Pegloticase (peg-LOE-ti-kase)

Treats chronic gout.

Brand Name(s):

Krystexxa

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein. This medicine is usually given every 2 weeks.
• A nurse or other health provider will give you this medicine.
• This medicine must be given slowly, so the needle will stay in place for 2 hours or longer.
• Your doctor may also give you methotrexate and folic acid or folinic acid supplements at least 4 weeks before starting and during treatment with this medicine.
• You may also receive medicines (including antihistamines, corticosteroids) to help prevent possible allergic reactions to the injection.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: You must use this medicine on a fixed schedule. Call your doctor or pharmacist if you miss a dose.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how pegloticase works. Tell your doctor if you are using methotrexate or other medicines to lower uric acid levels, including allopurinol or febuxostat.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have congestive heart failure or favism.
• Tell your doctor if you have relatives from Africa, Southern Asia, or a Mediterranean country. People with relatives from these areas are more likely to have a genetic G6PD deficiency.
• Gout flares may occur in the first 3 months after you start receiving this medicine. Do not stop receiving this medicine even if you have a gout flare. Your doctor may give you medicines to reduce and prevent worsening of gout.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain or uneven heartbeat, trouble breathing
• Swelling in your hands, ankles, or feet
• Warmth or redness in your face, neck, arms, or upper chest
• Worsening symptoms of gout, joint pain

If you notice these less serious side effects, talk with your doctor:

• Bruises or purplish patches on the skin
• Constipation, nausea, vomiting
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed
• Runny or stuffy nose, sore throat

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088