Administration1

  • KRYSTEXXA should be administered in healthcare settings 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 discontinue treatment if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed
  • The pegloticase admixture should only be administered by intravenous infusion slowly, over no less than 120 minutes via gravity feed, syringe-type pump, or infusion pump

Dosing1

KRYSTEXXA co-administration with methotrexate

STEP 1

4 WEEKS PRIOR TO TREATMENT

15 mg methotrexate QW
WITH 1 mg folic acid PO QD

The optimal treatment duration of KRYSTEXXA has not been established.

STEP 2

beaker icon

8 mg intravenous infusion Q2W

15 mg methotrexate QW
WITH 1 mg folic acid PO QD

PO, provided orally; QD, every day; QW, every week; Q2W every 2 weeks.

Methotrexate may not be appropriate for all patients, in these instances, KRYSTEXXA can be administered alone.

Methotrexate

Product information1

KRYSTEXXA is a clear, colorless, sterile 8-mg solution of pegloticase in a 2-mL single-use vial, expressed as amounts of uricase protein. KRYSTEXXA must be diluted prior to use.

Steps to a successful infusion day

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  • Prior to the first infusion, confirm the patient has normal G6PD activity from lab tests and has discontinued taking urate-lowering therapies (eg, allopurinol and febuxostat)*
    • Do not administer KRYSTEXXA to patients with G6PD deficiency and if the patient is hypersensitive to KRYSTEXXA

  • Remind patients why they are not taking urate-lowering therapies and ensure they are taking gout flare prophylaxis
  • Prior to each subsequent infusion, confirm sUA level was tested in the last 48 hours, beginning after the first infusion. Notify prescribing healthcare provider if sUA level has not been tested or if any preinfusion sUA level is >6 mg/dL, and discontinue therapy, particularly after 2 preinfusion sUA levels are >6 mg/dL. See the KRYSTEXXA Monitoring Protocol
  • Patient should take prescribed medications, including methotrexate and oral folic acid.
    • If prescribing KRYSTEXXA with methotrexate therapy, this should be maintained throughout treatment with KRYSTEXXA

  • Answer any questions the patient may experience regarding treatment, including education on the limitations of diet changes in the treatment of uncontrolled gout, and provide a Medication Guide
  • Describe to the patient how KRYSTEXXA works, including the risk of infusion reactions
  • Remind the patient of support services available to them through Horizon By Your Side once they are enrolled
  • Administer preinfusion medications per prescribing healthcare provider’s orders
    • IV corticosteroid
    • Antihistamine
    • Oral analgesic
  • Remind the patient that they may experience gout flares, but KRYSTEXXA therapy can be continued regardless of gout flares
  • Visually inspect vial for particulate matter and ensure solution is clear and colorless
  • Using aseptic technique, withdraw 1 mL into a sterile syringe and inject into a 250-mL bag of normal or half-normal saline. Gently mix the bag by inverting several times and discard any unused portion of the remaining product. Do not shake
    • No loading dose recommended or required
    • KRYSTEXXA is a single-dose vial
  • The diluted solution should be used within 4 hours
  • Before administration, allow the diluted solution of KRYSTEXXA to reach room temperature
    • Artificial heating should not be used
    • If not administered immediately, it is recommended that the diluted solution should be stored in the refrigerator and away from light
  • Initiate infusion at a rate of 125 mL/h or slower via infusion pump or gravity feed
  • Infuse over no less than 2 hours

DO NOT ADMINISTER AS INTRAVENOUS PUSH OR BOLUS

  • The sticker on the KRYSTEXXA box is available for use on your patient’s chart, if desired
  • Use your normal protocol to monitor for infusion reactions
    • In the event of an infusion reaction, as clinically indicated, the infusion can be slowed or stopped and restarted at a slower rate
  • Closely monitor for anaphylaxis for 1 hour period after administration of KRYSTEXXA
  • Remind the patient of their next sUA test and KRYSTEXXA infusion appointments along with taking prescribed medications, including methotrexate and folic acid
    • KRYSTEXXA should be given every 2 weeks—it is recommended to provide a standing order to the lab to check the patient’s sUA level prior to each infusion

*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 South Asian ancestry have a higher risk of deficiency.1

sUA, serum aric acid.

Preinfusion Medications

See which medications your patients should take prior to infusing KRYSTEXXA.

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Ready to prepare your patient for the first infusion?

Connect with the KRYSTEXXA team to discuss.

G6PD deficiency screening

KRYSTEXXA is contraindicated in patients with G6PD deficiency.1,2

Monitoring protocol

Preinfusion sUA is a powerful biomarker for predicting infusion reactions.

sUA, serum uric acid.

Learn about patients who might benefit from KRYSTEXXA

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.
  • Belfield KD, et al. Am J Health-Syst Pharm. 2018;75(3):97-104.
  • Baraf HSB, et al. J Clin Rheumatol. 2014;20(8):427-432.