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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.
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.

How do I interpret screening results?
SCREENING CLASSIFICATION INTERPRETATION RECOMMENDATION1
Normal quantitative value OR negative qualitative result for deficiency. Patient does not have G6PD deficiency. Can proceed with treatment of
KRYSTEXXA as indicated.
Low quantitative value OR positive qualitative result for deficiency. Patient may have G6PD deficiency.† Do not administer KRYSTEXXA to patients with G6PD deficiency. If you have general questions regarding screening for G6PD deficiency, please call Medical Information at 866-479-6742.
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.†
RECOMMENDATION1 Can proceed with treatment of
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 866-479-6742.

Patients with hypersensitivity to KRYSTEXXA should not take KRYSTEXXA.

KRYSTEXXA is contraindicated for patients with a history of serious hypersensitivity reactions, including anaphylaxis, to KRYSTEXXA or any of its components.

†Acute hemolytic anemia, which may be the result of the patient’s medications, can produce inaccurate results. Additionally, if a patient has received a blood transfusion in the past 90 days, 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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Learn about Bet, a patient who benefited from KRYSTEXXA

Actor portrayal of gout patient, Bet

Patient name/age: Bet, 43
Occupation: Stay-at-home parent

Serum Uric Acid levels iconsUA >6 mg/dL

Gout flares icon2/year

Tophi iconvisible tophi

Learn About Bet

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.