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Pegloticase

Warning

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

See also Warning section.

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 breastfeeding.

Side Effects

See also Warning section.

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 -

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.