Key Inclusion/Exclusion Criteria3

Inclusion

  • Adult patients ≥18 years old with diagnosis of gout
  • Uncontrolled gout, defined as (all required)
    • Serum uric acid (sUA) ≥7 mg/dL
    • Oral urate lowering therapy failure/intolerance
    • ≥1 ongoing gout symptom (≥1 tophus, ≥2 flares in the year prior to screening and/or chronic gouty arthritis)

Exclusion

  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • eGFR <40 mL/min/1.73 m2
  • MTX contraindication/known intolerance
  • Elevated LFTs, low albumin or low blood cell counts
eGFR, estimated glomerular filtration rate; LFTs, liver function tests; MTX, methotrexate.

Family history, health literacy, and socioeconomic environment are contributing factors to gout becoming uncontrolled18,19

Two major factors contribute to uric acid buildup and crystallization18,19

Genetics
Gout runs in the family
Kidney damage
Impaired uric acid elimination
Additional contributing factors include4,18,20,21:
  • Diet and lifestyle
  • Age
  • Comorbidities
  • Metabolism
Diet is not a substitute for treatment as dietary restrictions may reduce uric acid levels by only ~1 mg/dL13,22

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Contraindications

Important: Confirm the screening results for G6PD deficiency prior to the first infusion

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KRYSTEXXA is contraindicated in patients with G6PD deficiency1,2

  • G6PD-deficient patients may experience life-threatening hemolytic reactions and methemoglobinemia
  • It is important to test patients for G6PD deficiency prior to initiating treatment because they often appear asymptomatic and will likely not be aware of this deficiency
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  • What is G6PD deficiency?

    G6PD deficiency is a genetic disorder that causes red blood cells to break down prematurely or in response to certain medications, including KRYSTEXXA. It is the most common enzyme deficiency disorder of red blood cells worldwide.3,4

  • Who is at the greatest risk?

    G6PD deficiency is the most common enzyme deficiency disorder of red blood cells, affecting 400 million people worldwide. G6PD predominantly affects males, particularly those of African, Mediterranean, or South Asian ancestry.4,5

  • When do I screen my patients?

    Unlike the serum uric acid (sUA) test, which should be performed prior to each infusion, the G6PD deficiency screening should be conducted 1 time, prior to the first infusion.1*

  • How do I screen my patients?*

    Perform a standard blood draw for lab analysis. Either a qualitative or quantitative screening can be ordered to determine G6PD deficiency.5
*Because the test results are typically returned within 2 to 3 days, G6PD deficiency screening is recommended at the time the service request form is submitted or as early as possible.
G6PD, glucose-6-phosphate dehydrogenase

Confirm the screening results for G6PD deficiency or hypersensitivity prior to the first infusion1

G6PD

SCREENING CLASSIFICATION
Normal quantitative value
OR
negative qualitative result for deficiency
Low quantitative value
OR
positive qualitative result for deficiency
INTERPRETATION
Patient does not have G6PD deficiency†
Patient may have G6PD deficiency
RECOMMENDATION
Can proceed to treatment with KRYSTEXXA as indicated
Do not administer KRYSTEXXA to patients with G6PD deficiency.
If you have general questions regarding screening for G6PD deficiency, please call Medical Information at 1-866-479-6742

Hypersensitivity1

KRYSTEXXA is contraindicated for patients with a history of serious hypersensitivity reactions, including anaphylaxis, to KRYSTEXXA or any of its components.
*Acute hemolysis, which may be caused by the patient’s medications, can produce inaccurate results. Additionally, if a patient has received a blood transfusion, the transfusion could alter the test results.. For either of these situations, postpone testing or consider retesting in 2 to 3 months.2,4

Need more information on screening for G6PD deficiency?

Connect with the KRYSTEXXA team to discuss.

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Patient support

Amgen By Your Side provides patients with personalized nonmedical support once they are prescribed KRYSTEXXA.

See Resources

Learn more about patients who might benefit from KRYSTEXXA

Actor portrayal of patient with no visible tophi

Michelle

Occupation:
Nurse

59-year-old with no visible tophi, but has pain and tenderness in her hands; diagnosed with gout 5 years ago

Actor portrayal, not actual patient.

Learn About Michelle
Actor portrayal of patient with pain who was diagnosed with gout years ago

Andrew

Occupation:
Real estate agent

56-year-old with hypertension and pain in hands and feet; diagnosed with gout 8 years ago

Actor portrayal, not actual patient.

Learn About Andrew
Real KRYSTEXXA patient, Bet

Bet

Occupation:
Stay-at-home parent

43-year-old diagnosed with gout over 20 years ago

Real patient.

Learn About Bet

KRYSTEXXA is not indicated for the treatment of pain.

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.

  • References
    • KRYSTEXXA (pegloticase) [prescribing information] Horizon.
    • Baraf HSB, et al. J Clin Rheumatol. 2014;20:427-432.
    • Keenan RT, et al. Rheumatol Ther. 2019;6:299-304.
    • Strand V, et al. BioDrugs. 2017;31:299-316.
    • Lombardi G, et al. BMJ Open. 2016;6:1-7.
    • Sundy JS, et al. JAMA. 2011;306:711-720.

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.