Generic Name: pegloticase (peg-LOE-ti-kase)
Brand Name: Krystexxa
Serious, life-threatening allergic reactions may occur in some people who receive Krystexxa. These reactions usually occur within 2 hours after receiving Krystexxa, but can occur at any time during or after you receive Krystexxa. Tell your doctor or nurse immediately if you experience any of the following symptoms: dizziness; fainting; fast or weak heartbeat; nervousness; rash; hives; itching; chest pain or tightness; cough; shortness of breath; trouble breathing or swallowing; wheezing; swelling of the mouth, face, lips, tongue, or throat; unusual hoarseness.
Krystexxa is given in a doctor's office, hospital, or clinic where serious allergic reactions can be treated if one occurs. Your health care provider will watch you for any signs of a serious allergic reaction during and after your treatment with Krystexxa. Your doctor will prescribe other medicines to help decrease the risk of an allergic reaction or infusion-related side effects.
Lab tests, including blood uric acid levels, will be monitored before and while you use Krystexxa. Contact your doctor if you have any questions or concerns about this information.
Krystexxa is used for:
Treating chronic gout in certain patients.
Krystexxa is a uric acid-specific enzyme (uricase). It works by allowing uric acid to be more easily removed from the body by the kidneys.
Do NOT use Krystexxa if:
- you are allergic to any ingredient in Krystexxa
- you have high blood uric acid levels without symptoms
- you have a metabolic condition called glucose 6-phosphate dehydrogenase (G6PD) deficiency or favism
- you are taking other medicines to lower blood uric acid levels (eg, allopurinol, febuxostat)
Contact your doctor or health care provider right away if any of these apply to you.
Before using Krystexxa:
Some medical conditions may interact with Krystexxa. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you are of African or Mediterranean ancestry
- if you have a history of heart problems (eg, congestive heart failure [CHF]) or high blood pressure
- if you have received Krystexxa before
Some MEDICINES MAY INTERACT with Krystexxa. Tell your health care provider if you are taking any other medicines. However, no specific interactions with Krystexxa are known at this time.
Ask your health care provider if Krystexxa may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Krystexxa:
Use Krystexxa as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Krystexxa comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Krystexxa refilled.
- Krystexxa is usually given as an injection at your doctor's office, hospital, or clinic.
- You may receive certain other medicines, including an antihistamine (eg, diphenhydramine) and a corticosteroid (eg, prednisone), before each treatment with Krystexxa. This will help to decrease the chance of an allergic reaction to Krystexxa. Discuss any questions with your doctor.
- Do not use Krystexxa if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- If you miss a dose of Krystexxa, contact your doctor immediately to establish a new dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Krystexxa.
Important safety information:
- Patients with a metabolic condition called G6PD deficiency should not use Krystexxa because it can severely damage your red blood cells (hemolysis), leading to anemia. It may also cause a condition that affects the ability of your red blood cells to carry oxygen (methemoglobinemia). If you are of African or Mediterranean descent, you may be at higher risk of G6PD deficiency and should be tested to see if you have this condition before starting Krystexxa. Contact your doctor with any questions or concerns.
- Gout flares may increase in the first 3 months after you start taking Krystexxa. Do not stop taking Krystexxa if you develop increased gout flares. Your doctor may prescribe certain other medicines (eg, a nonsteroidal anti-inflammatory drug [NSAID] [eg, ibuprofen], colchicine) to decrease the risk of gout flares. Contact your doctor with any questions or concerns.
- Lab tests, including uric acid levels, may be performed while you use Krystexxa. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Krystexxa should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: It is not known if Krystexxa can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Krystexxa while you are pregnant. It is not known if Krystexxa is found in breast milk. Do not breast-feed while taking Krystexxa.
Possible side effects of Krystexxa:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Bruising; constipation; mild sore throat or nose irritation; nausea; vomiting.
Severe allergic reactions (rash; hives; itching; chest pain or tightness; trouble breathing or swallowing; wheezing; swelling of the mouth, face, lips, tongue, or throat; or unusual hoarseness); cough; dizziness; fainting; fast or irregular heartbeat; nervousness; persistent or worsening joint pain or swelling; reddening of the face or feeling warm; shortness of breath; sudden, unexplained weight gain; swelling of the hands, ankles, legs, or feet.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Krystexxa:
Krystexxa is usually handled and stored by a health care provider. If you are using Krystexxa at home, store Krystexxa as directed by your pharmacist or health care provider. Keep Krystexxa out of the reach of children and away from pets.
- If you have any questions about Krystexxa, please talk with your doctor, pharmacist, or other health care provider.
- Krystexxa is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Krystexxa or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Krystexxa. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Krystexxa. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Krystexxa.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.