Pegunigalsidase Alfa Injection

What is this medication?

PEGUNIGALSIDASE ALFA (peg OOH nee GAL si dase al fa) treats Fabry disease. It works by replacing an enzyme normally made by the body, which reduces the buildup fatty substances (lipids) in the eyes, kidneys, heart, and other tissues. This decreases symptoms and the risk of serious health problems.

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

COMMON BRAND NAME(S): ELFABRIO

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
• Kidney disease
• An unusual or allergic reaction to pegunigalsidase alfa, agalsidase beta, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

This medication is infused 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 have not been studied.

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 infusion 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.

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
• Kidney injury (glomerulonephritis)—decrease in the amount of urine, red or dark brown urine, foamy or bubbly urine, swelling of the ankles, hands, or feet

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

• Diarrhea
• Fatigue
• Headache
• Nausea
• Runny or stuffy nose
• Sore throat

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.