Your Guide to Living With Chronic Gout

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Do I Have Refractory Chronic Gout (RCG)?

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$Do I Have Refractory Chronic Gout (RCG)?$

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WARNING: ANAPHYLAXIS and INFUSION REACTIONS

See full prescribing information for complete boxed warning.

Anaphylaxis and infusion reactions have been reported to occur during and after administration of KRYSTEXXA.
KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions.
Patients should be pre-medicated 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.

Indications and Usage

KRYSTEXXA^® (pegloticase) is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy.

Important Limitations of Use:
KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.

Important Safety Information

Before starting KRYSTEXXA^® (pegloticase), you should know that:

KRYSTEXXA is for adults who have tried or can not take oral gout medicines and still have high uric acid levels and gout symptoms, also known as refractory chronic gout.

KRYSTEXXA is not recommended if you have high levels of uric acid without symptoms of gout.

You should not receive KRYSTEXXA if you have a genetic condition known as G6PD deficiency, which stands for glucose-6-phosphate dehydrogenase. This is also known as favism. G6PD deficiency occurs more often in people of African or Mediterranean family background. However, it can occur in anyone. Before giving you KRYSTEXXA, your doctor may give you a blood test to determine if you have G6PD deficiency.

Before you receive KRYSTEXXA, tell your doctor if you:

Know you have G6PD deficiency
Have ever had any heart problems or high blood pressure
Are pregnant or planning to become pregnant. It is not known if KRYSTEXXA will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant
Are breastfeeding or plan to breastfeed. It is not known if KRYSTEXXA passes into your breast milk. You and your doctor should decide if you will receive KRYSTEXXA or breastfeed

What is the most important information I should know about KRYSTEXXA?

Serious allergic reactions may happen in some people who receive KRYSTEXXA. These allergic reactions can be life threatening and usually happen within 2 hours of the infusion.

KRYSTEXXA should be given to you by a doctor or nurse in a healthcare setting where serious allergic reactions can be treated. Your doctor or nurse should watch you for any signs of a serious allergic reaction during and after your treatment with KRYSTEXXA.

Tell your doctor or nurse right away if you have any of these symptoms during or after your treatment with KRYSTEXXA:

Wheezing, shortness of breath, cough, chest tightness, chest pain, or trouble breathing
Dizziness, fainting, fast or weak heartbeat or feeling nervous
Reddening of the face, itching, hives, or feeling warm
Swelling of the throat or tongue, throat tightness, hoarse voice or trouble swallowing

There are possible side effects with KRYSTEXXA:

The most common serious side effects in patients taking KRYSTEXXA were severe allergic reactions and infusion reactions. The most common side effects were gout flares or attacks, infusion reactions, nausea, bruising, sore throat, constipation, chest pain, severe allergic reactions, and vomiting.

An increase in gout flares is frequently observed in patients when they start taking medicines to lower their uric acid levels. Patients do not need to stop taking KRYSTEXXA simply because of gout flares.

Please see enclosed Medication Guide and Prescribing Information, including Boxed Warning.

You are encouraged to report negative side effects of prescription drugs to the FDA by visiting www.fda.gov/safety/medwatch or by calling the FDA at 1-800-FDA-1088.

Prescribing Information | Medication Guide

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