WARNING

Pegunigalsidase alfa-iwxj is a medication used to treat Fabry disease, a rare genetic disorder. Like any medication, it carries certain risks, including:

• Allergic reactions: Some individuals may experience allergic reactions to Pegunigalsidase alfa-iwxj, which can range from mild to severe. Symptoms may include rash, itching, swelling, dizziness, difficulty breathing, and low blood pressure.
• Infusion reactions: During or after the infusion of Pegunigalsidase alfa-iwxj, patients may experience infusion-related reactions such as fever, chills, headache, nausea, vomiting, fatigue, and muscle or joint pain.
• Hypersensitivity: Patients may develop hypersensitivity reactions to Pegunigalsidase alfa-iwxj, which could manifest as skin reactions, respiratory symptoms, gastrointestinal issues, or other systemic symptoms.
• Antibody development: Some individuals may develop antibodies against Pegunigalsidase alfa-iwxj, which could potentially reduce its effectiveness or cause adverse reactions.
• Acute kidney injury: In rare cases, Pegunigalsidase alfa-iwxj may lead to acute kidney injury, particularly in patients with pre-existing kidney problems.
• Infusion site reactions: Patients may experience local reactions at the infusion site, such as pain, swelling, redness, or irritation.
• Elevated antibody levels: Long-term use of Pegunigalsidase alfa-iwxj may lead to elevated levels of antibodies, which could impact its efficacy over time.

It’s essential for patients to discuss any concerns or potential risks with their healthcare provider before starting Pegunigalsidase alfa-iwxj treatment. Healthcare professionals can help patients understand the benefits and risks associated with this medication and monitor them closely for any adverse reactions during treatment.

Why is this medication prescribed?

Pegunigalsidase alfa-iwxj is prescribed for the treatment of Fabry disease, a rare genetic disorder characterized by the buildup of a specific type of fat in the body’s cells. This buildup can lead to various symptoms, including pain, kidney dysfunction, heart problems, and neurological issues.

Pegunigalsidase alfa-iwxj is a type of enzyme replacement therapy that works by replacing the deficient or malfunctioning enzyme responsible for breaking down the accumulated fat in individuals with Fabry disease. By providing the missing enzyme, Pegunigalsidase alfa-iwxj helps to reduce the buildup of fat in the body’s cells and alleviate symptoms associated with Fabry disease.

How should this medicine be used?

As for its usage:

• Administration: Pegunigalsidase alfa-iwxj is typically administered via intravenous infusion, meaning it is injected directly into a vein.
• Dosage: The dosage and frequency of administration of Pegunigalsidase alfa-iwxj will vary depending on factors such as the patient’s weight, severity of Fabry disease, and individual response to treatment. Your healthcare provider will determine the appropriate dosage regimen for you.
• Infusion process: The infusion of Pegunigalsidase alfa-iwxj is usually performed in a clinical setting by trained healthcare professionals. The medication is diluted and administered slowly over a specified period, typically ranging from 1 to 2 hours, to minimize the risk of infusion-related reactions.
• Monitoring: Patients receiving Pegunigalsidase alfa-iwxj will be closely monitored during and after infusion for any adverse reactions or side effects. This monitoring may include vital signs assessment, laboratory tests, and evaluation of infusion site reactions.
• Follow-up appointments: Patients may require regular follow-up appointments with their healthcare provider to assess the effectiveness of treatment, monitor for any changes in symptoms or side effects, and adjust the treatment regimen as needed.

It’s crucial for patients to strictly adhere to their healthcare provider’s instructions regarding the administration of Pegunigalsidase alfa-iwxj and to report any concerns or adverse reactions promptly. Additionally, patients should discuss any other medications or supplements they are taking with their healthcare provider, as they may interact with Pegunigalsidase alfa-iwxj.

Other uses for this medicine

Pegunigalsidase alfa-iwxj is primarily used for the treatment of Fabry disease, and its use for other conditions has not been established. It is an enzyme replacement therapy specifically designed to address the enzyme deficiency in Fabry disease by replacing the missing or deficient enzyme, alpha-galactosidase A.

What special precautions should I follow?

As for special precautions to follow when using Pegunigalsidase alfa-iwxj:

• Allergic reactions: Patients should be monitored for signs of allergic reactions during and after the infusion of Pegunigalsidase alfa-iwxj. Symptoms may include rash, itching, swelling, difficulty breathing, and low blood pressure. If any allergic reactions occur, immediate medical attention should be sought.
• Infusion-related reactions: Patients may experience infusion-related reactions, such as fever, chills, headache, nausea, vomiting, fatigue, and muscle or joint pain. These reactions typically occur during or shortly after the infusion and may require adjustments to the infusion rate or other supportive measures.
• Hypersensitivity: Individuals with a history of hypersensitivity reactions to Pegunigalsidase alfa-iwxj or any of its components should use the medication with caution. Close monitoring is necessary, and the infusion may need to be stopped if severe hypersensitivity reactions occur.
• Antibody development: Some patients may develop antibodies against Pegunigalsidase alfa-iwxj over time, which could potentially reduce its effectiveness or lead to adverse reactions. Regular monitoring for antibody development may be necessary in certain cases.
• Kidney function: Pegunigalsidase alfa-iwxj may cause acute kidney injury in rare cases, particularly in patients with pre-existing kidney problems. Therefore, kidney function should be monitored regularly during treatment.
• Pregnancy and breastfeeding: The safety of Pegunigalsidase alfa-iwxj during pregnancy and breastfeeding has not been established. Pregnant or breastfeeding individuals should discuss the potential risks and benefits of treatment with their healthcare provider before using Pegunigalsidase alfa-iwxj.
• Other medications: Patients should inform their healthcare provider about all medications, supplements, and herbal products they are taking, as certain medications may interact with Pegunigalsidase alfa-iwxj.

