Agalsidase Beta injection

What is this medication?

AGALSIDASE BETA is used to replace an enzyme that is missing in patients with Fabry disease. It is not a cure.

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

COMMON BRAND NAME(S): Fabrazyme

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
• an unusual or allergic reaction to agalsidase beta, mannitol, 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 by 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 prescribed for children as young as 2 years 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?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medication?

• amiodarone
• chloroquine
• gentamicin
• hydroxychloroquine
• monobenzone

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

There is a registry for patients with Fabry disease. The registry is used to gather information about the disease and its effects. Talk to your health care provider if you would like to join the registry.

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 like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• chest pain, tightness
• depression
• dizziness
• fast, irregular heart beat
• swelling of the arms or legs

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

• aches or pains
• anxiety
• fever or chills at the time of injection
• headache
• nausea, vomiting
• stomach pain, upset

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 drug is given in a hospital or clinic and 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.