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Fabrazyme is the brand name for agalsidase beta IV infusion.

Fabrazyme is available as a 5 mg or 35 mg single-dose vial.

Fabrazyme is an enzyme replacement therapy used to treat Fabry disease in people 2 years of age and older.

Fabrazyme is an enzyme replacement therapy for people with Fabry disease. It replaces the missing alpha-galactosidase A (alpha-Gal A) enzyme in the body. This enzyme helps clear the buildup of fats called globotriaosylceramide (GL-3) that causes damage to the body in Fabry disease.

The dose is based on your body weight. The typical dose is 1 mg/kg of weight every 2 weeks as an infusion into your veins (intravenous or IV infusion).

Fabrazyme is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you.

Common side effects of Fabrazyme:

• Upper respiratory tract infection
• Chills
• Fever
• Headache
• Cough
• Feeling of “pins and needles”
• Low energy
• Swelling in arms, feet, or ankles
• Dizziness
• Rash
• Arm or leg pain
• Muscle pain
• Lower respiratory tract infection
• Back pain
• High blood pressure (14%)
• Itching

Serious side effects are rare with Fabrazyme. Contact your healthcare provider immediately if you experience any of the following.

• Serious allergic reaction (anaphylaxis): trouble breathing, tightness in the throat, hives, itching, fast heartbeat, nausea, stomach pain, dizziness, lightheadedness, swelling in the face or tongue

• There are no major drug interactions listed for Fabrazyme. However, always let your physician and pharmacist know about any other medications or supplements (including prescribed and over-the-counter medications, vitamins, and dietary or herbal supplements) that you are currently taking

sanofi-aventis U.S.

It is not known if Fabrazyme will harm your unborn baby. Tell your healthcare provider if you become pregnant while taking Fabrazyme. Pregnant women and women of reproductive potential should be encouraged to enroll in the Fabry patient registry. The registry will monitor the effect of Fabrazyme on pregnant women and their offspring. For more information, visit www.registrynxt.com or call 1-800-745-4447, extension 15500.

• Agalsidase Beta