WARNING

Pegloticase is a medication used to treat chronic gout, a type of arthritis caused by the buildup of uric acid crystals in the joints. However, like any medication, pegloticase injection comes with potential risks and side effects. It’s crucial to consult with a healthcare professional for personalized information, but here are some general risks associated with pegloticase:

• Infusion Reactions: Some individuals may experience infusion reactions during or after receiving pegloticase. These reactions can include rash, flushing, nausea, headache, and difficulty breathing. In severe cases, anaphylaxis can occur, which is a life-threatening allergic reaction.
• Gout Flares: Initially, pegloticase treatment may trigger gout flares in some patients. This is because the medication breaks down uric acid crystals, releasing them into the bloodstream and potentially causing inflammation in the joints.
• Cardiovascular Events: There have been reports of cardiovascular events, such as heart attacks, in patients receiving pegloticase. It’s important to assess the cardiovascular risk in individuals before starting treatment.
• Hepatic (Liver) Effects: Pegloticase may have an impact on liver function, and monitoring liver enzymes is typically recommended during treatment.
• Hypersensitivity Reactions: Some individuals may develop hypersensitivity or allergic reactions to pegloticase, leading to various symptoms, including skin reactions, respiratory issues, and more.
• Infections: There is an increased risk of infections, including serious ones, in individuals receiving pegloticase. Patients should be monitored for signs of infection, and caution should be exercised in those with a history of recurrent infections.
• Renal (Kidney) Effects: Pegloticase can affect renal function, and monitoring kidney function is important during treatment.

It’s crucial for patients to discuss their medical history and any potential risk factors with their healthcare provider before starting pegloticase. Regular monitoring and communication with the healthcare team can help manage and mitigate potential risks associated with this medication.

Why is this medication prescribed?

Pegloticase is prescribed for the treatment of chronic gout in adults when other medications have not been effective or are not well-tolerated. Chronic gout is a form of arthritis caused by the accumulation of uric acid crystals in the joints, leading to inflammation, pain, and damage. Pegloticase works by converting uric acid into a substance that is more easily eliminated from the body, thereby reducing the levels of uric acid in the blood.

How should this medicine be used?

Here are general guidelines on how Pegloticase Injection is typically used:

• Administration: Pegloticase is given by intravenous (IV) infusion, usually every two weeks. The infusion is administered by a healthcare professional in a medical setting, such as a clinic or hospital.
• Dosage: The dosage of Pegloticase is determined by the healthcare provider based on individual factors, including the severity of gout and the patient’s overall health. It’s important to follow the prescribed dosage and schedule.
• Pre-treatment: To reduce the risk of infusion reactions, patients may be given medications such as antihistamines and corticosteroids before receiving Pegloticase. This pre-treatment helps minimize the likelihood of allergic reactions.
• Monitoring: Regular monitoring is essential during Pegloticase treatment. This includes checking for signs of infusion reactions, monitoring uric acid levels, assessing liver and kidney function, and watching for other potential side effects.
• Hydration: Adequate hydration is recommended to help prevent kidney-related issues. Patients are often advised to drink plenty of fluids before and after the infusion.

It’s crucial for patients to strictly follow their healthcare provider’s instructions and attend all scheduled appointments. Additionally, any concerns or side effects should be promptly reported to the healthcare team. Pegloticase is generally reserved for patients with severe, refractory gout, and its use is carefully monitored due to the potential risks associated with the medication. As with any prescription medication, individualized guidance from a healthcare professional is essential.

Other uses for this medicine

Pegloticase is primarily indicated for the treatment of chronic gout in adults who have not responded well to other therapies. It is not typically used for other medical conditions. Its mechanism of action involves converting uric acid into a more soluble form that can be excreted by the kidneys, helping to lower serum uric acid levels.

What special precautions should I follow?

Special precautions should be taken when using Pegloticase, and patients should discuss their medical history and potential risks with their healthcare provider. Here are some general precautions associated with Pegloticase:

• Hypersensitivity and Infusion Reactions: Pegloticase can cause infusion reactions, including hypersensitivity reactions. Patients should be monitored closely during and after infusion. Pre-treatment with antihistamines and corticosteroids may be recommended to reduce the risk of infusion reactions.
• Gout Flares: Patients may experience gout flares when starting Pegloticase due to the dissolution of uric acid crystals. Colchicine or nonsteroidal anti-inflammatory drugs (NSAIDs) may be prescribed to manage these flares.
• Cardiovascular Risk: There have been reports of cardiovascular events, including heart attacks, in patients receiving Pegloticase. Healthcare providers may assess cardiovascular risk before prescribing the medication.
• Infections: Patients on Pegloticase may have an increased risk of infections, including serious ones. It’s important to monitor for signs of infection, and caution should be exercised in those with a history of recurrent infections.
• Liver and Kidney Function: Pegloticase can affect liver and kidney function. Regular monitoring of liver enzymes and kidney function is recommended during treatment.
• Pregnancy and Breastfeeding: The safety of Pegloticase during pregnancy and breastfeeding is not well established. It should be used during pregnancy only if the potential benefits justify the potential risks to the fetus. Breastfeeding is not recommended during Pegloticase treatment.
• Interactions with Other Medications: Patients should inform their healthcare provider about all medications, including over-the-counter drugs and supplements, to avoid potential interactions with Pegloticase.

