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Fabrazyme
Agalsidase Beta
$5390.00
35mg · 35 vial
BrandBranded medicine· By Sanofi
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FDA boxed warningHypersensitivity reactions including anaphylaxis
Patients treated with enzyme replacement therapies have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. Initiate FABRAZYME in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue FABRAZYME and immediately initiate appropriate medical treatment, including use of epinephrine. Inform patients of the symptoms of life-threatening hypersensitivity reactions, including anaphylaxis and to seek immediate medical care should symptoms occur..
About Fabrazyme
Overview
Fabrazyme (agalsidase beta) is an enzyme treatment given by intravenous infusion. It is used to treat adults and children aged 2 years and older with confirmed Fabry disease. It supplies the enzyme alpha-galactosidase A, which works inside cells to break down and reduce a buildup of a substance called GL-3.
What it treats
Treatment of confirmed Fabry disease in adults and children aged 2 years and older.
Safety information
Side effects
Common side effects include upper respiratory tract infections, chills, fever, headache, cough, tingling or prickling sensations, tiredness, swelling in the arms or legs, dizziness and rash. Serious reactions include allergic reactions, including anaphylaxis, and reactions associated with the infusion. Seek immediate medical attention for a serious allergic or infusion-related reaction. If a severe infusion-related reaction occurs, Fabrazyme must be stopped immediately and appropriate medical treatment started.
FDA boxed warning
Hypersensitivity reactions including anaphylaxis
Patients treated with enzyme replacement therapies have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. Initiate FABRAZYME in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue FABRAZYME and immediately initiate appropriate medical treatment, including use of epinephrine. Inform patients of the symptoms of life-threatening hypersensitivity reactions, including anaphylaxis and to seek immediate medical care should symptoms occur..
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
The label lists no contraindications. A severe infusion-associated reaction requires Fabrazyme to be stopped immediately and appropriate medical treatment to be started.
Using Fabrazyme
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store in the original carton below 25°C, protected from light, unless the pack states refrigeration. Do not freeze. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label FABRAZYME (AGALSIDASE BETA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION] (DailyMed, retrieved 19 September 2026).
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