WARNING

Pegunigalsidase alfa-iwxj may result in infusion-related events during and within 24 hours following infusions. It has been linked to hypersensitivity (severe allergic) reactions, including anaphylaxis. Throughout your infusion, a nurse or doctor will keep a close eye on you. Inform your doctor right once if you encounter any of the following symptoms, or seek emergency medical attention: headache, nausea, vomiting, diarrhea, stomach pain, hives, rash, itching, fever, chills, disorientation, weakness, trouble breathing, fast or irregular heartbeat, or chest pain. You may also experience swelling of your lips, tongue, or neck. In order to lower the likelihood of these occurrences, your doctor could prescribe medication to you before each infusion.

Why is this medication prescribed?

The injection of pegunigalsidase alfa-iwxj is used to treat Fabry disease, a genetic ailment where the body accumulates a particular type of fatty material that damages nerves and organs. The injectable pegunigalsidase alfa-iwxj belongs to a class of drugs known as enzymes. The way it functions is by taking the place of an enzyme that the body typically produces to assist stop the accumulation of fat in

How should this medicine be used?

Pegunigalsidase alfa-iwxj injection is administered intravenously (into a vein) by a medical professional as a solution (liquid). Usually administered intravenously once every two weeks, pegunigalsidase alfa-iwxj injection is infused (given slowly) over a duration of 90 minutes to 6 hours.

You will first receive injections of pegunigalsidase alfa-iwxj in a medical facility for a minimum of four to six infusions. Your doctor may opt to allow you to take this drug at home with the guidance of a healthcare provider if the prior infusions were well tolerated.

Serious side effects may occur with pegunigalsidase alfa-iwxj injection during or after infusion. Throughout the infusion of medication, a medical professional or nurse will closely monitor you for these side effects. If you have these side effects, your doctor might need to reduce the pace of your infusion or discontinue it altogether.

Other uses for this medicine

Ask your doctor or pharmacist for more information if you think this medicine could be recommended for something else.

What special precautions should I follow?

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

• If you have an allergy to pegunigalsidase alfa-iwxj, any other drug, or any of the ingredients in pegunigalsidase alfa-iwxj injection, let your doctor and pharmacist know. Get an ingredient list from your pharmacist.
• Inform your physician and pharmacist about all of the vitamins, nutritional supplements, herbal items, prescription and over-the-counter drugs, and vitamins you now take or intend to take.
• Inform your physician if you now have or have ever had renal or cardiac issues.
• Inform your physician if you are nursing a baby, intend to get pregnant, or are already pregnant. Contact your physician if you become pregnant after taking an injection of pegunigalsidase alfa-iwxj.

Patients should always follow their healthcare provider’s instructions regarding the use of pegunigalsidase alfa-iwxj injection, 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?

• Your healthcare provider will provide specific guidance on dietary instructions if they are relevant to your treatment with Pegunigalsidase alfa-iwxj.
• In some cases, dietary restrictions or recommendations may be part of the overall management plan for a particular condition.

What should I do if I forget a dose?

• If you forget a dose, contact your healthcare provider or follow the instructions provided in the medication guide.
• Do not double the dose to make up for a missed one unless instructed to do so by your healthcare provider.

What side effects can this medication cause?

Pegunigalsidase alfa-iwxj 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 Pegunigalsidase alfa-iwxj:

• Nasal congestion or runny nose
• Sore throat
• Arm, leg, or back pain
• Fatigue
• Numbness or tingling in the your hands, feet, arms, or legs
• Redness or swelling at the injection site

There may be dangerous negative effects. Contact your physician right away if you encounter any of the following symptoms, as well as those mentioned in the  WARNING section, or seek emergency medical attention:

• Decreased urination; foamy, pink, or brown colored urine; swelling in hands, face, feet or stomach

Additional adverse effects are possible with pegunigalsidase alfa-iwxj. If you have any odd side effects while taking this medicine, contact your doctor.

It’s crucial to report any side effects or concerns to your healthcare provider promptly. The decision to use this medication 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 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:
  • Store the medication as directed on the packaging.
  • Keep it in a cool, dry place, away from direct sunlight and heat.
  • Check if the medication requires refrigeration, and if so, follow those specific guidelines.
• Disposal:
  • Follow any specific disposal instructions provided by your healthcare provider or on the medication packaging.
  • Do not flush medications down the toilet unless specifically instructed to do so.
  • Many communities have drug take-back programs or pharmacies that can assist with proper disposal.

In case of emergency/overdose

• In case of an emergency or suspected overdose, contact your local emergency services immediately.
• If possible, have the medication packaging or information available for healthcare professionals.

What other information should I know?

• Inform your healthcare provider of all the medications you are taking, including prescription and over-the-counter drugs, as well as any supplements.
• Report any side effects or concerns to your healthcare provider promptly.
• Attend scheduled follow-up appointments to monitor your response to the medication.

Remember, the information provided here is general. Always consult with your healthcare provider or pharmacist for specific and personalized guidance regarding the storage, disposal, and other important considerations related to Pegunigalsidase alfa-iwxj injection.