Pegloticase (Injection)

Introduction

Pegloticase (peg-LOE-ti-kase)

Treats chronic gout in patients who have already been treated with other medicines that did not work well.

Brand Name(s)

Krystexxa

When This Medicine Should Not Be Used

How to Use This Medicine

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given through a needle placed in one of your veins. This medicine is usually given every 2 weeks.
• A nurse or other trained health professional will give you this medicine.
• This medicine must be given slowly, so the needle will remain in place for a few hours (up to 2 hours or longer). You may also receive medicines (such as antihistamines, corticosteroids) to help prevent possible allergic reactions to the injection.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

If a dose is missed:

• This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have congestive heart failure, heart problems, or high blood pressure.
• This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; hives; itching; dizziness; shortness of breath; swelling of your hands, face, mouth, or tongue; trouble with breathing or swallowing; or chest pain after you receive the medicine.
• This medicine may cause infusion reactions, such as a rash, itching, or redness of the skin; difficulty with breathing; feeling of warmth or redness of the face, neck, arms and occasionally, upper chest; or chest discomfort or pain, while you are receiving the injection or within 2 hours after you receive it. Stop using this medicine and check with your doctor or nurse right away if you have any of these symptoms.
• Tell your doctor if you are of African or Mediterranean descent, because people with this ancestry are more likely to have G6PD deficiency.
• Gout flares may occur in the first three months when you start receiving this medicine. Do not stop receiving this medicine even if you have a gout flare. Your doctor may give you medicines (such as colchicine, non-steroidal antiinflammatory drug or NSAID) to reduce and prevent worsening of the gout.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. Blood tests may be needed to check for unwanted effects.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain.
• Shortness of breath, cold sweat, and bluish-colored skin.
• Swelling in your hands, ankles, or feet.
• Troubled breathing.
• Warmth or redness in your face, neck, arms, or upper chest.
• Worsening symptoms of gout (such as ankle, knee, or great toe joint pain, stiffness, or swelling).

If you notice these less serious side effects, talk with your doctor:

• Bruise or purplish patches in the skin.
• Constipation, nausea, or vomiting.
• Stuffy or runny nose, sore throat.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088