Fabrazyme (agalsidase beta)
What is a Generic Drug?
A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
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Prescription Required
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Product Details
Description
Fabrazyme (agalsidase beta) is administered as an intravenous infusion for the treatment of Fabry disease in adults and pediatric patients who are at least 2 years of age.
Fact Table
Formula
C_2569H_3928N_672O_781S_32 (glycoprotein)
License
US FDA, EMA
Bioavailability
Not orally bioavailable (administered IV)
Legal status
Prescription only (Rx)
Chemical Name
Recombinant human alpha-galactosidase A
Elimination half-life
~45–100 minutes (dose-dependent)
Dosage (Strength)
1 mg/kg body weight every 2 weeks (IV infusion)
Pregnancy
Category C – Use only if clearly needed
Brands
Fabrazyme
Protein binding
Not significantly protein-bound
PubChem CID
16144637
MedlinePlus
a605033
ChEBI
133333
ATC code
A16AB04
DrugBank
DB00085
KEGG
D04175
Routes of administration
Intravenous (IV)
Directions
Fabrazyme should be administered as prescribed by your doctor.
Fabrazyme dosing: Your doctor will tell you how much Fabrazyme you will receive and how often.
Fabrazyme should be administered only under direct medical supervision with appropriate medical support measures readily available.
Ingredients
Fabrazyme contains agalsidase beta.
Contraindications
There are no contraindications, or reasons why a person cannot receive Fabrazyme, per the most recent Prescribing Information.
Cautions
- Before you begin treatment with Fabrazyme, tell your doctor about:
- All the prescription and nonprescription medications you take
- Your allergies
- Your current health conditions and past medical history
- Your pregnancy or breastfeeding status
- Severe allergic reactions, including anaphylaxis, can occur during Fabrazyme infusions.
- Infusion-associated reactions can occur. Patients may be pretreated with a fever reducer and antihistamine before receiving Fabrazyme infusions.
Side Effects
The most common side effects associated with Fabrazyme include upper respiratory tract infection, chills, fever, headache, cough, burning or prickling sensation, swelling, dizziness, and rash. However, other side effects may also occur. Contact your doctor right away if you have side effects that bother you or won’t go away.
Reference
Fabrazyme. Cambridge, MA: Genzyme Corporation; 2023.
IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.Product Code : 13934
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