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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
  • Stop oral ULTs (1 week prior to first infusion)
  • Ensure compliance to methotrexate and folic acid regimen

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

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 co-administration with methotrexate and folic acid, this should be maintained throughout treatment with KRYSTEXXA.

G6PD, glucose-6-phosphate dehydrogenase; sUA, serum uric acid; ULT, urate-lowering therapy.

G6PD deficiency screening

KRYSTEXXA is contraindicated in patients with G6PD deficiency.1,2

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

David, CKD stage 3b

Occupation:
College professor

57-year-old with CKD stage 3b due to type 2 diabetes, diagnosed with gout 8 years ago

Learn About David

Actor portrayal, not actual patient.

Actor portrayal of gout and CKD Stage 4 patient, Lisa Actor portrayal of gout and CKD Stage 4 patient, Lisa Actor portrayal of gout and CKD Stage 4 patient, Lisa

Lisa, CKD stage 4

Occupation:
Office manager

58-year-old with CKD stage 4 due to ADPKD, diagnosed with gout 7 years ago

Learn About Lisa

Actor portrayal, not actual patient.

ADPKD, autosomal dominant polycystic kidney disease.

Actor portrayal of gout and kidney transplant patient, Harold Actor portrayal of gout and kidney transplant patient, Harold Actor portrayal of gout and kidney transplant patient, Harold

Harold, transplant patient

Occupation:
Journalist

64-year-old with type 2 diabetes, hypertension, and end-stage renal disease

Learn About Harold

Actor portrayal, not actual patient.

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.
  • Keenan RT, et al. Rheumatol Ther. 2019;6:299-304.