Introduction

Agalsidase Beta (aye-GAL-si-days BAY-ta)

Treats Fabry disease (a lack of an enzyme that helps your body break down and use certain kinds of fat).

Brand Name(s)

There may be other brand names for this medicine.

Fabrazyme

When This Medicine Should Not Be Used

You should not use this medicine if you have ever had an allergic reaction to agalsidase.

How to Use This Medicine

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given through a needle placed in one of your veins.
• A nurse or other trained health professional will give you this medicine.

If a dose is missed:

• This medicine needs to be given every two weeks. If you miss an appointment, call your doctor or treatment clinic for instructions.

How to Store and Dispose of This Medicine

• If you receive your treatments at a clinic, your medicine will be kept there.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breast feeding, or if you have a history of heart problems.
• This medicine causes a fever in most patients. Your doctor might give you a medicine (such as Tylenol®) to prevent fever before you receive your treatment.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing.
• Chest pain.
• Fast, or uneven heartbeat.
• Fever, or chills.
• Rash.
• Redness, pain, or swelling where the IV is given.
• Swelling of your lips or ears.

If you notice these less serious side effects, talk with your doctor:

• Headache, or dizziness.
• Loss of color in your skin.
• Mild nausea or vomiting.
• Muscle, bone, or joint pain.
• Stomach pain.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088