YOUR GUIDE TO INFUSING KRYSTEXXA

KRYSTEXXA is an infusion drug, and like all infusion drugs, there are steps that your office needs to take to prepare your patients for infusion, and to ensure that KRYSTEXXA is administered properly.

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PROCESS FOR NEW PATIENTS

STEP 1: IDENTIFY SITE OF CARE AND SUBMIT SERVICE REQUEST FORM (SEE BELOW)

Initiates enrollment into KRYSTEXXAConnect services, including PATIENT ACCESS MANAGER

Within 2 business days:

You receive an Initial Summary of Benefits and your patient receives a Welcome Kit

STEP 2: CONFIRM NORMAL G6PD* ACTIVITY FROM LAB TESTS AND THAT URATE-LOWERING THERAPIES HAVE BEEN DISCONTINUED

If using an Alternate Site of Care (ASOC), refer to ASOC Letter Template (see below)

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

KRYSTEXXAConnect Enrollment Form

Starting a patient on KRYSTEXXA? Get them connected to their Patient Access Manager faster by completing this enrollment form.

DOWNLOAD FORM

Alternate Site of Care Letter – Template

Download the following resource to recommend infusion of KRYSTEXXA. This template is a suggestion and should be printed on the physician’s letterhead. The physician is responsible for completing this letter in a way that completely and accurately represents a patient’s circumstances.

DOWNLOAD LETTER DOWNLOAD INSTRUCTIONS

Preinfusion Medications

Download this guide to see if your patients should take an antihistamine, analgesic, or IV corticosteroid prior to infusing KRYSTEXXA.

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STEPS TO A SUCCESSFUL INFUSION DAY

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 Stopping Rules

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

A Patient Access Manager (PAM) is available to support the patient throughout therapy

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

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.

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Infusion Checklist

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

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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 Full Prescribing Information
Reference
  1. KRYSTEXXA [prescribing information]. Horizon Pharma Rheumatology LLC.
For U.S. Healthcare Professionals  |  Patient Site

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.