Cipaglucosidase Alfa Injection

What is this medication?

CIPAGLUCOSIDASE ALFA (sip a gloo koe si dase al fa) treats Pompe disease. It works by replacing an enzyme normally made by the body, which reduces the buildup of sugar (glycogen) in your muscles. This decreases symptoms.

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

COMMON BRAND NAME(S): POMBILITI

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

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

• Heart disease
• Lung disease
• An unusual or allergic reaction to cipaglucosidase alfa, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

This medication is injected into a vein. It is given by your care team in a hospital or clinic setting.

Talk to your care team about the use of this medication in children. Special care may be needed.

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

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

Talk to your care team if you may be pregnant. Serious birth defects can occur if you take this medication during pregnancy. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for 60 days after the last dose. Your care team can help you find the option that works for you.

Do not breastfeed while taking this medication.

This medication may cause infertility. Talk to your care team if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Infusion reactions—chest pain, shortness of breath or trouble breathing, feeling faint or lightheaded

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

• Diarrhea
• Fatigue
• Fever
• Headache
• Nausea
• Stomach pain

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 medication 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.