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Pegunigalsidase alfa may cause very serious (sometimes fatal) allergic reactions that may happen during or after the infusion. A health care professional will monitor you closely during and after your infusion. Get medical help right away if you notice any symptoms of a serious allergic reaction, such as rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, or fast heartbeat. Your doctor may prescribe other medications (such as antihistamines, corticosteroids) to treat these side effects. Your infusion also may be slowed down or stopped depending on your symptoms.

This medication is given by slow injection into a vein as directed by your doctor, usually every 2 weeks. The injection is given by a health care professional. The dosage is based on your medical condition, weight, and response to treatment.

Infusion reactions may happen during the infusion of this drug and for up to 24 hours afterward. Your doctor may prescribe other medications (such as acetaminophen, antihistamine, corticosteroids) before each treatment to help prevent these side effects. Tell your doctor right away if you have any symptoms of infusion reactions such as chills, flushing, shaking, cold symptoms (such as sneezing, runny/stuffy nose), nausea, vomiting, diarrhea, dizziness, numb/tingling skin, shooting/stabbing pain, muscle pain, shortness of breath, slow heartbeat, headache, or chest/abdominal pain. Your doctor may give you other medications to help with these side effects or may slow down or stop your treatment for some time.

If you are using this medication at home, learn all preparation and usage instructions in the product package and from your health care professional. If any of the information is unclear, consult your doctor or pharmacist. Remove this medication from the refrigerator and allow the medication and mixing solution to warm to room temperature before mixing. Do not shake the mixed drug. Doing so can make it work less well.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder.

Tell your doctor if your condition does not get better or if it gets worse.

Before using pegunigalsidase alfa, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: previous enzyme replacement therapy.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as kidney function) may be done while you are using this medication. Keep all medical and lab appointments.

It is important to get each dose of this medication as scheduled. Do not use an extra dose to make up for a missed dose. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Store in the refrigerator. Do not freeze. After removing from the refrigerator, use the mixed drug within 8 hours. Discard any unused portion. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.