Pegloticase

Pegloticase is used to treat chronic gout. Pegloticase is usually given after other gout medications have been tried without successfully treating symptoms.

Pegloticase may also be used for reasons not mentioned in this medication guide.

Pegloticase is given as an infusion into a vein, usually once every 2 weeks. A healthcare provider will give you this injection.

This medicine must be given slowly, and the infusion can take at least 2 hours to complete.

You may be given other medications to help prevent serious side effects or an allergic reaction. Your doctor may also recommend other gout medications to use during the first 6 months of treatment with pegloticase. Keep using all medicines for as long as your doctor has prescribed.

When you first start using pegloticase, you may have more gout flares.

Your doctor will need to check your progress regularly.

Tell your doctor if your symptoms do not improve after 3 months of treatment.

Tell your doctor about all the medicines you are currently taking and any that you start or stop. Many drugs can interact, and some should not be used together.

Inform your caregivers immediately if you feel itchy, light-headed, short of breath, or experience chest discomfort or skin redness during the injection.

You should not use pegloticase if you are allergic to it, or if you have a genetic enzyme deficiency called glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Some medicines can cause unwanted or dangerous effects when used with pegloticase. Your doctor may change your treatment plan if you also use:

• allopurinol (Zyloprim); or
• febuxostat (Uloric).

Tell your doctor if you have ever had:

• heart problems; or
• high blood pressure.

It is not known whether pegloticase will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Some side effects may happen during the injection. Tell your caregiver if you feel nervous, light-headed, itchy, short of breath, or have fast heartbeats, chest discomfort, or redness of your skin during the injection.

Pegloticase may cause serious side effects. Call your doctor right away if you have:

• chest pain; or
• flushing (warmth, redness, or tingly feeling).

Common side effects of pegloticase may include:

• COVID-19 symptoms such as fever or chills, cough, sore throat, shortness of breath, fatigue, muscle or body aches, headache, loss of taste or smell;
• hives, shortness of breath, chest pain or discomfort, skin redness, or itching;
• joint pain;
• allergic reactions;
• new gout flares;
• nausea, vomiting, constipation; or
• bruising.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Gout:

8 mg via IV infusion every 2 weeksComment:-Must be given via IV infusion (over no less than 120 minutes); do not administer IV push or bolus. -Premedications (e.g., antihistamines, corticosteroids) are recommended to minimize the risk of anaphylaxis and infusion reactions.-This drug is not recommended for the treatment of asymptomatic hyperuricemia. -The optimal duration of treatment has not been established. Use: For the treatment of chronic gout in patients who are refractory to conventional therapy (e.g., patients who have failed to normalize serum uric acid and whose signs/symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated)

Call your doctor for instructions if you miss an appointment for your Pegloticase injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Other drugs may affect pegloticase, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.