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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Starting KRYSTEXXA

Preparing for treatment

Important considerations to review with patients before the first infusion and subsequent infusions1

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  • Step 1: Enroll in Amgen By Your Side

    Initiate your patient’s enrollment in Amgen By Your Side by submitting the Patient Enrollment Form (PEF)
    • Your patients must complete enrollment to access our patient-focused services and resources
    • You receive an initial Summary of Benefits, and your patient receives a Welcome Kit
    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®.
    Begin 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.
    Download Form
    All trademarks appearing herein are the property of their respective owners.

  • Step 2 Identify infusion center

    Identify your patient’s infusion center
    • Identify your patient’s infusion location (office, hospital, infusion center, or at home)
      • KRYSTEXXA is indicated to be administered in a healthcare setting by professionals trained to manage serious allergic reactions.1 Potential use of home infusion must be determined by healthcare professionals’ assessment of individual patient needs
    • Order lab work
      • Baseline serum uric acid (sUA) is typically required
    • Initiate methotrexate with folic acid orally 4 weeks prior to KRYSTEXXA if appropriate
    • Confirm urate-lowering therapies have been discontinued

  • Step 3: Perform preinfusion test

    Infuse1*
    • Perform preinfusion sUA test, preferably within 48 hours prior to each infusion (with exception of the first infusion)1,2†
    • Patient should take prescribed medications, including methotrexate and folic acid when appropriate
    Infusion1
    • 2-hour infusion (minimum)
    • Closely monitor for anaphylaxis for an hour after administration of KRYSTEXXA
    *KRYSTEXXA is available through Amgen-authorized specialty distribution partners.
    †sUA is a predictive biomarker for infusion reactions, risk, and product efficacy.

Preinfusion Medications

See which medications your patients should take prior to infusing KRYSTEXXA.
Download Guide

Ready to start infusing KRYSTEXXA?

Connect with the KRYSTEXXA team to discuss initiating treatment.

Request Support

Administration & dosing

There are several steps to prepare KRYSTEXXA for infusion and ensure the prescribed dose is administered.

Get Dosing Instructions

Learn more about patients who might benefit from KRYSTEXXA

Actor portrayal of patient with no visible tophi

Michelle

Occupation:
Nurse

59-year-old with no visible tophi, but has pain and tenderness in her hands; diagnosed with gout 5 years ago

Actor portrayal, not actual patient.

Learn About Michelle
Actor portrayal of patient with pain who was diagnosed with gout years ago

Andrew

Occupation:
Real estate agent

56-year-old with hypertension and pain in hands and feet; diagnosed with gout 8 years ago

Actor portrayal, not actual patient.

Learn About Andrew
Real KRYSTEXXA patient, Bet

Bet

Occupation:
Stay-at-home parent

43-year-old diagnosed with gout over 20 years ago

Real patient.

Learn About Bet

KRYSTEXXA is not indicated for the treatment of pain.

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
    • KRYSTEXXA (pegloticase) [prescribing information] Horizon.
    • Keenan RT, et al. Rheumatol Ther. 2019;6:299-304.

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.