Pegloticase

Pegloticase is a prescription medication used to prevent gout attacks in people who have not responded to other gout treatments or cannot tolerate them.  Pegloticase belongs to a group of drugs called PEGylated uric acid specific enzymes. It works by decreasing the amount of uric acid in the body. 

This medication comes in a solution (liquid) to be given directly into a vein (IV) by a healthcare provider in a medical setting. Pegloticase is usually given once every 2 weeks.

Common side effects of pegloticase include gout attacks, infusion reaction (hives, shortness of breath, and itching), and nausea.

Pegloticase is a prescription medication used to treat chronic (long-lasting) gout in adults for whom other medications have not worked or have caused intolerable side effects.

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

Pegloticase may be found in some form under the following brand names:

• Krystexxa

Common side effects include:

• gout attack
• infusion reaction
• nausea
• vomiting
• constipation
• bruising
• chest pain

This is not a complete list of pegloticase side effects. Ask your doctor or pharmacist for more information.

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

No pegloticase drug interactions have been studied by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with pegloticase including the following:

• serious allergic reactions. Serious allergic reactions may occur in some people taking pegloticase. These allergic reactions can be life-threatening and usually happen within 2 hours of the infusion. Your doctor or nurse will watch for any signs of a serious allergic reaction during and after your treatment with pegloticase. Tell your doctor or nurse right away if you experience wheezing, shortness of breath, cough, chest tightness, chest pain, or trouble breathing. It is also important to let your doctor know if you experience reddening of the face, itching, hives, swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing.

Pegloticase can cause dizziness. Do not drive or operate heavy machinery until you know how pegloticase affects you.

Do not take pegloticase if you:

• are allergic to pegloticase or to any of its ingredients
• have glucose-6-phosphate dehydrogenase (G6PD) deficiency (genetic disorder that can affect the red blood cells)

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of pegloticase, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking pegloticase, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to pegloticase or to any of its ingredients
• know you have a rare blood problem called glucose-6-phosphate dehydrogenase (G6PD) deficiency
• ever had any heart problems or high blood pressure
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories-A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Pegloticase falls into category C. There are no well-controlled studies that have been done in pregnant women. Pegloticase should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if pegloticase crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with the use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using pegloticase.

Take pegloticase exactly as prescribed.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dose of pegloticase is 8 mg given directly into a vein every 2 weeks.

If pegloticase is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

You may receive medications before receiving pegloticase to prevent side effects from the injection.

WARNING: ANAPHYLAXIS AND INFUSION REACTIONS

• Anaphylaxis and infusion reactions have been reported to occur during and after administration of pegloticase.
• Anaphylaxis may occur with any infusion, including a first infusion, and generally manifests within 2 hours of the infusion. However, delayed-type hypersensitivity reactions have also been reported.
• Pegloticase should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions.
• Patients should be premedicated with antihistamines and corticosteroids.
• Patients should be closely monitored for an appropriate period of time for anaphylaxis after administration of pegloticase.
• Monitor serum uric acid levels prior to infusions and consider discontinuing treatment if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed.