Pegasys (peginterferon alfa-2a)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
WARNINGS AND PRECAUTIONS
Impact on Growth in Pediatric Patients
combination therapy for up to 48 weeks with PEGASYS plus ribavirin
growth inhibition was observed in pediatric subjects 5 to 17 years of
age. Decreases in weight for age z-score and height for age z-score up
to 48 weeks of therapy compared with baseline were observed. At 2 years
post-treatment, 16% of pediatric subjects were more than 15 percentiles
below their baseline weight curve and 11% were more than 15 percentiles
below their baseline height curve.
- The available longer term
data on subjects who were followed up to 6 years post-treatment is too
limited to determine the risk of reduced adult height in some patients
[see Clinical Trials Experience (6.1)].
Labels: FDA Warning, pediatric use, pegasys