It’s essential for patients to follow their healthcare provider’s instructions carefully and to report any side effects or concerns promptly. Close monitoring and regular follow-up appointments are typically recommended to ensure the safe and effective use of Pegunigalsidase alfa-iwxj.

What special dietary instructions should I follow?

There are no specific dietary instructions associated with Pegunigalsidase alfa-iwxj Injection. However, patients should follow a balanced and healthy diet as recommended by their healthcare provider, especially if they have underlying health conditions such as Fabry disease. It’s important to maintain a diet that supports overall health and well-being.

What should I do if I forget a dose?

If you miss a dose of Pegunigalsidase alfa-iwxj, it’s important to contact your healthcare provider as soon as possible for guidance. Depending on the specific circumstances, your healthcare provider may recommend rescheduling the missed dose or adjusting your treatment plan accordingly. It’s crucial not to double the dose to make up for a missed one unless advised by your healthcare provider.

What side effects can this medication cause?

Pegunigalsidase alfa-iwxj Injection, like any medication, can cause side effects. Not everyone will experience these side effects, and their severity can vary. Common side effects of Pegunigalsidase alfa-iwxj Injection may include:

• Infusion-related reactions: These can include fever, chills, headache, nausea, vomiting, fatigue, muscle or joint pain, and flushing.
• Allergic reactions: Some individuals may experience allergic reactions to Pegunigalsidase alfa-iwxj Injection, which can range from mild to severe. Symptoms may include rash, itching, swelling, difficulty breathing, and low blood pressure.
• Hypersensitivity reactions: Patients may develop hypersensitivity reactions to Pegunigalsidase alfa-iwxj Injection, which could manifest as skin reactions, respiratory symptoms, gastrointestinal issues, or other systemic symptoms.
• Antibody development: Some patients may develop antibodies against Pegunigalsidase alfa-iwxj Injection over time, potentially leading to reduced effectiveness or adverse reactions.
• Infusion site reactions: Patients may experience local reactions at the infusion site, such as pain, swelling, redness, or irritation.
• Acute kidney injury: In rare cases, Pegunigalsidase alfa-iwxj Injection may lead to acute kidney injury, particularly in patients with pre-existing kidney problems.

It’s important for patients to report any side effects or adverse reactions to their healthcare provider promptly. Your healthcare provider can provide guidance on managing side effects and may adjust your treatment plan if necessary. Additionally, patients should be monitored closely during and after infusion for any signs of side effects or allergic reactions.

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

Storage and disposal of Pegunigalsidase alfa-iwxj Injection:

• Storage: Pegunigalsidase alfa-iwxj Injection should be stored in the refrigerator at a temperature between 2°C to 8°C (36°F to 46°F). Do not freeze the medication. Keep Pegunigalsidase alfa-iwxj Injection in its original packaging until ready for use to protect it from light.
• Handling: Pegunigalsidase alfa-iwxj Injection should be inspected visually for particulate matter and discoloration before administration. Do not use the medication if it appears cloudy, discolored, or contains particles.
• Disposal: Unused Pegunigalsidase alfa-iwxj Injection and any materials used during administration, such as needles and syringes, should be disposed of properly according to local regulations. Consult with your healthcare provider or pharmacist for guidance on safe disposal methods.

In case of emergency/overdose

If you suspect an overdose or experience severe adverse reactions after receiving Pegunigalsidase alfa-iwxj Injection, seek immediate medical attention. Contact your healthcare provider or go to the nearest emergency room for evaluation and treatment. Be sure to bring the medication packaging or any remaining vials with you to the healthcare facility.

What other information should I know?

• Follow-up appointments: Patients receiving Pegunigalsidase alfa-iwxj Injection may require regular follow-up appointments with their healthcare provider to monitor the effectiveness of treatment and assess for any adverse reactions or side effects.
• Compliance: It’s essential to adhere to the prescribed dosage regimen and administration schedule for Pegunigalsidase alfa-iwxj Injection as instructed by your healthcare provider.
• Interactions: Inform your healthcare provider about all medications, supplements, and herbal products you are taking, as they may interact with Pegunigalsidase alfa-iwxj Injection.
• Travel: If you need to travel with Pegunigalsidase alfa-iwxj Injection, take necessary precautions to ensure proper storage and transportation according to manufacturer recommendations.
• Support: Patients with Fabry disease receiving Pegunigalsidase alfa-iwxj Injection may benefit from support groups or resources available for individuals living with rare diseases. Your healthcare provider or patient advocacy organizations can provide information and assistance.