Key Inclusion/Exclusion Criteria3

Inclusion

  • Adult patients ≥18 years old with diagnosis of gout
  • Uncontrolled gout, defined as (all required)
    • Serum uric acid (sUA) ≥7 mg/dL
    • Oral urate lowering therapy failure/intolerance
    • ≥1 ongoing gout symptom (≥1 tophus, ≥2 flares in the year prior to screening and/or chronic gouty arthritis)

Exclusion

  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • eGFR <40 mL/min/1.73 m2
  • MTX contraindication/known intolerance
  • Elevated LFTs, low albumin or low blood cell counts
eGFR, estimated glomerular filtration rate; LFTs, liver function tests; MTX, methotrexate.

Family history, health literacy, and socioeconomic environment are contributing factors to gout becoming uncontrolled18,19

Two major factors contribute to uric acid buildup and crystallization18,19

Genetics
Gout runs in the family
Kidney damage
Impaired uric acid elimination
Additional contributing factors include4,18,20,21:
  • Diet and lifestyle
  • Age
  • Comorbidities
  • Metabolism
Diet is not a substitute for treatment as dietary restrictions may reduce uric acid levels by only ~1 mg/dL13,22

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HELPFUL RESOURCES

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Getting started

Encourage patients to view the video about uncontrolled gout and KRYSTEXXA at YourGoutTreatment.com.
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AMGEN By Your Side logo
Amgen By Your Side is a support program for patients prescribed KRYSTEXXA. Once the enrollment process is complete, they will be paired with their own dedicated support partner, called a Patient Access Liaison (PAL). Their PAL can be a partner, providing nonmedical education to help them navigate their unique treatment experience—including information on insurance, financial assistance options, important appointment-related information, and other patient support services.

Connect your patients to nonmedical, logistical support

Learn about the dedicated Amgen By Your Side team

Download forms and clinical resources

Reimbursement

Patient Enrollment Form

Once you decide KRYSTEXXA is right for your patient, you can start their enrollment in Amgen By Your Side with the Patient Enrollment Form (PEF) and submit it using one of the options listed below. Patient consent will be required.

Option 1: Online Submission

Fill out the form, sign, and submit online through DocuSign®.

Start Here

Option 2: Offline Submission

Fill out the form, then download, sign, and fax the form to 877-633-9522 OR email it to GOUTABYS@amgen.com.

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Enrollment Form Guide Download Form - Spanish
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Common Patient Questions

Patients often have questions. Below are answers to help support your conversations.

KRYSTEXXA + KIDNEY DISEASE
KRYSTEXXA + KIDNEY DISEASE
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  • Will taking KRYSTEXXA impact my chronic kidney disease (CKD)?

    KRYSTEXXA was studied in patients with chronic kidney disease. Your doctor doesn’t have to change the way KRYSTEXXA is prescribed to you based on your CKD.

  • Will KRYSTEXXA affect my eGFR?

    In clinical trials, patients with chronic kidney disease taking KRYSTEXXA did not see any change in their estimated glomerular filtration rate.1

    KRYSTEXXA has not been studied to reverse damage to the kidneys. Change in eGFR was not a pre-specified endpoint of the MIRROR trial and not powered to detect change in renal function.

  • When do I screen my patients?

    Once you decide KRYSTEXXA is right for your patient, you can start their enrollment in Amgen By Your Side with the Patient Enrollment Form (PEF) and submit it using one of the options listed below. Patient consent will be required.

  • Will my chronic kidney disease make KRYSTEXXA less effective?

    People with kidney disease saw similar reductions in their uric acid levels compared to people without kidney disease.1,2

MECHANISM OF ACTION + SCHEDULE
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  • How does KRYSTEXXA work?

    KRYSTEXXA works to change uric acid into a water-soluble substance that can easily be eliminated by the kidneys through urine.2

  • Why can’t I take KRYSTEXXA as a pill?

