Artist's rendition of KRYSTEXXA mechanism of action, displaying that only 10% of uric acid filtered through the kidneys is excreted while nearly all of allantoin filtered through the kidneys is excreted

Artist's rendition of KRYSTEXXA mechanism of action, displaying that only 10% of uric acid filtered through the kidneys is excreted while nearly all of allantoin filtered through the kidneys is excreted

Administering methotrexate, an immunomodulator, with KRYSTEXXA can reduce immunogenicity4,5*


When some patients receive a biologic, their immune system may see the drug as a foreign threat and develop antidrug antibodies (ADAs).6-8

ADAs can stop the biologic from working and lead to increased risk of infusion reactions.6

Giving an immunomodulator along with the biologic can reduce ADA formation. This should reduce the risk of infusion reactions and may improve patient response.6

*KRYSTEXXA alone may be used in patients for whom methotrexate is contraindicated or not clinically appropriate.

Letting your patients
know what to expect
during treatment

An everyday analogy may be a helpful way to explain to your patients how KRYSTEXXA dissolves crystal buildup within the body.
IMAGINE A SNOWY DAY…

Uric acid crystals build up over time in your body, similar to how snow collects on the sidewalk9,10

KRYSTEXXA is an enzyme that helps uric acid crystals dissolve, similar to how salt melts snow1,3

Dissolved uric acid crystals leave the body through the urine, similar to how melted snow flows down a drain1,3

This is a visual illustration of how KRYSTEXXA works over multiple treatments. Results may vary.

Giving your patients an overview of KRYSTEXXA treatment

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  • It’s not a medication patients will take for the rest of their lives
  • The optimal treatment duration for KRYSTEXXA has not been established; best results were seen at 6-12 months1
    • 4 weeks prior to treatment initiate 15 mg methotrexate once weekly with 1 mg folic acid daily
    • Administer 8 mg of KRYSTEXXA as an intravenous infusion every 2 weeks
    • Continue 15 mg methotrexate once weekly with 1 mg folic acid daily throughout treatment with KRYSTEXXA
  • Confirm the patient has normal G6PD activity and has discontinued other urate-lowering therapies
  • Perform sUA test prior to each infusion to ensure sUA <6 mg/dL
  • Confirm sUA level was tested, preferably in the last 48 hours
  • Administer pretreatment medications per prescribing orders of the doctor
  • 2-hour infusion (minimum)
  • Observation of patients for approximately an hour postinfusion should be considered
  • Remind patients of their next sUA test, upcoming infusion appointments, and any premedications they should continue taking, including corticosteroids, antihistamines, 15 mg methotrexate once weekly with 1 mg folic acid daily
  • Best results for KRYSTEXXA with methotrexate were seen at 6-12 months of treatment1
  • The optimal treatment duration has not been established

*KRYSTEXXA alone may be used in patients for whom methotrexate is contraindicated or not clinically appropriate.

G6PD deficiency is an abnormally low level of glucose-6-phosphate dehydrogenase. Patients of African, Mediterranean, and Southern Asian ancestry have a higher risk of G6PD deficiency.

G6PD, glucose-6-phosphate dehydrogenase; sUA, serum uric acid.

KRYSTEXXA with methotrexate can reduce sUA levels1‡


KRYSTEXXA with methotrexate provided >80% relative improvement in patient response during Month 6 and 94% relative improvement during Month 121

Seventy-one percent of patients receiving KRYSTEXXA with methotrexate (n=71/100) met the primary endpoint and had a complete sUA response at Month 6 vs 39% of patients receiving KRYSTEXXA alone (n=20/52)1

A multicenter, randomized double-blind trial of KRYSTEXXA with methotrexate vs KRYSTEXXA alone in adult subjects with uncontrolled gout.

sUA, serum uric acid.

KRYSTEXXA with methotrexate can help resolve tophi1,13


KRYSTEXXA with methotrexate improved tophi resolution by 74%

Fifty-four percent of patients (n=28/52) had complete resolution of at least 1 target tophus, with no new or progressive tophi, within the first year vs 31% (n=9/29) receiving KRYSTEXXA alone1

A series of DECT scans showing urate dissolution from baseline to Month 12

A series of DECT scans showing urate dissolution from baseline to Month 12

KRYSTEXXA can change the course of uncontrolled gout by dissolving years of systemic urate deposition.1

Green areas represent uric acid. Best results for KRYSTEXXA with methotrexate were seen at 6-12 months of treatment.1 The optimal treatment duration has not been established.

§Among patients with digital photograph of top at baseline; 53.3% of patients had tophi at baseline (total), n=81.

KRYSTEXXA can help real patients get their gout back under control

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.
  • Terkeltaub R, et al. Arthritis Res Ther. 2006;8(suppl 1):S4.
  • McDonagh EM, et al. Pharmacogenet Genomics. 2014;24:464-476.
  • Krieckaert C, et al. Arthritis Res Ther. 2010;12:217.
  • Remington G, et al. Int J MS Care. 2013;15(1):36-45.
  • Keenan RT, et al. Semin Arthritis Rheum. 2021;51:347-352.
  • Yun H, et al. Arthritis Care Res (Hoboken). 2017.
  • Cohen R, et al. J Pediatr Gastroenterol Nutr. 2019;69:551-556.
  • Doghramji PP, et al. Postgrad Med. 2012;124:98-109.
  • Schett G, et al. RMD Open. 2015;1(suppl 1):e000046.
  • Botson J, et al. J Clin Rheumatol. 2022;28:e129-e134.
  • Keenan RT, et al. Rheumatol Ther. 2019;6:299-304.
  • Data on File. Horizon, March 2022.