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CONSIDER KRYSTEXXA FOR YOUR UNCONTROLLED GOUT PATIENTS

KRYSTEXXA may be an appropriate treatment for your patients with uncontrolled gout who have an sUA >6 mg/dL and whose signs and symptoms are inadequately controlled despite treatment with xanthine oxidase inhibitors at the maximum medically appropriate dose, including patients with comorbid chronic kidney disease (CKD).1,2

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KRYSTEXXA IS EFFECTIVE FOR UNCONTROLLED GOUT PATIENTS WITH OR WITHOUT VISIBLE TOPHI1,2

The pivotal clinical trials of KRYSTEXXA included patients without visible tophi but with other signs and symptoms of gout.1

Not all patients with uncontrolled gout have visible tophi

  • 30% of patients had no visible tophi in the pivotal clinical trials1
  • All patients had failed to reach sUA <6 mg/dL despite ≥3 months of the maximum medically appropriate dose of allopurinol (or had a medical contraindication to allopurinol)2

Individual presentation and results may vary, even in patients without sustained response.

Visible tophi in hands before and after treatment with KRYSTEXXA Visible tophi in hands before and after treatment with KRYSTEXXA Visible tophi in hands before and after treatment with KRYSTEXXA

Individual presentation and results may vary, even in patients without sustained response.

CONTRAINDICATIONS: G6PD DEFICIENCY ASSOCIATED HEMOLYSIS AND METHEMOGLOBINEMIA

DO YOU HAVE PATIENTS LIKE OWEN OR MARK IN YOUR PRACTICE?

PATIENT HISTORY
  • 59-year-old diagnosed with gout 15 years ago
  • Currently not experiencing a gout flare, but averages 3-4 flares per year
  • Complains of not being able to wear his wedding ring
PHYSICAL AND LABORATORY WORKUP
  • 4 mm tophi located on the left hand between the 3rd and 4th MCP joints and a 5 mm tophus located on the 5th DIP joint of the right hand
  • sUA: 7.8 mg/dL
  • SCr: 1.2 mg/dL
  • G6PD: normal
CURRENT TREATMENTS
  • Colchicine: 0.6 mg PRN
  • Febuxostat: 80 mg QD
  • Following diet modification to the best of his ability

Tophi formation and bone erosion can continue independent of pain3-6

PATIENT HISTORY
  • 42-year-old diagnosed with gout 6 years ago
  • Reports history of flares in the right, first MTP joint; averaging 3-4 flares per year
  • Currently not experiencing a gout flare, but has low-grade pain in both feet and complains of having to buy larger shoes for walking around
PHYSICAL AND LABORATORY WORKUP
  • First MTP joint on both feet are tender and swollen. No palpable tophi detected
  • sUA level: 7.4 mg/dL
  • SCr: 0.8 mg/dL
  • G6PD: normal
  • A1C: 6.5%
CURRENT TREATMENTS
  • Colchicine: 0.6 mg PRN
  • Febuxostat: 80 mg QD
  • Metformin: 500 mg BID
  • Following diet modification to the best of his ability

The level of urate crystal burden may not be visually apparent7-9

G6PD=glucose-6-phosphate dehydrogenase.
Profile is representative of patient population.

References
  1. KRYSTEXXA (pegloticase) [prescribing information] Horizon.
  2. Yood RA, et al. BMC Res Notes. 2014;7:54.
  3. Doghramji PP, et al. Postgrad Med. 2012;124:98-109.
  4. Schett G, et al. RMD Open. 2015;1(suppl 1):1-5.
  5. Edwards NL. Gout A. Clinical features. In: Klippel JK, et al, eds. Primer on the Rheumatic Diseases. 13th ed. New York, NY: Springer: 2008:241-249.
  6. Khanna D, et al. Arthritis Care Res. 2012;64:1431-1446.
  7. Thiele RG, et al. Rheumatology (Oxford). 2007;46:1116-1121.
  8. Bongartz T, et al. Ann Rheum Dis. 2015;74:1072-1077.
  9. Choi HK, et al. Ann Rheum Dis. 2009;68:1609-1612.
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Indications and Usage

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.

Important Limitations of Use: KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.

Important Safety Information

WARNING: ANAPHYLAXIS AND INFUSION REACTIONS

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. However, delayed-type hypersensitivity reactions have also been reported. KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions. Patients should be premedicated with antihistamines and corticosteroids. Patients should be closely monitored for an appropriate period of time for anaphylaxis after administration of KRYSTEXXA. Monitor serum uric acid levels prior to infusions and consider discontinuing treatment if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed.

