Abstract
n = 15) at week 38. PK parameters were determined using a noncompartmental analysis method. Mean maximum plasma concentration (Cmax), area under the plasma concentration curve (AUC)0-t, and AUC0-∞ values were higher after the 60U/kg dose than the 30U/kg dose on day 1 and at week 38. The mean time to Cmax (Tmax) ranged from 83-95 min, mean elimination half-life (t1/2) ranged from 25.034.8 min, mean clearance rates (CL) ranged from 19.9-30.7 L/h, and mean volume of distribution (Vss) ranged from 11.7-17.5 L on day 1 and week 38, indicating no dependence on dose or sampling day. Pediatric PK were assessed in a multicenter trial of taliglucerase alfa safety and efficacy in pediatric patients (2-b18 years of age) with GD. Serial blood samples for PK analysis in plasma were obtained from 10 pediatric patientswho received taliglucerase alfa infusions of 30 and 60U/kg every 2 weeks for 10-27 mo. PK parameters were determined using a noncompartmental analysis method. Mean Cmax, AUC0-t, and AUC0-∞ values were higher at the 60U/kg (n= 4) than 30U/kg (n= 6) dose. After dose normalization, these values were similar. Mean values for Tmax and t1/2 were similar for the taliglucerase alfa at 30 and 60U/kg doses. Mean CL was 33% lower (17.0 vs 25.5 L/h, respectively) and Vss was 35% lower (10.7 vs 16.4 L, respectively) for the 60 vs 30U/kg dose groups. After normalization by body weight, these differences decreased to 16% and 23%, respectively, indicating linear PK. Following repeated infusions of taliglucerase alfa, observed mean t1/2 and CL values in pediatric patients (31.5-34.8 min and 17-25.5 L/h, respectively) were similar to those observed in adult patients, indicating comparable taliglucerase alfa PK in pediatric and adult patients with GD. These studies were sponsored by Protalix Biotherapeutics. Pediatric study PB06-006 is ongoing. Editorial and medical writing support was provided by Peloton Advantage, LLC, and was funded by Pfizer.
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