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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ADMINISTRATION & DOSING

Instructions for starting patients on KRYSTEXXA with methotrexate

Please see Full Prescribing Information, including Boxed Warning.
Methotrexate may not be appropriate for all patients; in these instances, KRYSTEXXA can be administered alone.
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Administration1

  • KRYSTEXXA should be administered in healthcare settings by healthcare providers prepared to manage anaphylaxis and infusion reactions
  • Patients should be premedicated with antihistamines and corticosteroids
  • Patients should be closely monitored for an appropriate period of time for anaphylaxis after administration of KRYSTEXXA
  • Monitor serum uric acid levels prior to infusions and discontinue treatment if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed
  • The pegloticase admixture should only be administered by intravenous infusion slowly, over no less than 120 minutes via gravity feed, syringe-type pump or infusion pump

The recommended dosing is coadministration of KRYSTEXXA with methotrexate1

Folic acid icon

4 weeks prior to treatment

15 mg oral methotrexate weekly
WITH
1 mg oral folic acid daily
  • Confirm screening results for G6PD deficiency test and if patient is hypersensitive to KRYSTEXXA
  • Measure sUA levels
  • Begin methotrexate and folic acid regimen
  • Stop oral ULTs (1 week prior to first infusion)
Folic acid icon

During treatment with KRYSTEXXA

KRYSTEXXA 8 mg intravenous infusion every 2 weeks*
WITH
15 mg oral methotrexate weekly with 1 mg oral folic acid daily†
  • Measure sUA levels within 48 hours prior to each infusion1,2
  • Start premedications, including antihistamines and corticosteroids
  • Gout flare prophylaxis is recommended for at least 6 months
  • Ensure compliance to methotrexate and folic acid regimen throughout duration of treatment
Best results were seen at 6-12 months1‡
KRYSTEXXA alone may be used in patients for whom methotrexate is contraindicated or not clinically appropriate.
*No dosing adjustments needed with KRYSTEXXA for patients with kidney disease.
†If coadministered with methotrexate and folic acid, this should be maintained throughout treatment with KRYSTEXXA.
†The optimal treatment duration for KRYSTEXXA has not been established.1
G6PD, glucose-6-phosphate dehydrogenase; sUA, serum uric acid; ULT, urate-lowering therapy.

Product information1

KRYSTEXXA is a clear, colorless, sterile 8-mg solution of pegloticase in a single-use vial, expressed as amounts of uricase protein. KRYSTEXXA must be diluted prior to use.

Steps to a successful infusion day

Expand All
  • Check and confirm icon

    Step 1: Check and confirm

    • Prior to the first infusion, confirm the patient has normal G6PD activity from lab tests and has discontinued taking urate-lowering therapies (eg, allopurinol and febuxostat)*
      • Do not administer KRYSTEXXA to patients with G6PD deficiency and/or if the patient is hypersensitive to KRYSTEXXA
    • Remind patients why they are not taking oral urate-lowering therapies and ensure they are taking gout flare prophylaxis
    • Your patients must complete enrollment to access our patient-focused services and resources
    • Prior to each subsequent infusion, confirm sUA level was tested in the last 48 hours. Notify prescribing healthcare provider if sUA level has not been tested or if any preinfusion sUA level is >6 mg/dL, and discontinue therapy, particularly after 2 consecutive preinfusion sUA levels are >6 mg/dL. See the KRYSTEXXA Monitoring Protocol
      • If prescribing KRYSTEXXA with methotrexate therapy, this should be maintained throughout treatment with KRYSTEXXA
    *KRYSTEXXA is contraindicated for patients with G6PD deficiency. G6PD deficiency is an abnormally low level of glucose-6-phosphate dehydrogenase. Patients of African, Mediterranean, and South Asian ancestry have a higher risk of deficiency.1sUA, serum uric acid.
  • Counsel patients icon

    Step 2: Counsel your patients

    • Answer your patient’s questions about treatment including diet changes or limitations and offer a Medication Guide, which provides details about proper use, side effects, and coadministration with methotrexate
    • Describe to the patient how KRYSTEXXA works, including the risk of infusion reactions
    • Remind the patient of support services available to them through Amgen By Your Side once they are enrolled
  • Prepare and infuse icon

    Step 3: Prepare and infuse

    • 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.
      • Administer preinfusion medications per prescribing healthcare provider’s orders
        • IV corticosteroid
        • Antihistamine
        • Oral analgesic
      • Remind the patient that they may experience gout flares, but KRYSTEXXA therapy can be continued regardless of gout flares
      • Visually inspect vial for particulate matter and ensure solution is clear and colorless
      • Using aseptic technique, withdraw 1 mL into a sterile syringe and inject into a 250-mL bag of normal or half-normal saline. Gently mix the bag by inverting several times and discard any unused portion of the remaining product. Do not shake
        • No loading dose recommended or required
        • KRYSTEXXA is a single-dose vial
      • The diluted solution should be used within 4 hours
      • Before administration, allow the diluted solution of KRYSTEXXA to reach room temperature
        • Artificial heating should not be used
        • If not administered immediately, it is recommended that the diluted solution be stored in the refrigerator and away from light
      • Initiate infusion at a rate of 125 mL/h or slower via infusion pump or gravity feed
      • Infuse over no less than 2 hours
    DO NOT ADMINISTER AS INTRAVENOUS PUSH OR BOLUS
    • The sticker on the KRYSTEXXA box is available for use on your patient’s chart, if desired
    • Use your normal protocol to monitor for infusion reactions
      • In the event of an infusion reaction, as clinically indicated, the infusion can be slowed or stopped and restarted at a slower rate
  • Prepare and infuse icon

    Step 4: Postinfusion reminders

    • Observe the patient for approximately 1 hour postinfusion
    • Remind the patient of their next sUA test and KRYSTEXXA infusion appointments along with taking prescribed medications, including methotrexate and folic acid if appropriate
    • KRYSTEXXA should be given every 2 weeks—it is recommended to provide a standing order to the lab to check the patient’s sUA level prior to each infusion

Preinfusion Medications

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

Ready to prepare your patient for the first infusion?

Connect with the KRYSTEXXA team to discuss.
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G6PD deficiency screening

KRYSTEXXA is contraindicated in patients with G6PD deficiency.1,3

Learn About Screening

Monitoring protocol

Preinfusion sUA is a powerful biomarker for predicting infusion reactions.

See Monitoring Protocol

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.
    • Belfield KD, et al. Am J Health-Syst Pharm. 2018;75:97-104.
    • National Center for Advancing Translational Sciences, Genetic and Rare Diseases Information Center. https://rarediseases.info.nih.gov/diseases/6520/glucose-6-phosphate-dehydrogenase-deficiency
    • Minucci A, et al. IUBMB Life. 2009;61:27-34.
    • Frank JE. Am Fam Physician. 2005;72:1277-1282.

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.