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

The recommended dosing is coadministration of 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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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.

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 gout and CKD patient, Richard

Richard, CKD stage 4

Occupation:
Bus driver

52-year-old with CKD stage 4; 3 flares in the last year and no visible tophi

Actor portrayal, not actual patient.

Learn About Richard
Actor portrayal of gout and CKD Stage 3b patient, Susan

Susan, CKD stage 3b

Occupation:
Dental hygienist

45-year-old with CKD stage 3b; 3 flares in the last year and 1 small tophus on her left hand for the past 2 years

Actor portrayal, not actual patient.

Learn About Susan
Real KRYSTEXXA patient, Michael, with a 30-year history of gout

Michael, CKD stage 3b

Occupation:
Architect

60-year-old diagnosed with gout over 30 years ago

Real patient.

Learn About Michael

CKD, chronic kidney disease.

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
    1. KRYSTEXXA (pegloticase) [prescribing information] Horizon.
    2. FitzGerald JD, et al. Arthritis Care Res (Hoboken). 2020;72:744-760.

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.