Pegloticase Injection

IMPORTANT WARNING:

Pegloticase injection may cause serious or life-threatening reactions. These reactions are most common within 2 hours of receiving the infusion but may occur at any time during treatment. The infusion should be given by a doctor or nurse in a healthcare setting where these reactions can be treated. You also may receive certain medications before your infusion of pegloticase to help to prevent a reaction. Your doctor or nurse will watch you carefully while you receive pegloticase injection and for some time afterwards. Tell your doctor if you experience any of the following symptoms during or after your infusion: difficulty swallowing or breathing; wheezing; hoarseness; swelling of the face, throat, tongue or lips; hives; sudden redness of the face, neck or upper chest; rash; itching; redness of the skin; fainting; dizziness; chest pain; or tightness of the chest. If you experience a reaction, your doctor may slow or stop the infusion.

Pegloticase injection may cause serious blood problems. Tell your doctor if you have glucose-6-phosphate dehydrogenase (G6PD) deficiency (an inherited blood disease). Your doctor may test you for G6PD deficiency before you start to receive pegloticase injection. If you have G6PD deficiency, your doctor will probably tell you that you cannot receive pegloticase injection. Also tell your doctor if you are of African, Mediterranean (including Southern European and Middle Eastern), or Southern Asian descent.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to pegloticase injection and may stop your treatment if the medication is not working.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with pegloticase injection and each time you receive the medication. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

WHY is this medicine prescribed?

Pegloticase injection is used alone or in combination with methotrexate (Trexall, Xatmep) and folic acid to treat chronic gout (sudden, severe pain, redness, and swelling in one or more joints caused by abnormally high levels of a substance called uric acid in the blood) in adults who cannot take or did not respond to other medications. Pegloticase injection is in a class of medications called PEGylated uric acid specific enzymes. It works by decreasing the amount of uric acid in the body. Pegloticase injection is used to prevent gout attacks but not to treat them once they occur.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Pegloticase injection comes as a solution (liquid) to be injected intravenously (into a vein) by a doctor or nurse in a medical office or clinic. It is usually given once every 2 weeks. It will take at least 2 hours for you to receive your dose of pegloticase injection.

It may take several months before pegloticase injection begins to prevent gout attacks. Pegloticase injection may increase the number of gout attacks during the first 3 months of your treatment. Your doctor may prescribe another medication such as colchicine or a nonsteroidal anti-inflammatory drug (NSAID) to prevent gout attacks during the first six months of your treatment. Continue to receive pegloticase injection even if you have gout attacks during your treatment.

Pegloticase injection controls gout but does not cure it. Continue to receive pegloticase injections even if you feel well. Do not stop receiving pegloticase injections without talking to your doctor.

What SPECIAL PRECAUTIONS should I follow?

Before receiving pegloticase injection,

• tell your doctor and pharmacist if you are allergic to pegloticase, any other medications, or any of the ingredients in pegloticase injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor if you are taking allopurinol (Aloprim, Lopurin, Zyloprim), febuxostat (Uloric), or probenicid (Probalan). Your doctor will probably tell you not to receive pegloticase injection if you are taking one or more of these medications.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had heart failure, high blood pressure, or heart disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using pegloticase injection, call your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Pegloticase injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• constipation
• bruising
• sore throat
• joint pain
• fatigue

Pegloticase injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Ask your pharmacist any questions you have about pegloticase injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.