KRYSTEXXA is indicated for the treatment of chronic gout in adult patients refractory to conventional therapy.1

Evaluate Your Gout Patients Using “STOP”2
sUA>6

Is their uric acid level
>6 mg/dL?

TOPHI

Do they have nonresolving tophi?

ORAL ULT FAILURE

Have they been taking the maximum medically appropriate dose of ULTs?

PAINFUL FLARES

Have they had 2 or more painful flares in the past year?

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Explore Patient Profiles About KRYSTEXXA

Uncontrolled gout is not defined by having all of the criteria above. KRYSTEXXA is not indicated for the treatment of pain.

sUA, serum uric acid; ULT, urate-lowering therapy.

KRYSTEXXA with methotrexate

Improved
efficacy

>80% relative improvement in patient response; 71% vs 39% complete sUA response* compared to KRYSTEXXA alone during Month 61

Reduced infusion reactions

87% relative reduction in infusion reactions; 4% vs 31% compared to KRYSTEXXA alone1

Improved confidence

With fewer infusion reactions and improved patient response, you can confidently reduce years of urate burden1

*Complete sUA response: sUA <6 mg/dL ≥80% of the time during Month 6.1

2020 ACR GUIDELINES
Pegloticase is STRONGLY RECOMMENDED for your patients with uncontrolled gout2†

For your uncontrolled gout patients who:

Pain

Fail to normalize sUA levels on the maximum medically appropriate dose of ULTs (eg, allopurinol or febuxostat)2

AND HAVE

Redness

Frequent flares
(≥2 flares per year)2

AND/OR

Chart prevalence

Nonresolving tophi2

†In the KRYSTEXXA clinical trials, uncontrolled gout was defined as ongoing gout symptoms (≥1 tophus, ≥2 gout flares a year, and/or chronic gouty arthritis) with failure to normalize sUA under 6 mg/dL after at least 3 months of allopurinol treatment at the maximum medically appropriate dose or a self-reported contraindication.1,2

ACR, American College of Rheumatology.

†In the KRYSTEXXA clinical trials, uncontrolled gout was defined as ongoing gout symptoms (≥1 tophus, ≥2 gout flares a year, and/or chronic gouty arthritis) with failure to normalize sUA under 6 mg/dL after at least 3 months of allopurinol treatment at the maximum medically appropriate dose or a self-reported contraindication.1,2

ACR, American College of Rheumatology.

Stay informed for your
patients and practice.

Support for your patients

Managing uncontrolled gout can involve a lot of moving parts. Amgen By Your Side is a support program for patients prescribed KRYSTEXXA. Our dedicated team is your patient’s partner, committed to providing nonmedical support so they can start and continue on treatment as you prescribe.

See Support Program

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Need more data?

The KRYSTEXXA team is available to share more about the systemic nature of uncontrolled gout.

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Systemic burden

Uncontrolled gout is a chronic and systemic disease that affects patients beyond the joints.3,4

Learn More

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.

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.

  • KRYSTEXXA (pegloticase) [prescribing information] Horizon.
  • FitzGerald JD, et al. Arthritis Care Res (Hoboken). 2020;72:744-760.
  • Doghramji PP, et al. Postgrad Med. 2012;124:98-109.
  • Dalbeth N, et al. Lancet. 2016;388:2039-2052.