Pegloticase, Infusion

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KEY POINTS

• This medicine is given by IV to treat gout.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause infusion reactions, a life-threatening allergic reaction, or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: PEGylated uric acid specific enzyme

Generic and brand names: pegloticase, infusion; Krystexxa

What is this medicine used for?

This medicine is given by IV infusion to treat gout when other medicines have not worked well.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• G6PD deficiency, or if you are of African, Southern European, Middle Eastern, or Southern Asian ancestry
• Heart failure
• High blood pressure

Also, tell your healthcare provider if you have ever been treated with this medicine before.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Read the Medication Guide when you start receiving this medicine and each time you get an infusion.

This medicine is given by IV infusion (slow drip through a needle into a large vein) by your healthcare provider. Keep all appointments for these infusions. If you miss an appointment for an infusion, call your healthcare provider right away to reschedule.

You may be given a medicine before you receive this medicine to help reduce the chance of an allergic reaction. You will be monitored closely while receiving this medicine and for some time after receiving this medicine. If you have side effects, your healthcare provider may stop or slow the infusion and may give you medicine to help the side effects.

Take all medicines as instructed by your healthcare provider.

What should I watch out for?

This medicine may cause a serious, life-threatening, allergic reaction called anaphylaxis. It is only given where you can be monitored closely. This reaction may happen with any infusion and usually within 2 hours of an infusion. However, delayed reactions may also happen. Tell your healthcare provider immediately if you have a rash, hives, itching, dizziness, fainting, fast or slow heartbeat, trouble breathing, cough, chest pain or chest tightness, trouble swallowing, hoarse voice, or swelling of your lips, tongue, or throat.

This medicine may also cause an infusion reaction with symptoms such as rash or redness of the skin, chest discomfort, shortness of breath, itching, or feeling warm. Contact your healthcare provider immediately if you have any of these symptoms while receiving this medicine or after you have received this medicine.

This medicine may increase gout flares when you first start taking it. The gout flares should decrease after a few months. Your healthcare provider may prescribe other medicines to help reduce your gout flares for the first few months after starting this medicine. Talk with your provider about this.

You may need to have blood tests regularly to see how this medicine affects you. Keep all appointments.

Your healthcare provider may stop this medicine if your uric acid levels do not become normal and stay controlled or you have certain side effects. Talk with your healthcare provider about this.

Follow the diet program your healthcare provider recommends. Certain food or drinks may cause gout attacks. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat); trouble swallowing, hoarse voice, unexplained cough, chest pain, fast or slow heartbeat, dizziness or fainting.

Serious (Report these to your healthcare provider right away.): Rash or redness of the skin, feeling warm.

Other: Gout flares, nausea, vomiting, constipation, sore throat, bruising.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Other gout medicines such as allopurinol (Aloprim, Zyloprim), febuxostat (Uloric), and probenecid

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.