Molecule
Agalsidase beta is a hydrolytic lysosomal neutral glycosphingolipid-specific enzyme indicated for the treatment of adult and pediatric patients 2 years of age and older with confirmed Fabry disease. MedsAcross supplies Agalsidase beta for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
FABRAZYME ® is indicated for the treatment of adult and pediatric patients 2 years of age and older with confirmed Fabry disease. FABRAZYME is a hydrolytic lysosomal neutral glycosphingolipid-specific enzyme indicated for the treatment of adult and pediatric patients 2 years of age and older with confirmed Fabry disease.
Source: US FDA prescribing information
FABRAZYME (agalsidase beta) provides an exogenous source of α-galactosidase A in Fabry disease patients. Agalsidase beta is internalized and transported into lysosomes where it exerts enzymatic activity and reduces accumulated GL-3.
Source: US FDA prescribing information
Administration of FABRAZYME should be supervised by a healthcare provider knowledgeable in the management of hypersensitivity reactions including anaphylaxis. The recommended dosage is 1 mg/kg body weight given every two weeks as an intravenous infusion. See the full prescribing information for rechallenge, preparation, storage, and administration instructions.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
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. Infusion-Associated Reactions: If a severe infusion-associated reaction occurs, discontinue FABRAZYME immediately and initiate appropriate medical treatment.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in labeling: Hypersensitivity Reactions Including Anaphylaxis Infusion-Associated Reactions Most common adverse reactions (≥20%) are: upper respiratory tract infection, chills, pyrexia, headache, cough, paresthesia, fatigue, peripheral edema, dizziness, and rash.
Source: US FDA prescribing information
Refrigerate vials of FABRAZYME at 2°C to 8°C (36°F to 46°F). If immediate use is not possible, the reconstituted and diluted solution may be stored for up to 24 hours at 2°C to 8°C (36°F to 46°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Agalsidase beta, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Fabrazyme 5 mg/mL powder for injectionIntravenous Cold chain | Genzyme | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Agalsidase beta in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 1 presentations of Agalsidase beta and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Agalsidase beta, including Fabrazyme.
Yes. The US FDA first approved Agalsidase beta on 24 April 2003, according to Drugs@FDA.
Yes. Agalsidase beta has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Agalsidase beta must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Agalsidase beta is classified under ATC code A16AB04 (Agalsidase alfa).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.