CONTRAINDICATIONS: G6PD DEFICIENCY ASSOCIATED HEMOLYSIS AND METHEMOGLOBINEMIA

Screen patients for G6PD deficiency prior to starting KRYSTEXXA. Hemolysis and methemoglobinemia have been reported with KRYSTEXXA in patients with G6PD deficiency. Do not administer KRYSTEXXA to these patients.

INDICATIONS AND USAGE

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.

Important Limitations of Use: KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.

IMPORTANT SAFETY INFORMATION

WARNING: ANAPHYLAXIS AND INFUSION REACTIONS

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. However, delayed-type hypersensitivity reactions have also been reported. KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions. Patients should be premedicated with antihistamines and corticosteroids. Patients should be closely monitored for an appropriate period of time for anaphylaxis after administration of KRYSTEXXA. Monitor serum uric acid levels prior to infusions and consider discontinuing treatment if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed.

The risk of anaphylaxis and infusion reactions is higher in patients who have lost therapeutic response.

Concomitant use of KRYSTEXXA and oral urate-lowering agents may blunt the rise of sUA levels. Patients should discontinue oral urate-lowering agents and not institute therapy with oral urate-lowering agents while taking KRYSTEXXA.

In the event of anaphylaxis or infusion reaction, the infusion should be slowed, or stopped and restarted at a slower rate.

Inform patients of the symptoms and signs of anaphylaxis, and instruct them to seek immediate medical care should anaphylaxis occur after discharge from the healthcare setting.

CONTRAINDICATIONS: G6PD DEFICIENCY ASSOCIATED HEMOLYSIS AND METHEMOGLOBINEMIA

Screen patients for G6PD deficiency prior to starting KRYSTEXXA. Hemolysis and methemoglobinemia have been reported with KRYSTEXXA in patients with G6PD deficiency. Do not administer KRYSTEXXA to these patients.

GOUT FLARES

An increase in gout flares is frequently observed upon initiation of anti-hyperuricemic therapy, including treatment with KRYSTEXXA. If a gout flare occurs during treatment, KRYSTEXXA need not be discontinued. 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 studied in patients with congestive heart failure, but some patients in the clinical trials experienced exacerbation. Exercise caution when using KRYSTEXXA in patients who have congestive heart failure and monitor patients closely following infusion.

ADVERSE REACTIONS

The most commonly reported adverse reactions in clinical trials with KRYSTEXXA are gout flares, infusion reactions, nausea, contusion or ecchymosis, nasopharyngitis, constipation, chest pain, anaphylaxis and vomiting.

Please see Full Prescribing Information and Medication Guide for more information.

INDICATIONS AND USAGE

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.

Important Limitations of Use: KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.

IMPORTANT SAFETY INFORMATION

WARNING: ANAPHYLAXIS AND INFUSION REACTIONS

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. However, delayed-type hypersensitivity reactions have also been reported. KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions. Patients should be premedicated with antihistamines and corticosteroids. Patients should be closely monitored for an appropriate period of time for anaphylaxis after administration of KRYSTEXXA. Monitor serum uric acid levels prior to infusions and consider discontinuing treatment if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed.

The risk of anaphylaxis and infusion reactions is higher in patients who have lost therapeutic response.

Concomitant use of KRYSTEXXA and oral urate-lowering agents may blunt the rise of sUA levels. Patients should discontinue oral urate-lowering agents and not institute therapy with oral urate-lowering agents while taking KRYSTEXXA.

In the event of anaphylaxis or infusion reaction, the infusion should be slowed, or stopped and restarted at a slower rate.

Inform patients of the symptoms and signs of anaphylaxis, and instruct them to seek immediate medical care should anaphylaxis occur after discharge from the healthcare setting.

CONTRAINDICATIONS: G6PD DEFICIENCY ASSOCIATED HEMOLYSIS AND METHEMOGLOBINEMIA

Screen patients for G6PD deficiency prior to starting KRYSTEXXA. Hemolysis and methemoglobinemia have been reported with KRYSTEXXA in patients with G6PD deficiency. Do not administer KRYSTEXXA to these patients.

GOUT FLARES

An increase in gout flares is frequently observed upon initiation of anti-hyperuricemic therapy, including treatment with KRYSTEXXA. If a gout flare occurs during treatment, KRYSTEXXA need not be discontinued. 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 studied in patients with congestive heart failure, but some patients in the clinical trials experienced exacerbation. Exercise caution when using KRYSTEXXA in patients who have congestive heart failure and monitor patients closely following infusion.

ADVERSE REACTIONS

The most commonly reported adverse reactions in clinical trials with KRYSTEXXA are gout flares, infusion reactions, nausea, contusion or ecchymosis, nasopharyngitis, constipation, chest pain, anaphylaxis and vomiting.

Please see Full Prescribing Information and Medication Guide for more information.

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