Pegloticase Solution for injection

What is this medicine?

PEGLOTICASE (peg LOE ti kase) is an enzyme used to treat chronic gout.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• G6PD deficiency

• heart disease

• an unusual or allergic reaction to pegloticase, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting.

A special MedGuide will be given to you before each treatment. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

• certain medicines for gout like allopurinol, febuxostat, probenecid, sulfinpyrazone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

This medicine can cause serious allergic reactions. To reduce your risk you may need to take medicine before treatment with this medicine. Take your medicine as directed.

Your condition will be monitored carefully while you are receiving this medicine.

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse. You will need simple blood tests.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• chest pain or chest tightness

• fast or irregular heartbeat

• feeling faint or lightheaded, falls

• pain when urinating

• swelling of the ankles, feet, hands

• symptoms of gout

• unusual bleeding or bruising

• unusually weak or tired

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• muscle pain

• nausea, vomiting

• upset stomach

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.