Patients should always follow their healthcare provider’s instructions regarding the use of Pegloticase, attend scheduled appointments, and report any unusual or severe side effects promptly. This information provides a general overview, and specific precautions may vary based on individual health conditions and medical history.

What special dietary instructions should I follow?

There are generally no specific dietary restrictions associated with Pegloticase. However, maintaining a healthy, balanced diet is essential for overall well-being. Adequate hydration is often recommended to help prevent kidney-related issues, so make sure to drink plenty of fluids unless otherwise advised by your healthcare provider.

What should I do if I forget a dose?

Pegloticase is typically administered in a healthcare setting by a professional, and patients do not administer it themselves. If you miss an appointment for your scheduled Pegloticase infusion, it’s important to contact your healthcare provider promptly to reschedule. Consistency in receiving the medication as prescribed is crucial for its effectiveness.

What side effects can this medication cause?

Pegloticase injection, like any medication, can cause side effects. It’s important to note that not everyone will experience these side effects, and the severity can vary. Common side effects of pegloticase include:

• Infusion Reactions: Some individuals may experience infusion reactions during or after receiving the medication. Symptoms can include flushing, rash, nausea, headache, and shortness of breath. In rare cases, severe allergic reactions (anaphylaxis) may occur.
• Gout Flares: At the beginning of treatment, there may be an increased risk of gout flares as uric acid crystals dissolve. This can lead to inflammation and pain in the joints.
• Hypersensitivity Reactions: Allergic reactions, including skin reactions, may occur. It’s important to promptly report any signs of allergic reactions to your healthcare provider.
• Cardiovascular Events: There have been reports of cardiovascular events, such as heart attacks, in patients receiving pegloticase. Individuals with a history of cardiovascular issues may be at an increased risk.
• Liver Function Abnormalities: Pegloticase can affect liver function, leading to increased liver enzyme levels. Regular monitoring of liver function is typically recommended.
• Kidney Function Abnormalities: Some individuals may experience changes in kidney function. Regular monitoring of kidney function is important during treatment.
• Infections: There is an increased risk of infections, including serious ones, in individuals receiving pegloticase. Patients should be monitored for signs of infection.
• Nausea and Vomiting: These gastrointestinal symptoms may occur as side effects of pegloticase.

It’s crucial to report any side effects or concerns to your healthcare provider promptly. The decision to use pegloticase is typically made after considering the potential benefits and risks in each individual case. The healthcare provider will closely monitor patients during treatment to manage and minimize potential side effects. Patients should also follow their healthcare provider’s recommendations for pre-treatment medications and other precautions to reduce the risk of infusion reactions.

What should I know about storage and disposal of this medication?

Storage and Disposal:

• Storage: Pegloticase is typically administered in a healthcare setting by a healthcare professional. However, if you have any unused portions of the medication at home, they should be stored as directed by your healthcare provider or pharmacist. Follow the specific storage instructions provided with the medication.
• Disposal: Unused or expired Pegloticase should be disposed of properly. Do not dispose of medications in wastewater or household waste unless instructed to do so. Consult with your healthcare provider or pharmacist regarding the proper disposal method.

In case of emergency/overdose

In the case of an emergency or overdose, seek immediate medical attention. The symptoms of an overdose or severe reaction may include severe allergic reactions, difficulty breathing, or other serious side effects. Call your local emergency services or go to the nearest emergency room.

What other information should I know?

• Follow-Up Appointments: Attend all scheduled follow-up appointments with your healthcare provider. Regular monitoring is essential to assess the effectiveness of the treatment and manage any potential side effects.
• Medical Alert: Inform all healthcare providers (including dentists and emergency medical personnel) about your Pegloticase treatment. Wear a medical alert bracelet or carry an identification card to notify others about your medication in case of emergency.
• Compliance: Adhere to your healthcare provider’s instructions regarding the administration of Pegloticase. It is usually administered by a healthcare professional in a clinical setting.
• Informing Healthcare Providers: Keep your healthcare provider informed about all medications, including prescription and over-the-counter drugs, as well as any supplements you are taking. This information is crucial to avoid potential drug interactions.
• Pregnancy and Breastfeeding: If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential risks and benefits of Pegloticase with your healthcare provider.
• Allergies: Inform your healthcare provider of any known allergies you have, including allergies to medications or other substances.

Always consult with your healthcare provider or pharmacist for specific and personalized guidance regarding the storage, disposal, and other important considerations related to Pegloticase Injection.