When This Medicine Should Not Be Used:
This medicine is not right for everyone. You should not receive it if you had an allergic reaction to pegloticase or if you have glucose-6-phosphate dehydrogenase (G6PD) deficiency or favism.

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.
• 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.

• Tell your doctor if you use other medicines to lower uric acid levels, such as allopurinol or febuxostat.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding or if you have congestive heart failure.
• Tell your doctor if you have relatives from Africa 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 irregular 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

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

• Bruises or purplish patches on the skin
• Nausea or vomiting
• Stuffy or runny 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