Avalglucosidase Alfa Injection

What is this medication?

AVALGLUCOSIDASE ALFA (AY val gloo KOE si dase AL fa) is an enzyme replacement therapy. It treats late-onset Pompe disease. It is not a cure for late-onset Pompe disease.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Nexviazyme

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• heart failure
• lung disease
• an unusual or allergic reaction to avalglucosidase alfa, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is injected into a vein. It is given my a health care provider in a hospital or clinic setting.

Talk to your health care provider about the use of this medicine in children. While it may be given to children as young as 1 year for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep appointments for follow-up doses. It is important not to miss your dose. Call your health care provider if you are unable to keep an appointment.

What may interact with this medication?

Interactions are not expected.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your health care provider for regular checks on your progress. Tell your health care provider if your symptoms do not start to get better or if they get worse.

This medicine can cause serious allergic reactions. To reduce the risk, your health care provider may give you other medicines to take before receiving this one. Be sure to follow the directions from your health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions (skin rash, itching or hives; swelling of the face, lips, or tongue)
• chest pain
• flushing (redness)
• low blood pressure (dizziness; feeling faint or lightheaded, falls; unusually weak or tired)
• trouble breathing

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• headache
• diarrhea
• joint pain
• muscle pain
• nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This medicine is given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.