Glossary

Colchicine (kol'-chi-sen) ─ a compound extracted from the autumn crocus plant, used in the treatment of gout and acute attacks of gouty arthritis.

Congestive heart failure (kuh n-jest-iv hart fāl'yɘr) ─ heart failure in which the heart is unable to maintain enough circulation of blood and oxygen in the tissues of the body. It can also happen when the heart is unable to pump out blood from the heart to the lungs to get more oxygen. When patients have heart failure, there can be swelling of the feet and ankles, shortness of breath, and an enlarged heart.

Enzyme (ĕn'zīm) ─ a complex protein produced by living cells that helps certain chemical reactions to occur in the body.

G6PD deficiency ─ Shorthand for glucose-6-phosphate dehydrogenase, G6PD deficiency is a genetic condition that causes red blood cells to break down—in certain situations or with certain foods or medicines—which can lead to anemia (low blood count). G6PD deficiency occurs mostly in people of Mediterranean or African background but can occur in anyone. A simple blood test can test you for this condition.

This genetic deficiency occurs especially in people of Mediterranean or African family background but can occur in anyone. A simple blood test can be used to find out if a person has this condition.

Gout attack, gout flare, or flare-up ─ sudden and painful inflammation, redness, and swelling in and around the joints. Flare-ups are caused by inflammation in the presence of uric acid crystals.

Gouty arthritis ─ arthritis associated with gout and caused by the deposit of uric crystals in and around the joints.

Hyperuricemia (high-per-yoo r-uh-see-mee-uh) ─ excess uric acid in the blood as seen in gout. The higher the level of uric acid and the longer the level is abnormal, the greater the risk of developing gout and its complications.

Important lab value: A measurement of a substance found in a bodily fluid, such as blood.

Infusion reaction (in-fyoo-zhuh n ree-ak-shuh n) ─ a side effect that can occur when certain medicines, including KRYSTEXXA (pegloticase) are given in the vein during an infusion (see below). With KRYSTEXXA®, this side effect can occur during or within 2 hours after the infusion. Infusion reactions can have one or more of these symptoms: wheezing, shortness of breath, coughing, chest tightness, chest pain, trouble breathing, dizziness, fainting, change in heartbeat, feeling nervous, facial redness, itching, hives, feeling warm, swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing.

Intravenous (IV) infusion (in-trɘ-vē-nɘs in-fyoo-zhuh n) ─ introduction of a solution (such as sugar water or salt water), with or without medicine, into a vein. IV infusions are usually performed in a doctor's office, hospital, or at an infusion center.

Metabolism (me-tab-o-lism) ─ the process by which the body breaks down the substances that you eat and drink.

Refractory (ri-frak-tuh-ree) ─ resistant to or not responsive to treatment.

Refractory chronic gout (ri-frak-tuh-ree kron-ik-gout) ─ gout marked by long duration, by frequent recurrence over a long time, and often by slowly progressing seriousness; gout is resistant to or not responsive to treatment; patients with chronic gout have signs and symptoms that have existed over a long period of time and are almost always present (tophi or painful arthritis) or occur frequently (gout flare-ups).

Serious allergic reaction ─ extreme sensitivity to a protein or medicine that can cause a severe reaction in a susceptible individual.

Tophi (toh-fī-) ─ deposits of uric acid crystals in tissues characteristic of gout (plural form of tophus).

Uric acid (yoo r-ik-as-id) ─ a chemical produced by the body from the breakdown of cells and certain types of food, especially certain foods rich in protein.

Uricase (yur-i-kās) ─ an enzyme that breaks down uric acid. It is found in most animals, but is not found in humans. KRYSTEXXA is a manufactured version of an enzyme found in nature.





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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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