    KRYSTEXXA is a delicate enzyme that would be destroyed in your stomach if taken as a pill.2

  • Do I have to get KRYSTEXXA infused every 2 weeks?

    Yes. The recommended dosing schedule is KRYSTEXXA every 2 weeks in combination with oral methotrexate (15 mg) once weekly and folic acid (1 mg) daily throughout treatment.2

    KRYSTEXXA can also be taken without methotrexate if your doctor does not think it’s right for you.

  • What happens if I miss an infusion?

    Making time for your infusions can be challenging, but in order to see the best results with KRYSTEXXA, it’s important to receive your infusion every 2 weeks. If you are going to miss an appointment, contact your doctor or infusion center as soon as possible to reschedule.2

  • When will I start seeing results with KRYSTEXXA?

    KRYSTEXXA starts working within 24 hours. In clinical studies, best results were seen at 6-12 months of treatment.2,3 The optimal treatment duration with KRYSTEXXA has not been established.

  • What happens after I finish taking KRYSTEXXA?

    You and your doctor will decide on a plan to keep urate crystals from building up again.2
FLARES, REACTIONS + SIDE EFFECTS
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  • Could I still have flares after starting KRYSTEXXA?

    Yes, gout flares are common even when the treatment is working. KRYSTEXXA rapidly reduces the uric acid level in the blood, allowing urate crystals to dissolve.2 As crystal deposits break down and leave the body, flares can occur, including in areas where patients haven’t previously had a flare. This may be alleviated or prevented by taking anti-inflammatory medication. Most people in the clinical trials said they were having fewer flares by the end of treatment.4

  • Do I still take my other gout medicine(s) with KRYSTEXXA?

    While taking KRYSTEXXA, do not take any other uric acid-lowering drug, such as allopurinol or febuxostat (Uloric). Your doctor may give you medicine (colchicine and/or NSAIDs) to help with gout flares you may have while on KRYSTEXXA. In preparation for your KRYSTEXXA infusion, your doctor may also give you antihistamines and corticosteroids.2

  • What are the most common side effects?

    In the clinical trial, the most common side effects in people taking KRYSTEXXA with methotrexate (≥5% of patients) were gout flares, joint pain, COVID-19, nausea, and fatigue. The most common side effects in people taking KRYSTEXXA alone were gout flares, infusion reactions, nausea, contusion or ecchymosis, nasopharyngitis, constipation, chest pain, anaphylaxis, 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.2

  • What happens if I have an allergic reaction?

    You’ll receive KRYSTEXXA in a healthcare setting where a doctor or nurse will watch you for any side effects or allergic reactions. If you have any side effects, your doctor may stop or slow the infusion and may give you medicine. You should seek medical care immediately if you experience any symptoms of an allergic reaction during or at any time after the infusion of KRYSTEXXA.2

  • Can I continue taking KRYSTEXXA if I have an infusion reaction?

    It depends. Based on the doctor’s assessment, the infusion may be slowed or stopped and restarted when the reaction is resolved. It is also possible that treatment may not be restarted.2
eGFR, estimated glomerular filtration rate; MIRROR, Methotrexate to Increase Response Rates in Patients with Uncontrolled Gout Receiving Pegloticase.

Downloadable Resources

Review and download essential resources for KRYSTEXXA administration.

G6PD Deficiency
KRYSTEXXA is contraindicated in patients with G6PD deficiency.
Download Guide
Preinfusion Medications
See which medications patients should take prior to infusing KRYSTEXXA.
Download Guide
Dosing and Administration
Review instructions for starting patients on KRYSTEXXA.
Download Guide
Adverse Reaction Management
See how the addition of methotrexate reduces infusion reactions.
See the Data
Infusion Checklist
Review key steps to prepare patients for proper administration and infusion.
Download Checklist
Postinfusion
See how to monitor patients after infusion and next steps.
Download Guide
Important Contact Information
Get contact information for specialty and wholesale distributors of KRYSTEXXA.
Download Guide
Amgen By Your Side Overview
Connect your patients to nonmedical logistical support once prescribed KRYSTEXXA.
Download Overview
Talking to Your Employer
Help your patients build their support system, which may include their employer.
Download Guide

