Important Safety Information

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-10881-800-FDA-1088.

USE and IMPORTANT SAFETY INFORMATION

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.

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.

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-10881-800-FDA-1088.