Brand Name(s): Fabrazyme

Generic Name Agalsidase Beta

What is agalsidase beta injection?

AGALSIDASE BETA (Fabrazyme®) is a drug that is used to replace an enzyme that is missing in patients with Fabry disease. Because of a lack of this enzyme, a fat substance is not removed from the cells of the body, which can lead to kidney problems and other health issues. This drug may help relieve some symptoms of Fabry disease; it is not a cure. Information and support for patients with Fabry disease is available from the manufacturer by calling (600)—463—1355. A generic agalsidase beta injection is not yet available.

What should my health care professional know before I receive agalsidase beta?

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

• heart disease
• an unusual reaction to agalsidase beta, agalsidase alfa, mannitol, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should this medicine be used?

Agalsidase beta is for injection into a vein. It is given as an infusion by a health care professional in a hospital or clinic setting.

What if I miss a dose?

It is important to receive agalsidase beta on the schedule developed by your health care provider. If you cannot make an appointment to receive your infusion, contact your provider to reschedule as soon as possible.

What drug(s) may interact with agalsidase beta?

• amiodarone
• chloroquine
• gentamicin
• hydroxychloroquine

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What side effects may I notice from receiving agalsidase beta?

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

• chest pain or chest tightness
• depression
• dizziness
• rapid heart beat or racing heart
• shortness of breath or difficulty breathing
• skin rash, hives or itching
• swelling of the face, lips, neck, ears, arms or legs
• throat tightness

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

• abdominal pain
• anxiety
• fever or chills
• headache
• heartburn or upset stomach
• muscle or joint pain
• nausea/vomiting
• pain in the hands, feet, arms, legs, or genital area

What should I watch for while taking agalsidase beta?

Visit your prescriber or health care professional for regular checks on your progress.

Agalsidase beta may cause more severe symptoms in patients with heart disease. If you notice symptoms such as increased shortness of breath, swelling of any body part, chest pain or tightness, or a rapid heart beat, contact your health care provider immediately.

Where can I keep my medicine?

You will receive agalsidase beta in a clinic setting. You will not take this medication at home.