Urate Deposition in Gout | KRYSTEXXA® (pegloticase) for HCPs

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Percentage of patients treated with allopurinol or febuxostat who failed to reach a target sUA level of <6 mg/dL^1*

^*The primary efficacy endpoint was an sUA concentration of <6 mg/dL at each of the last 3 monthly measurements.¹

Charts showing percentages of patients who failed to reach target uric acid level on allopurinol at Month 12, with 79% not achieving sUA less than 6 mg/dL on 300 mg allopurinol/day (N = 251)

Charts showing percentages of patients who failed to reach target uric acid level on febuxostat at Month 12, with 47% not achieving sUA less than 6 mg/dL on 80 mg febuxostat/day (N = 255)

300 mg allopurinol/day for 52 weeks (n=251)

80 mg febuxostat/day for 52 weeks (n=255)

The lower the sUA level, the faster uric acid burden can resolve^2-8

Even at an sUA level of 5.4 mg/dL, it would take 2 years to dissolve a tophus the size of a small marble.^9†

Limitations of Diet

^†According to a long-term follow-up of 24 patients receiving a mean daily dose of 320 mg allopurinol.⁹

REDUCTION OF URIC ACID DEPOSITION

ONGOING URIC ACID DEPOSITION

0-4.0 mg/dL^2,3
4.1-5.9 mg/dL^2,10
>6.0 mg/dL^6-8

0-4.0 mg/dL^2,3

Potential to

Resolve tophi faster
Expedite the reduction of
uric acid burden

0-4.0 mg/dL^2,3
4.1-5.9 mg/dL^2,10
>6.0 mg/dL^6-8

4.1-5.9 mg/dL^2,10

Slow resolution of tophi
Decrease flare frequency

0-4.0 mg/dL^2,3
4.1-5.9 mg/dL^2,10
>6.0 mg/dL^6-8

>6.0 mg/dL^6-8

Uric acid continues to deposit in the joints and tissues, including organs
Flares can increase in frequency

Urate burden

Interested in learning more about uncontrolled gout and sUA? Connect with the KRYSTEXXA team to discuss.

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Identifying patients

See if your patients fit the criteria for uncontrolled gout

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Learn more about patients who might benefit from KRYSTEXXA

Actor portrayal of gout patient, James

Actor portrayal, not actual patient.

James

Occupation:

Middle school teacher

52-year-old with diabetes diagnosed with gout 15 years ago

Learn About James

Actor portrayal of gout and CKD Stage 3b patient, bet

Real patient

Bet

Occupation:

Stay-at-home parent

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

Learn About Bet

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.