has become out of control. Gout pills can take more than two years to dissolve
even a small marble sized amount of crystal buildup, but with Krystexxa, you could get rid of years of gout
buildup in months.
So what makes Krystexxa different? Krystexxa changes uric acid into a water-soluble substance that your body can
easily get rid of through urine. This lowers your uric acid level allowing your crystal buildup to dissolve, if
appropriate your doctor may prescribe Krystexxa together with a medicine called Methotrexate. In a clinical
study 7 out of 10 people taking Krystexxa with Methotrexate got their uric acid level into the dissolve zone and
kept it there for the majority of their time on treatment. In fact all patients who tried Krystexxa were able to
get into the dissolve zone within 24 hours of their first treatment. But even though they got into the dissolve
zone right away, taking Krystexxa for at least six months is what kept them there. And while their crystal
buildup developed over several years as their gout got out of control, Krystexxa helped these patients dissolve
their crystal buildup in a matter of months. In a clinical study more than half of people given Krystexxa with
Methotrexate saw complete elimination of at least one lump of uric acid or tophus after 12 months and no new
lumps formed during treatment.
But what about the crystal buildup that isn’t noticeable on the outside of your body? Krystexxa can dissolve both
visible and non-visible uric acid crystals, so it can even dissolve the crystal buildup that you can’t see.
Before your first treatment your doctor may check your baseline uric acid level with a blood test. You’ll get
your level rechecked a day or two before each treatment with Krystexxa. Monitoring your uric acid level helps
you and your doctor see if Krystexxa is working for you and predict your risk of an infusion reaction. Here’s
how it works, while on Krystexxa if you're uric acid level is in the dissolve zone that means Krystexxa is
working and dissolving crystal buildup. So your body can get rid of it. If you’re uric acid level goes up into the buildup zone while on
Krystexxa above six milligrams per deciliter, your body is fighting against Krystexxa. When this happens Krystexxa stops working
and your risk of an infusion reaction goes up. To avoid a reaction your doctor may have you stop treatment. In a
clinical study very few patients had a severe infusion reaction called anaphylaxis.
Those reactions were resolved with stopping or slowing Krystexxa and most were treated with common medications
such as Benadryl. The most common side effects in patients taking Krystexxa plus Methotrexate were gout flares, joint
pain, coronavirus disease 2019, covid-19, nausea and fatigue. Krystexxa, like other medicines that lower uric
acid can cause gout flares when first starting treatment that's because any time your uric
acid level goes up or down quickly, it can trigger a flare. This is why you sometimes get a flare after eating
certain foods or being dehydrated from travel because Krystexxa lowers their uric acid levels. Some patients
experience increased flares when treatment begins. These flares can actually be a sign that Krystexxa is
working. Your doctor can give you medicine to treat these kinds of flares and in clinical studies most Krystexxa
patients had fewer flares as treatment continued. Hey Paul, do you want to tell us a little bit about your
experience with Krystexxa? Sure, you know, I had heard that Krystexxa might cause more flares in the beginning, but I've been dealing with that
all these years without actually helping the problem. Now if I have to deal with flares for a temporary amount of time, but I
know that it's because we're dealing with the problem. I'm 100% forward. Krystexxa goes directly into your bloodstream through
a needle that’s placed in your arm this is called an IV treatment. You'll receive krystexxa every two weeks and the
treatment itself takes about two hours. When you're receiving Krystexxa, you're free to read, use your laptop, take a nap or watch
a movie. I got approved to be on the IV drug and it scared me. I kept waiting for something to happen. But
after about the third IV, I was comfortable enough to go and just have it as a routine. Krystexxa isn't a
medicine you'll take for the rest of your life. It's a short-term treatment that can help you regain control of
your Gout. We want to ensure you feel supported throughout your treatment with Krystexxa. This is where a patient access
liaison comes in. Here's one of our patient access Liaisons, Jill.
Hi, there. I'm available to help you throughout your whole experience with Krystexxa. I want to make sure you find answers to your questions and that you feel supported every step of the
way. I can also connect you with our peer mentor program, a group of real patients who can tell you all about their
experiences with Krystexxa. See, they're pretty excited to meet you. When it comes to gout that is out of
control, it can get worse the longer you wait. To lower your risk of future flares and prevent permanent joint
damage and bone erosion. You need to dissolve your crystal buildup. Krystexxa can help you get rid of crystal
buildup by getting you into the dissolve zone quickly. Feel free to watch this video again reviewing any chapters that
interest you and share it with your friends or family. When you
start Krystexxa, you're one step closer to regaining control of your gout and taking back your everyday.
Important safety information. 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. 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 two 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've 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 three 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
three 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.