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

Evaluate Your Gout Patients Using“STOP”2

Click any card to learn more about STOP

Hand Icon sUA >6 Is their uric acid level >6 mg/dL? Hand Icon TOPHI Do they have nonresolving tophi? Hand Icon ORAL ULT FAILURE Have they been taking the maximum medically appropriate dose of ULTs? Hand Icon PAINFUL FLARES Have they had 2 or more painful flares in the past year?

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

up arrow icon up arrow icon>80% relative improvement in patient response during Month 6 when KRYSTEXXA was coadministered with methotrexate: 71% (n=71/100) vs 39% (n=20/52) complete sUA response compared to KRYSTEXXA alone1*

up arrow icon up arrow icon 94% relative improvement in patient response during Month 12 when KRYSTEXXA was coadministered with methotrexate: 60% (n=60/100) vs 31% (n=16/52) complete sUA response compared to KRYSTEXXA alone1*

See More Data

Relative Reduction in Infusion Reactions

up arrow icon up arrow icon 87% relative reduction in infusion
reactions: 4% (n=4/96) vs 31%
(n=15/49) compared to
KRYSTEXXA alone1

See More Data

*Complete sUA response: The endpoints were the proportion of responders, defined as patients achieving and maintaining sUA <6 mg/dL at least 80% of the time.

Learn more about patients who might benefit from KRYSTEXXA

Actor portrayal of gout and CKD patient, RichardActor portrayal of gout and CKD patient, Richard 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

Learn About Richard

Actor portrayal, not real patient.

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

Learn About Susan

Actor portrayal, not real patient.

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

Occupation:
Architect

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

Learn About Michael

Real patient.

CKD, chronic kidney disease.

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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sUA reduction guidelines

Find out what sUA level the American College of Rheumatology recommends to durably improve the signs and symptoms of gout.

Request Support

Identifying patients

Consider these types of patients with uncontrolled gout and see if KRYSTEXXA could be right for them.

Review Patient Characteristics

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.