PROCESS FOR NEW PATIENTS

STEP 1:

INITIATE YOUR PATIENT’S ENROLLMENT IN HORIZON PATIENT SERVICES BY SUBMITTING THE PATIENT ENROLLMENT FORM (PEF)

Your patient must complete enrollment to access our patient-focused services and resources

  • You receive an initial Summary of Benefits and your patient receives a Welcome Kit
STEP 2:

IDENTIFY YOUR PATIENT'S INFUSION CENTER

  • Order lab work
    • Glucose-6-phosphate dehydrogenase (G6PD) deficiency*: Do not administer KRYSTEXXA if patient has a G6PD deficiency
    • Serum uric acid (sUA): Baseline sUA is typically required
  • Confirm urate-lowering therapies have been discontinued
STEP 3:

INFUSE WITH KRYSTEXXA

Perform preinfusion sUA test, preferably within 48 hours prior to each infusion (with exception of the first infusion)

  • Predictive biomarker for infusion reactions risk and product efficacy

Infusion

  • 2-hour infusion (minimum)
  • 1 hour of observation (recommended)

Alternate Text


Patient Enrollment Form

Choose one of two convenient options to initiate and submit the Patient Enrollment Form (PEF).

DocuSign eSignature Patient Enrollment Form

Begin the form and send to your patient over email to complete via DocuSign.

Begin here

Downloadable Patient Enrollment Form

Print, complete with your patient, and fax OR email the form to 1-877-633-9522 OR PatientServices@
horizontherapeutics.com

Alternate Site of Care Letter Template

Download the suggested template below to draft a letter to recommend KRYSTEXXA infusion. The final letter should completely and accurately represent a patient’s circumstances and be printed on the physician’s letterhead.

Preinfusion Medications

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

STEPS TO A SUCCESSFUL INFUSION DAY

Icon Confirm

STEP 1: CONFIRM

  • Prior to the first infusion, confirm the patient has normal G6PD* activity from lab tests and has discontinued taking urate-lowering therapies (eg, allopurinol, febuxostat)
    • Do not administer KRYSTEXXA to patients with G6PD deficiency
  • Prior to each subsequent infusion, confirm sUA level was tested in the last 48 hours, beginning after the first infusion. Notify prescribing healthcare provider (HCP) if sUA level has not been tested or if any preinfusion sUA level is ≥6 mg/dL, and consider discontinuing therapy, particularly after 2 preinfusion sUA levels are >6 mg/dL. See the KRYSTEXXA Monitoring Protocol
Icon counsel

STEP 2: COUNSEL

  • Answer any questions the patient may have regarding treatment and provide a Medication Guide
  • Remind the patient that they may have gout flares, and KRYSTEXXA therapy can be continued regardless of gout flares
Icon prepare

STEP 3: PREPARE AND ADMINISTER

  • Administer preinfusion medications per prescribing HCP’s orders. See Prescribing Information
  • 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
  • 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
Icon observe

STEP 4: OBSERVE AND REMIND

  • Observe the patient for approximately 1 hour post-infusion
  • Remind the patient of their next sUA test and KRYSTEXXA infusion appointments
    • 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 Southern Asian ancestry have a higher risk of deficiency.1

Available through Group Purchasing Organization (GPO) wholesalers and specialty pharmacies, depending on patient benefit design.

Infusion checklistInfusion checklistInfusion checklist

Infusion Checklist

Make sure you perform every step of the infusion process for KRYSTEXXA by downloading the Infusion Checklist.

Download checklist
Infusion protocolInfusion protocolInfusion protocol

Infusion Protocol

Download and fill out this infusion protocol template to give preinfusion medication and infusion instructions to an Alternate Site of Care.

Download template

DOSING &
PREPARATION

Find out the recommended dose and regimen of KRYSTEXXA, and how to prepare KRYSTEXXA and your patients for infusion.

MONITORING
PROTOCOL

In a post hoc analysis, preinfusion sUA was revealed as a powerful biomarker for predicting infusion reactions. From this, a simple monitoring protocol was established.

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

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.

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

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

  • KRYSTEXXA (pegloticase) [prescribing information] Horizon.