able 3 ). Plasma pharmacokinetic profiles were also characterized in adult patients with Fabry disease given 1 mg/kg Fabrazyme every 14 days for a total of 11 infusions. Refer to Table 3 below for more details.
In 15 pediatric Fabry patients (ranging in age from 8 to 16 years old and weighing between 27.1 to 64.9 kg) who were dosed with 1 mg/kg every 14 days, Fabrazyme pharmacokinetics were not weight-dependent ( Table 3 ). Fabrazyme concentrations were about five times higher after IgG seroconversion, without any detectable impact on GL-3 clearance.
IgG seroconversion in pediatric patients was associated with prolonged half-life and plasma concentrations of Fabrazyme, a phenomenon rarely observed in adult patients. A possible cause for this prolongation likely pertains to the ability of antibodies to potentially act as “carriers” for their antigens [see Adverse Reactions (6.2) and Use in Specific Populations (8.4) ].
Table 3 - Fabrazyme® Manufacturer
Genzyme Corporation
Active Ingredients
Source
U.S. National Library of Medicine
DailyMed
Last Updated: 2nd of March 2011