IMPORTANT SAFETY INFORMATION

WARNING: ANAPHYLAXIS AND INFUSION REACTIONS, G6PD DEFICIENCY ASSOCIATED HEMOLYSIS AND METHEMOGLOBINEMIA

  • Anaphylaxis and infusion reactions have been reported to occur during and after administration of KRYSTEXXA.
  • Anaphylaxis may occur with any infusion, including a first infusion, and generally manifests within 2 hours of the infusion. Delayed hypersensitivity reactions have also been reported.
  • KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions.
  • Premedicate with antihistamines and corticosteroids and closely monitor for anaphylaxis for an appropriate period after administration of KRYSTEXXA.
  • Monitor serum uric acid levels prior to each infusion and discontinue treatment if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed.
  • Screen patients at risk for glucose-6-phosphate dehydrogenase (G6PD) deficiency prior to starting KRYSTEXXA. Hemolysis and methemoglobinemia have been reported with KRYSTEXXA in patients with G6PD deficiency. KRYSTEXXA is contraindicated in patients with G6PD deficiency.

CONTRAINDICATIONS:

  • In patients with G6PD deficiency.
  • In patients with history of serious hypersensitivity reactions, including anaphylaxis, to KRYSTEXXA or any of its components.

WARNINGS AND PRECAUTIONS

Gout Flares: An increase in gout flares is frequently observed upon initiation of anti-hyperuricemic therapy, including KRYSTEXXA. Gout flare prophylaxis with a non-steroidal anti-inflammatory drug (NSAID) or colchicine is recommended starting at least 1 week before initiation of KRYSTEXXA therapy and lasting at least 6 months, unless medically contraindicated or not tolerated.

Congestive Heart Failure: KRYSTEXXA has not been formally studied in patients with congestive heart failure, but some patients in the pre-marketing placebo-controlled clinical trials experienced exacerbation. Exercise caution in patients who have congestive heart failure and monitor patients closely following infusion.

ADVERSE REACTIONS

The most commonly reported adverse reactions (≥5%) are:

KRYSTEXXA co-administration with methotrexate trial:

KRYSTEXXA with methotrexate: gout flares, arthralgia, COVID-19, nausea, and fatigue; KRYSTEXXA alone: gout flares, arthralgia, COVID-19, nausea, fatigue, infusion reaction, pain in extremity, hypertension, and vomiting.

KRYSTEXXA pre-marketing placebo-controlled trials:

gout flares, infusion reactions, nausea, contusion or ecchymosis, nasopharyngitis, constipation, chest pain, anaphylaxis, and vomiting.

INDICATION

KRYSTEXXA® (pegloticase) is indicated for the treatment of chronic gout in adult patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated.

Limitations of Use: KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.

Please see Full Prescribing Information, including Boxed Warning.

  • References
    • Yood RA, et al. BMC Res Notes. 2014;7:54.
    • KRYSTEXXA (pegloticase) [prescribing information] Horizon.
    • Sundy JS, et al. JAMA. 2011;306:711-720.
    • Boston JK, et al. ACR Open Rheumatol. 2023;5:407-418.

IMPORTANT SAFETY INFORMATION

WARNING: ANAPHYLAXIS AND INFUSION REACTIONS, G6PD DEFICIENCY ASSOCIATED HEMOLYSIS AND METHEMOGLOBINEMIA

  • Anaphylaxis and infusion reactions have been reported to occur during and after administration of KRYSTEXXA.
  • Anaphylaxis may occur with any infusion, including a first infusion, and generally manifests within 2 hours of the infusion. Delayed hypersensitivity reactions have also been reported.
  • KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions.