WARNING

Krystexxa (generic name: pegloticase) is a medication used to treat a condition called chronic gout, particularly when it has not responded to other treatments. While Krystexxa can be effective, it also carries certain risks and potential side effects. Here are some of the risks associated with taking Krystexxa:

• Infusion reactions: Infusion reactions are the most common adverse events associated with Krystexxa. They can include symptoms such as flushing, rash, itching, dizziness, difficulty breathing, and changes in blood pressure. These reactions can be severe in some cases and may require medical attention.
• Gout flares: Initially, Krystexxa treatment can trigger gout flares. This is because the medication helps to break down uric acid, which can cause uric acid crystals to dissolve and release into the bloodstream. This sudden release can temporarily worsen gout symptoms before they improve.
• Cardiovascular risks: Some studies have suggested a potential increased risk of cardiovascular events, such as heart attack and stroke, in patients receiving Krystexxa. However, further research is needed to fully understand this association.
• Anaphylaxis: Although rare, severe allergic reactions, including anaphylaxis, have been reported in patients receiving Krystexxa. Anaphylaxis is a life-threatening reaction that requires immediate medical attention.
• Other side effects: Other common side effects of Krystexxa may include nausea, bruising, sore throat, back pain, and high blood pressure. It’s important to discuss any new or persistent side effects with your healthcare provider.

It’s crucial to note that the risks and benefits of Krystexxa should be assessed on an individual basis, considering the severity of the condition and other medical factors. It’s essential to consult with a healthcare professional who can evaluate your specific situation and guide you through the treatment process.

Why is this medication prescribed?

Krystexxa (generic name: pegloticase) is prescribed to treat a medical condition called chronic gout, particularly when it has not responded to other treatments or when there are contraindications to other medications. Gout is a form of arthritis that occurs when there is a buildup of uric acid crystals in the joints, leading to intense pain, inflammation, and swelling.

Krystexxa is an enzyme replacement therapy that works by converting uric acid into a compound called allantoin, which is easily excreted by the body. By reducing the levels of uric acid in the bloodstream, Krystexxa aims to dissolve the uric acid crystals that have formed in the joints and alleviate the symptoms of gout.

Chronic gout can be a debilitating condition that significantly affects a person’s quality of life. When other medications, such as nonsteroidal anti-inflammatory drugs (NSAIDs) or urate-lowering therapies, have failed to adequately control gout symptoms, Krystexxa may be considered as an alternative treatment option.

It’s important to note that Krystexxa is usually reserved for patients who have severe and uncontrolled gout, as it carries certain risks and potential side effects. The decision to prescribe Krystexxa should be made by a healthcare professional after a careful evaluation of the individual’s medical history, the severity of the gout, and other treatment options available.

How should this medicine be used?

Krystexxa (generic name: pegloticase) is administered as an intravenous (IV) infusion by a healthcare professional. It is typically given every two weeks. Here’s a general overview of how Krystexxa should be used:

• Administration: Krystexxa is administered by a healthcare provider in a medical setting, such as a clinic or hospital. The medication is given through a needle inserted into a vein.
• Dosage: The recommended dosage of Krystexxa is 8 milligrams (mg) per kilogram (kg) of body weight. The maximum dose per infusion is 12 mg/kg. The specific dosage and infusion schedule may vary depending on individual factors, so it’s important to follow your healthcare provider’s instructions.
• Pre-medication: Prior to each infusion of Krystexxa, your healthcare provider may prescribe medications to help prevent or manage potential infusion reactions. These medications may include antihistamines and corticosteroids. It’s crucial to take these pre-medications as directed.
• Infusion duration: The duration of the Krystexxa infusion can vary but typically takes about two hours. During the infusion, you will be monitored for any signs of infusion reactions or other adverse effects.
• Follow-up appointments: Regular follow-up appointments with your healthcare provider will be necessary to assess the response to treatment and adjust the dosage if needed. It’s important to attend these appointments and discuss any concerns or side effects you may experience.

It’s essential to strictly adhere to the prescribed dosage and infusion schedule for Krystexxa. If you have any questions or concerns regarding the administration or usage of Krystexxa, it is best to consult your healthcare provider, who can provide personalized guidance based on your specific condition.

Other uses for this medicine

Krystexxa (generic name: pegloticase) is primarily approved and used for the treatment of chronic gout in patients who have not responded to other therapies. However, it is important to note that medications are often prescribed off-label for conditions other than their approved indications. While Krystexxa is primarily used for chronic gout, its use in other conditions is limited, and the safety and effectiveness for those purposes may not be well-established. Therefore, it is crucial to consult with a healthcare professional to understand the appropriate uses of Krystexxa for your specific medical condition.

What special precautions should I follow?

Regarding special precautions, there are several important considerations to be aware of when using Krystexxa:

• Allergic reactions: Krystexxa can potentially cause severe allergic reactions, including anaphylaxis. It is important to inform your healthcare provider about any known allergies or history of allergic reactions before starting treatment.
• Infusion reactions: Infusion reactions, such as flushing, rash, itching, dizziness, difficulty breathing, and changes in blood pressure, are common with Krystexxa. These reactions can be severe in some cases. Close monitoring during the infusion is necessary, and healthcare providers may administer pre-medications to reduce the risk of infusion reactions.
• Gout flares: When starting Krystexxa, there is a risk of gout flares as uric acid crystals dissolve. To mitigate this risk, healthcare providers may prescribe medications such as colchicine or NSAIDs before initiating Krystexxa treatment.
• Cardiovascular risks: Some studies have suggested a potential increased risk of cardiovascular events, such as heart attack and stroke, in patients receiving Krystexxa. Further research is needed to fully understand this association.
• Contraindications: Krystexxa should not be used in patients with a glucose-6-phosphate dehydrogenase (G6PD) deficiency or a history of hemolytic anemia. It should also be used with caution in patients with congestive heart failure.
• Drug interactions: Krystexxa may interact with certain medications. It is important to inform your healthcare provider about all medications, including over-the-counter drugs and supplements, that you are currently taking.

It is crucial to have a thorough discussion with your healthcare provider about the potential risks, benefits, and precautions associated with Krystexxa before starting treatment. Your healthcare provider will consider your individual medical history and circumstances to determine if Krystexxa is appropriate for you and how to best manage any potential risks.

What special dietary instructions should I follow?

There are no specific dietary instructions associated with Krystexxa (pegloticase) that need to be followed. However, it is important to maintain a healthy and balanced diet as part of overall gout management. A diet low in purines, which are found in certain foods, can help reduce uric acid levels and minimize gout symptoms. Some purine-rich foods to limit include organ meats, shellfish, red meat, and high-fructose corn syrup. It’s advisable to consult with a healthcare professional or a registered dietitian for personalized dietary recommendations based on your specific condition and needs.

What should I do if I forget a dose?

If you happen to miss a dose of Krystexxa, it is crucial to contact your healthcare provider as soon as possible. They can provide guidance on how to proceed and whether a makeup infusion is necessary. It is not recommended to make any changes to your dosing schedule or take extra doses without consulting a healthcare professional. Adhering to the prescribed treatment plan is essential for the effectiveness of Krystexxa and the management of chronic gout.

What side effects can this medication cause?

Krystexxa (generic name: pegloticase) can cause several side effects, some of which may require medical attention. It’s important to note that not all individuals will experience these side effects, and their severity can vary. Common side effects of Krystexxa may include:

• Infusion reactions: Infusion reactions are the most common adverse events associated with Krystexxa. They can include symptoms such as flushing, rash, itching, dizziness, difficulty breathing, and changes in blood pressure. These reactions can be severe in some cases and may require immediate medical attention.
• Gout flares: When initiating Krystexxa treatment, gout flares can occur as a result of the dissolution of uric acid crystals. This temporary worsening of gout symptoms typically resolves over time with continued treatment.
• Nausea: Some individuals may experience nausea after receiving Krystexxa infusions. This side effect is generally mild and transient.
• Bruising: Krystexxa infusions can occasionally cause bruising at the injection site. This is usually a minor side effect and resolves on its own.
• Sore throat: A sore throat is another reported side effect of Krystexxa treatment. If this symptom persists or worsens, it’s advisable to inform your healthcare provider.
• Back pain: Back pain has been observed in some individuals receiving Krystexxa. If back pain becomes severe or persistent, it should be reported to your healthcare provider.
• High blood pressure: In some cases, Krystexxa treatment has been associated with an increase in blood pressure. Regular monitoring of blood pressure is typically conducted during treatment.

It is important to promptly report any new or concerning side effects to your healthcare provider. They can assess your symptoms, provide appropriate advice, and determine whether any adjustments to your treatment plan are necessary.

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

• Storage: Krystexxa should be stored in a refrigerator between 2°C to 8°C (36°F to 46°F). It should be kept in its original packaging to protect it from light. Do not freeze the medication.
• Disposal: It is advisable to consult with your healthcare provider or local regulations regarding the proper disposal of unused or expired Krystexxa. They can provide guidance on safe disposal methods, such as returning it to a pharmacy or following local guidelines for medication disposal.

In case of emergency/overdose

In case of emergency or suspected overdose, it is important to seek immediate medical assistance. Contact your local emergency services or go to the nearest emergency room. It can be helpful to bring the medication packaging or provide information about the medication ingested.

What other information should I know?

Here are some additional points to consider:

• Monitoring: Regular monitoring of uric acid levels and gout symptoms will be conducted by your healthcare provider during Krystexxa treatment. This allows them to assess the effectiveness of the medication and make any necessary adjustments to your treatment plan.
• Compliance: It is important to adhere to the prescribed treatment schedule and not miss any doses of Krystexxa. Skipping or delaying doses can impact the effectiveness of the medication in managing chronic gout.
• Precautions: Inform your healthcare provider about any medical conditions you have, including allergies, previous infusion reactions, or heart problems. They can determine if any precautions or modifications to the treatment plan are necessary.
• Medication interactions: Notify your healthcare provider about all medications you are taking, including prescription drugs, over-the-counter medications, and dietary supplements. Some medications may interact with Krystexxa and require adjustment or monitoring.
• Follow-up appointments: Regular follow-up appointments with your healthcare provider are important to assess the response to treatment, monitor for any side effects, and make any necessary changes to your treatment plan.

Remember to consult with your healthcare provider for specific instructions and advice regarding the storage, disposal, emergencies, and any other important information related to your specific situation and treatment with Krystexxa.