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UNDERSTANDING GOUT

If you take oral gout medicine and still experience gout symptoms, your gout may be out of control. Your flares may also become more frequent and severe, occur in other joints, or you may develop visible lumps of uric acid crystal buildup (tophi). Take a short quiz.

In addition to more frequent and severe gout flares, out-of-control chronic gout has been linked to serious health issues, including heart attack, stroke, and insulin resistance. Lumps of uric acid crystal buildup, called tophi can develop over time and lead to other complications.

GOUT CAUSES

Gout is caused by too much uric acid in your blood. It’s rarely caused by diet, though certain foods can trigger a gout attack. Over time, uric acid crystals can form and settle in your joints. If gout remains out of control, it could lead to permanent joint and bone damage.

Uric acid is produced when your body breaks down purines found naturally in your body and in certain foods. Normally, uric acid dissolves in your blood and is removed through your kidneys. However, if you produce too much uric acid, or remove too little, the uric acid can form into tiny needle-like crystals that settle in your joints and surrounding tissues. KRYSTEXXA works differently to remove uric acid.

GOUT SIGNS & SYMPTOMS

When uric acid crystals accumulate in your joints it can cause gout flares, which are characterized by inflammation, redness, swelling, tenderness and intense pain. Visible lumps called tophi can also form. Your doctor will test your uric acid level to determine whether or not your signs and symptoms are the result of gout.

Over time, uric acid crystals can accumulate in new areas of your body, causing you to experience flares and damage in more places. That’s one sign your gout is out of control.

Tophi (TOE-f-EYE) are hard lumps of uric acid crystals that build up so much they become visible. The big toe is a common place to develop tophi, but they can also form on your hands, elbows, knees and almost anywhere, even in your organs. Everyone is at risk of developing tophi if gout stays out of control for too long.

GOUT DURATION

Even when you’re not having a flare, you still have the underlying condition that causes gout. Take control of chronic gout by dissolving uric acid crystal buildup and keeping your uric acid level low enough to prevent new buildup.

The more uric acid builds up, the more at risk you are of permanently damaging your joints and bones.

TAKING KRYSTEXXA

KRYSTEXXA is a delicate enzyme that would be destroyed in your stomach if taken as a pill.

Yes. People in the clinical studies had the best results when they were given KRYSTEXXA every 2 weeks.

While taking KRYSTEXXA, do not take any other uric acid lowering drugs, such as Zyloprim® (allopurinol) or Uloric® (febuxostat). Your doctor or gout specialist may give you medicine (colchicine and/or NSAIDs) to help with any gout flares you may have while on KRYSTEXXA. In preparation for your KRYSTEXXA IV treatment, your doctor may also give you antihistamines and corticosteroids.

Making time for your IV treatments can be challenging, but in order to see the best results with KRYSTEXXA, it’s important to receive your IV treatment every 2 weeks. If you are going to miss an appointment, contact your doctor or gout specialist as soon as possible to reschedule.

KRYSTEXXA starts working within 24 hours. People in the clinical studies were given KRYSTEXXA for about 6 months in order to stay in the dissolve zone to get rid of years of uric acid crystal buildup.

You and your doctor will decide on a plan to keep uric acid crystals from building up again.

KRYSTEXXA SIDE EFFECTS

With KRYSTEXXA, gout flares are a common side effect, but many people in the clinical studies said they were having fewer flares by the end of treatment. Your doctor may give you medicine (colchicine and/or NSAIDs) to help with any gout flares you may have while on KRYSTEXXA.

A nurse or assistant will be with you to ensure any allergic reactions are treated. In the clinical studies, all allergic reactions, including serious allergic reactions, were treated at the IV treatment center with medicine or by stopping the IV treatment. Most were resolved using common medications such as Benadryl®.

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IMPORTANT SAFETY INFORMATION

Intended for U.S residents only.

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

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

USE

KRYSTEXXA is a prescription medicine used in adults to help reduce the signs and symptoms of gout that are not controlled by other treatments.

IMPORTANT SAFETY INFORMATION

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

Serious allergic reactions may happen in some patients 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, rash, or feeling warm
  • Swelling of the throat or tongue, throat tightness, hoarse voice or trouble swallowing

Who should not receive KRYSTEXXA?

Do not receive KRYSTEXXA if you have a rare blood problem called glucose 6-phosphate dehydrogenase (G6PD) deficiency or favism. Your doctor should test you for G6PD before you start KRYSTEXXA.

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

Before you receive KRYSTEXXA, tell your doctor if you:

  • Know you have G6PD deficiency
  • 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
  • Are breastfeeding or plan to breastfeed. It is not known if KRYSTEXXA passes into your breast milk

Tell your doctor about all the medicines you take. Do not take any other uric acid lowering drug, such as allopurinol or febuxostat (Uloric®), while taking KRYSTEXXA.

Prior to your treatment with KRYSTEXXA, your doctor may give you medicine to help reduce your chance of getting a reaction. Take these medicines as directed by your doctor or nurse. Your doctor will also test your uric acid levels prior to each treatment to monitor your response to KRYSTEXXA.

What are the possible side effects of KRYSTEXXA?

Please review important information section above. The most common side effects in patients taking KRYSTEXXA were gout flare-ups or attacks, allergic reactions, nausea, bruising, sore throat, constipation, chest pain, and vomiting.

This is not a complete list of all possible side effects. Tell your doctor or treatment team if you have any side effect that bothers you or that does not go away.

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

IMPORTANT SAFETY INFORMATION

Intended for U.S residents only.

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

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

USE

KRYSTEXXA is a prescription medicine used in adults to help reduce the signs and symptoms of gout that are not controlled by other treatments.

IMPORTANT SAFETY INFORMATION

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

Serious allergic reactions may happen in some patients 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, rash, or feeling warm
  • Swelling of the throat or tongue, throat tightness, hoarse voice or trouble swallowing

Who should not receive KRYSTEXXA?

Do not receive KRYSTEXXA if you have a rare blood problem called glucose 6-phosphate dehydrogenase (G6PD) deficiency or favism. Your doctor should test you for G6PD before you start KRYSTEXXA.

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

Before you receive KRYSTEXXA, tell your doctor if you:

  • Know you have G6PD deficiency
  • 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
  • Are breastfeeding or plan to breastfeed. It is not known if KRYSTEXXA passes into your breast milk

Tell your doctor about all the medicines you take. Do not take any other uric acid lowering drug, such as allopurinol or febuxostat (Uloric®), while taking KRYSTEXXA.

Prior to your treatment with KRYSTEXXA, your doctor may give you medicine to help reduce your chance of getting a reaction. Take these medicines as directed by your doctor or nurse. Your doctor will also test your uric acid levels prior to each treatment to monitor your response to KRYSTEXXA.

What are the possible side effects of KRYSTEXXA?

Please review important information section above. The most common side effects in patients taking KRYSTEXXA were gout flare-ups or attacks, allergic reactions, nausea, bruising, sore throat, constipation, chest pain, and vomiting.

This is not a complete list of all possible side effects. Tell your doctor or treatment team if you have any side effect that bothers you or that does not go away.

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