For Patients and Caregivers For Healthcare Professionals Full Prescribing Information Important Safety Information Medication Guide KRYSTEXXA.com

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WHAT TO EXPECT

Preparing for Your KRYSTEXXA® (Pegloticase) Treatment Experience

Your PAL is your dedicated point of contact, ready to partner with you to support your unique KRYSTEXXA® (pegloticase) treatment experience. They will help you understand what to expect with your new treatment, how to fit your new treatment into your routine, and how to get ready for your next doctor's visit.

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Watch a real patient prepare for her KRYSTEXXA® (Pegloticase) treatment experience
  • Read Transcript

    Speaker 1:
    KRYSTEXXA 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.
    Jennifer:
    I first got gout about three or four years ago, and it just got worse and worse and worse. It got to the point where I was getting gout every three weeks before I made it to a rheumatologist. Gout flares are intense just bone-crushing pain. I was basically at my wit's end. None of the medications that I was using were working for me.
    Jennifer:
    My doctor told me about KRYSTEXXA or pegloticase. He explained that KRYSTEXXA would work differently from the other medications that I was on. It was an infusion treatment that he thought could help my gout flares. And at the very end of my appointment he walked me back to the infusion room to see this is not a huge, scary place. That it would go in and could get rid of all the uric acid build-up I had over the years.
    Dr. Christopher Parker:
    Uric acid is not an abnormal thing in somebody's body. Everybody has uric acid. But in some people, we have a hard time getting rid of it all out of our body, and it can just build up. KRYSTEXXA is an enzyme that's going to break that down. And quickly, I mean, within a matter of a day, your uric acid level will come down. And every time they get their infusion, I am checking that uric acid level and I am wanting to see that that uric acid level is always in what I call the sweet spot…really less than 6.
    Jennifer:
    My doctor warned me that starting KRYSTEXXA might cause gout flares because it takes your uric acid from a high number, 9 or 10, typically, down to 0 overnight, or within 6 hours of treatment. So you can experience a gout flare from that drastic change in uric acid. He also warned me that you could get an allergic reaction during treatment. So kinda went into a little bit nervous, honestly.
    Jennifer:
    When I first arrived, they bring you back to the infusion room. The nurse brings you back. And they get you set up in the chair.
    Jasmine Kershaw:
    Most of the time, if it's the first infusion, they're nervous so we will sit down in the infusion room and even though the doctor has explained what the medication is and what it treats, we still go over that again, just to reassure the patient.
    Jasmine Kershaw:
    We also go over how long or how often they will need to come. The typical infusion is every 2 weeks and it can vary between 6 to 8 months for the length of time.
    Jennifer:
    When you think about 6 months compared to how long you had had gout before, that kind of is what you have to do to get through it.
    Dr. Christopher Parker:
    KRYSTEXXA definitely is a tool in my toolbox for patients that need it, that I wouldn't want to be without. The most rewarding part of my job is the patient stories for sure.
    Jennifer:
    KRYSTEXXA really made a difference for me. It brought my uric acid levels down to normal, and I'm able to do things that I love doing, like getting my life back pretty much.

    Speaker 1:

    INDICATION AND 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 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.

Read Transcript 

CATHERINE VO:

My name is Catherine, and I’ve been living with uncontrolled gout. I’ve become a Peer Mentor where I can share my story with other people.

SUPER:

CATHERINE KRYSTEXXA Peer Mentor

KRYSTEXXA is FDA-approved for adults. KRYSTEXXA is not indicated to relieve pain. Individual results may vary.

Please listen to Important Safety Information at the end of this video.

CATHERINE VO:

I started using a cane because my walk became unsteady. I had a hard time writing, gripping things, standing.

SUPER:

Catherine’s video about being a peer mentor will begin shortly.

KRYSTEXXA® (pegloticase) is a prescription medicine for adults who have tried other gout medicines and still have high uric acid levels and gout symptoms. KRYSTEXXA is not recommended if you have a high level of uric acid without a history of gout.

CATHERINE VO:

When my rheumatologist diagnosed me with uncontrolled gout. I’d never heard of it before.

SUPER:

KRYSTEXXA is FDA-approved for adults with uncontrolled gout. Individual results may vary.

CATHERINE VO:

He said you have uncontrolled gout because the medication I had prescribed you is not effective.

SUPER:

KRYSTEXXA is FDA-approved for adults with uncontrolled gout. Individual results may vary.

SUPER:

Catherine was initially diagnosed with gout.

Despite treatment with oral urate-lowering therapies, it later became uncontrolled.

CATHERINE VO:

Once I was prescribed KRYSTEXXA, I realized there was hope for me.

SUPER:

To help support other people diagnosed with uncontrolled gout, Catherine became a KRYSTEXXA Peer Mentor.

CATHERINE VO:

The Peer Mentor Program is a way to communicate patient-to-patient: Just everyday people that need help with uncontrolled gout.

CATHERINE VO:

Peer Mentors are available for patients before they start KRYSTEXXA, and they can also contact Peer Mentors after any appointment that they have.

SUPER:

You or your loved one must have a prescription for KRYSTEXXA in order to speak with a Peer Mentor.

CATHERINE VO:

They may have questions and want more information and peace of mind.

SUPER:

Gout flares may increase in the first 3 months when you start receiving KRYSTEXXA.

CATHERINE VO:

I’ve spoke to quite a few people across the United States and different stages of uncontrolled gout. But they all had the same concern: Will KRYSTEXXA help me?

SUPER:

Will KRYSTEXXA help me?

CATHERINE VO:

The more I talked about having uncontrolled gout, the more I wanted to help other people and to share my story.

CATHERINE VO:

I had a woman contact me...her doctor didn’t have a lot of time to spend with her. She couldn’t understand the vocabulary words, the symptoms... and left the doctor’s office with more questions.

She told me that she was about ready to give up. By the end of the conversation, she had hope that KRYSTEXXA was going to help her.

CATHERINE VO:

It helps talking to a Peer Mentor because they’re going through the same thing you are.

Most of it’s sadness and confusion, and I answer any questions that they have and give them some hope.

That’s how I humanize KRYSTEXXA: I put a voice with it.

CATHERINE VO:

How a patient can access the Peer Mentor Program, you can go on the website of KRYSTEXXA, and they will put you in contact with a person, and you can get your questions answered.

SUPER:

Click to request a Peer Mentor

You or your loved one must have a prescription for KRYSTEXXA in order to speak with a Peer Mentor.

CATHERINE VO:

I hope that our Peer Mentor Program expands the knowledge that they have somebody that can listen to them and explain in day-to-day language where there’s some hope and help for them with their gout.

SUPER:

Click to request a Peer Mentor

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 Full Prescribing Information, including Boxed Warning at Krystexxa.com/PI 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).

Listen to learn more about our Peer Mentor program

Learn How to Take Advantage of One-on-One Peer Mentor Conversations—Real Patients You Can Talk With

Our peer mentors will tell you what KRYSTEXXA has been like for them. They volunteer because they want to help others the same way they’ve been helped.

Take a closer look at the KRYSTEXXA treatment timeline at KRYSTEXXA.com

Find out where you can receive KRYSTEXXA treatment

Learn about keeping track of your progress and completing your KRYSTEXXA treatment

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 Full Prescribing Information, including Boxed Warning 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).

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 Guideand Full Prescribing Information, including Boxed Warning 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).