Side Effects

Nausea, vomiting, sore throat, or runny nose may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US –

In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Uses

Pegloticase is used to treat gout which has not responded to the usual treatments. It works by lowering high levels of uric acid in your body. Increased uric acid in your body can cause gout.

How to use Krystexxa Vial

Read the Medication Guide provided by your pharmacist before you start using pegloticase and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

If you are taking other medications (such as allopurinol, febuxostat) by mouth to lower the level of uric acid in your body, your doctor will direct you to stop the medication before starting and during treatment with pegloticase. Taking these drugs with pegloticase may lessen how well it works.

This medication is given by injection into a vein (over at least 2 hours) by a healthcare professional. It is usually given every 2 weeks.

Use this medication regularly in order to get the most benefit from it. Remember to receive it every 2 weeks. It may help to mark your calendar with a reminder.

You may experience more gout attacks for several months after starting this medicine while your body removes extra uric acid. Your doctor may prescribe additional medication (such as colchicine, nonsteroidal anti-inflammatory drugs-NSAIDs) to help prevent and treat these gout attacks.

Tell your doctor if your condition lasts or gets worse.

Warnings

Pegloticase may rarely cause a serious allergic reaction. This may occur during or after the infusion of the medication. Your doctor will check your blood before each treatment and monitor you closely during and after infusion. Your doctor should prescribe other medications (such as antihistamines, corticosteroids) to help prevent an allergic reaction. However, serious allergic reactions may still occur in a few patients. Get medical help right away if you develop any signs of an allergic reaction, such as rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, chest discomfort/pain.

Do not use this medication if you have a certain metabolic disorder called glucose-6-phosphate dehydrogenase (G6PD) deficiency because it can severely damage your red blood cells leading to anemia (hemolysis). If you are of African, Mediterranean, or Southern Asian descent, you may be at higher risk for G6PD deficiency and should be tested to see if you have this condition before starting this medication.

Precautions

Before receiving pegloticase, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: a certain metabolic disorder (G6PD deficiency), favism, heart failure.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Lab and/or medical tests (such as uric acid levels) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

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

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Do not take other medications (such as allopurinol, febuxostat) taken by mouth to lower the level of uric acid in your body before and during treatment with pegloticase. (