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Alan Franciscus

Editor-in-Chief

HCV Advocate


Wednesday, April 15, 2015

Warning: Pegasys plus Ribavirin Pediatric Use

Pegasys (peginterferon alfa-2a)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
March 2015

WARNINGS AND PRECAUTIONS

Impact on Growth in Pediatric Patients
  • During 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)].

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