Active Ingredient: Agalsidase beta
Agalsidase beta is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (α-galactosidase A deficiency).
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
1 mg per kg of body weight
1 mg per kg of body weight once every 14 day(s)
The recommended dose of agalsidase beta is 1 mg/kg body weight administered once every 2 weeks as an intravenous infusion.
The safety and efficacy of Fabrazyme in children aged 0 to7 years have not yet been established. Currently available data are described in sections 5.1 and 5.2 but no recommendation on posology canbe made in children aged 5 to 7 years. No data are available in children 0 to 4 yearsNo dose adjustment is necessary for children 8-16 years
The initial infusion rate should be no more than 0.25 mg/min (15 mg/hour) to minimise the potential occurrence of infusion-associated reactions. After patient tolerance is established, the infusion rate may be increased gradually with subsequent infusions.
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