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Class: Antihyperuricemic (antigout) agent

Generic Name: Pegloticase

Trade Name: Krystexxa®

For which conditions is Krystexxa® approved for? Krystexxa is approved for use in adults to help reduce the signs and symptoms of gout that are not controlled by other treatments. Gout is a type of arthritis that occurs when uric acid builds up in blood and causes inflammation in the joints.

What is the mechanism of action? Krystexxa works by helping lower blood levels of uric acid and preventing uric acid from collecting in joints, kidneys, and other organs and causing inflammation.

How is Krystexxa typically given (administered)? Krystexxa is given by an infusion into a vein (intravenous infusion). Your doctor or a nurse will give you Krystexxa in a healthcare setting, where you can be treated if you have an allergic reaction. Treatment will take about two hours.

How are patients typically monitored? During treatment with Krystexxa, your doctor will watch you for signs of a serious allergic reaction (anaphylaxis). If a reaction occurs, it will likely be within two hours of the infusion. Your doctor will also check the uric acid levels in your blood to make sure levels aren’t increasing. In addition, you’ll be watched for flares in gout symptoms and infusion-site reactions, and patients with a history of congestive heart failure will have heart function monitored.

What are the common (occur in 30% or more of patients) side effects of treatment with Krystexxa?

  • Gout flare (Gout flares may increase during the first three months of treatment but should decrease after three months. Your doctor may give you other medicines to help reduce flares.)

What are the less common (occur in 10% to 29% of patients) side effects of treatment with Krystexxa?

  • Infusion reaction
  • Nausea

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

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Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

  • Keep a list of your medicines and show them to your doctor and pharmacist when you get a new medicine.
  • Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Are there any special precautions patients should be aware of before starting treatment?

  • If you have a rare blood problem called glucose 6­ phosphate dehydrogenase (G6PD) deficiency or favism, you should not receive Krystexxa. Your doctor may test you for G6PD before you start treatment.
  • Do not take any other uric acid lowering drug, such as allopurinol or Uloric® (febuxostat), during treatment with Krystexxa.

Before you receive KRYSTEXXA, tell your doctor if you:

  • Know you have G6PD deficiency.
  • Have ever had any type of heart problem or high blood pressure.
  • Are pregnant or plan 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. You and your doctor should decide if you will receive Krystexxa or breastfeed—you should not do both.

When should patients notify their physician?

Tell your doctor or nurse right away if you have any of these symptoms of an allergic reaction 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

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.