Frequently Asked Questions about KRYSTEXXA®

What is Refractory Chronic Gout (RCG)?

When uric acid levels remain high and gout signs and symptoms won't go away over time with treatment, this type of gout may be chronic and refractory. Signs and symptoms of RCG may be:

  • Frequent, painful flare-ups
  • Pain or swelling in the joints, which is known as "gouty arthritis"
  • Lumps or deposits of uric acid crystals under the skin, called tophi

If standard gout medicine has not worked for me, will KRYSTEXXA work?

KRYSTEXXA works differently than standard gout medicines. It breaks uric acid down into a substance that your body can remove more easily in the urine. As a result, KRYSTEXXA may work in your case.

How is KRYSTEXXA given?

KRYSTEXXA is given every 2 weeks by intravenous (IV) infusion through a needle placed in a vein in your arm. This is usually done at your doctor's office, at a hospital, or at an infusion center. The infusion takes about 2 hours, but your doctor or nurse will have you come in beforehand to take pre-medicines, and they may watch you for an additional hour after your infusion to make sure that you don't have any problems.

What should I know about KRYSTEXXA treatment?

  • Severe allergic reactions can happen during or shortly after receiving KRYSTEXXA. Symptoms may include wheezing, shortness of breath, coughing, chest tightness, chest pain, trouble breathing, dizziness, fainting, fast or weak heartbeat or feeling nervous, reddening of the face, itching, hives, feeling warm, swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing. Tell your doctor or nurse immediately if you have any of these symptoms during or at any time after receiving KRYSTEXXA
  • Infusion reactions can happen during or shortly after receiving any type of medicine by infusion. Your doctor will prescribe medicines for you to take before the infusion. These medicines will help prevent or lessen the severity of these reactions. It's important that you take these medicines as directed
  • When you start taking KRYSTEXXA, you may have more flare-ups. It is important to understand that this may be because KRYSTEXXA is breaking down uric acid in your body. You do not need to stop taking KRYSTEXXA because of a flare-up. In fact, a flare-up may mean that KRYSTEXXA is beginning to work
  • You should let your doctor know if you have a history of heart disease before starting treatment with KRYSTEXXA. KRYSTEXXA was not formally studied in people with heart disease not controlled by medicine. Talk to your doctor if you have ever been told you have congestive heart failure
  • The most common side effects were gout flare-ups, infusion reactions, nausea, bruising, sore throat, constipation, chest pain, severe allergic reactions, and vomiting

Why do I have to take a blood test every 2 weeks?

Your doctor will order a blood test to check your uric acid levels before each KRYSTEXXA infusion. This is because infusion reactions occur most often in people whose uric acid levels do not stay below 6 mg/dL. Your test results will help your doctor know if it's right for you to keep taking KRYSTEXXA. If the results show that KRYSTEXXA is not controlling your uric acid, you will have to stop treatment. This is important because only people who are being helped by KRYSTEXXA should keep getting it.

What is the KRYSTEXXA® Connexxions Patient Support Program?

The KRYSTEXXA Connexxions Patient Support Program is a service and resource program that's free for all KRYSTEXXA patients. The program provides personal support from a trained professional, insurance coverage assistance, and informative brochures—all designed to make your treatment with KRYSTEXXA as simple and convenient as possible. To sign up for the KRYSTEXXA Connexxions Patient Support Program, click here or call 1-888-633-9521





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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 signs and symptoms, also known as Refractory Chronic Gout.

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

You should not use KRYSTEXXA if you have a genetic condition known as G6PD deficiency, which stands for glucose-6-phosphate dehydrogenase deficiency. 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, or ever had, 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 flare-ups 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.

This is not a complete list of all possible side effects. Ask your doctor or treatment team if you have any questions or want more information.

If you have any questions about KRYSTEXXA or your therapy, talk with your doctor.

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

Please see the Medication Guide and Prescribing Information, including Boxed Warning, for more information.

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