*Not an actual patient.
*Not an actual patient.
In a subset of 24 pediatric patients from Study 044, safety results were consistent with those of the overall population (N=95):3
No new safety concerns were identified.3
No serious adverse events were related to treatment with VPRIV.3
No serious infusion-related adverse events occurred.3
No patient discontinued the study due to an adverse event.3
One pediatric patient tested positive for IgG anti-velaglucerase antibodies in Study 044.3
– No apparent impact was noted on the efficacy of VPRIV as assessed by changes in hemoglobin concentration and platelet count.3
Adverse reactions more commonly seen in pediatric patients compared with adult patients include (>10% difference): rash, prolonged aPTT, and pyrexia.1
Efficacy and safety have not been established in children younger than 4 years.1
HEMOGLOBIN CONCENTRATION
Median hemoglobin concentration at baseline:* 10.75 g/dL3
Mean change at 24 months: 2.65 g/dL3
PLATELET COUNT
Median platelet count at baseline:* 116 × 109/L3
Mean change at 24 months: 79.13 × 109/L3
SPLEEN VOLUME
Median spleen volume at baseline:* 14.3 MN3
Mean change at 24 months: −2.55% of body weight3
LIVER VOLUME
Median liver volume at baseline:* 1.6 MN3
Mean change at 24 months: −1.14% of body weight3
*Baseline is defined as before the first dose of VPRIV in Studies 032 and 039
MN, multiples of normal.