Product Information
Registration Status: ActiveFABRAZYME 35MG (AGALSIDASE BETA) is approved to be sold in Singapore with effective from 2009-10-03. It is marketed by SANOFI-AVENTIS SINGAPORE PTE LTD, with the registration number of SIN13609P.
This product contains Agalsidase Beta 37mg/35mg vial in the form of INJECTION, POWDER, FOR SOLUTION. It is approved for INTRAVENOUS use.
This product is manufactured by Genzyme Corporation in UNITED STATES, andHospira Inc in IRELAND.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Description
Recombinant human alpha-galactosidase A. The mature protein is composed of 2 subunits of 398 residues. Protein is glycosylated and produced by CHO cells
Indication
For treatment of Fabry's disease (alpha-galactosidase A deficiency)
Mechanism of Action
Alpha-galactosidase A catalyzes the hydrolysis of globotriaosylceramide (GL-3) and other a-galactyl-terminated neutral glycosphingolipids, such as galabiosylceramide and blood group B substances to ceramide dihexoside and galactose.
Clearance
* 4.1 +/- 1.2 mL/min/kg [adult patients with Fabry disease,0.3 mg/kg, 1 infusion] * 4.6 +/- 2.2 mL/min/kg [adult patients with Fabry disease, 0.3 mg/kg, 5 infusions] * 2.1 +/- 0.7 mL/min/kg [adult patients with Fabry disease, 1 mg/kg, 1 infusion] * 3.2 +/- 2.6 mL/min/kg [adult patients with Fabry disease, 1 mg/kg, 5 infusions] * 0.8 +/- 0.3 mL/min/kg [adult patients with Fabry disease, 3 mg/kg, 1 infusion] * 0.8 +/- 0.4 mL/min/kg [adult patients with Fabry disease, 3 mg/kg, 5 infusions] * 1.8 +/- 0.8 mL/min/kg [Pediatric Patients with Fabry Disease, 1 mg/kg, 1-3 infusions] * 4.9 +/- 5.6 mL/min/kg [Pediatric Patients with Fabry Disease, 1 mg/kg, 7 infusions] * 2.3 +/- 2.2 mL/min/kg [Pediatric Patients with Fabry Disease, 1 mg/kg, 11 infusions]
Active Ingredient/Synonyms
Agalsidase alfa | Alpha-D- galactoside galactohydrolase | Alpha-D-galactosidase A | Alpha-galactosidase A precursor | Melibiase | Agalsidase beta |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.