Patient populations of interest

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 co-morbid chronic kidney disease (CKD).1,2

The 2012 American College of Rheumatology (ACR) Guidelines recommend lowering sUA level to a minimum of <6 mg/dL. Moreover, the ACR recommends lowering the sUA level sufficiently to durably improve the signs and symptoms of gout, which may require a therapeutic sUA level of <5 mg/dL.3

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.

*KRYSTEXXA is contraindicated for patients with G6PD deficiency. 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.1

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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

Visible tophi in hands before and after treatment with KRYSTEXXA

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

Not all patients with uncontrolled gout have visible tophi

30% of patients had no visible tophi in the pivotal clinical trial1

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

KRYSTEXXA IS SAFE AND EFFECTIVE FOR PATIENTS WITH UNCONTROLLED GOUT AND CKD1,2

Pivotal clinical trials

32% of patients in the pivotal clinical trials had creatinine clearance <62.5 mL/min1

Estimation of glomerular filtration rate (eGFR) from serum creatinine remains the clinical standard worldwide to determine renal function.4-7

Pie chart Pie chart

Post hoc analysis

38% of patients had stage 3 CKD and
11% had stage 4 CKD, as determined by eGFR2

Patients with CKD can be effectively treated with KRYSTEXXA without dose adjustment1

CKD patients experienced similar reductions in sUA levels compared with patients without CKD1,2

oThere was no difference in efficacy of KRYSTEXXA across CKD stages 1, 2, 3, and 4

The safety profile of KRYSTEXXA was demonstrated to be the same in patients with or without CKD, and across all CKD stages1,2

KRYSTEXXA did not affect the eGFR during the 25-week treatment period2

No dose adjustment is required for patients with renal impairment.

A phase 1 study (N=12) was conducted in non-gout patients with CKD stage 5 (end-stage renal disease, or ESRD) to evaluate the effect of hemodialysis on the pharmacokinetics of a single dose of KRYSTEXXA8

This study showed no effect of hemodialysis on the safety or efficacy of KRYSTEXXA8

CKD stage 5 (ESRD) patients are routinely excluded from clinical trials for gout and were also excluded from the KRYSTEXXA pivotal clinical trials8,9

The results of a single injection indicated that8:

oReductions in sUA levels were similar to those achieved in the pivotal clinical trials

oKRYSTEXXA was not removed during dialysis treatment

oIn this study, KRYSTEXXA was well tolerated and there did not appear to be a change in the incidence, type, or severity of adverse events

References
  1. KRYSTEXXA [prescribing information]. Horizon Pharma Rheumatology LLC.
  2. Yood RA, et al. BMC Res Notes. 2014;7:54.
  3. Khanna D, et al. Arthritis Care Res (Hoboken). 2012;64(10):1431-1446.
  4. Levey AS, et al. Ann Intern Med. 1999;130(6):461-470.
  5. Levey AS, et al; Ann Intern Med. 2009;150(9):604-612.
  6. Michels WM, et al. Clin J Am Soc Nephrol. 2010;5(6):1003-1009.
  7. Poggio ED, et al. J Am Soc Nephrol. 2005;16(2):459-466.
  8. Bleyer AJ, et al. Clin Nephrol. 2015;83(5):286-292.
  9. Sundy JS, et al. JAMA. 2011;306(7):711-720.
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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.