IMPORTANT SAFETY INFORMATION
What is the most important information I should know about Krystexxa® (pegloticase)?
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. However, delayed-type hypersensitivity reactions have also been reported.
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.
Before starting Krystexxa, you should know that:
Krystexxa is a prescription medicine for adults who have tried or cannot take oral gout medicines and still have high uric acid levels and gout signs and symptoms, also known as chronic refractory gout.
Krystexxa is not recommended if you have high levels of uric acid without gout.
It is not known if Krystexxa is safe and effective in children.
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. Patients at a higher risk should be screened due to potential blood disorder complications.
Before you receive Krystexxa, tell your doctor if you:
- Know you have G6PD deficiency
- Have previously received Krystexxa
- Have, or ever had, heart problems (including heart failure) 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
- Are taking any other uric acid lowering drug
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
There are possible side effects with Krystexxa:
Please review important information section above. The most common serious side effects in patients taking Krystexxa were gout flare-ups or attacks, 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 (e.g. Krystexxa) to lower their uric acid levels. Patients do not need to stop taking Krystexxa simply because of gout flares. Your doctor may give you other medicines to help reduce your gout flares for the first few months after starting Krystexxa.
Your doctor may stop your Krystexxa if your uric acid levels do not become normal and stay controlled or you have certain side effects.
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.
Ask your doctor or treatment team if you have any questions or want 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.