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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
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Pediatric Labeling Date:  12/11/2008
 
Trade Name:  PegIntron
 
Generic Name or Proper Name (*):  Peginterferon alfa-2b
 
Indications Studied:  Co-administered with ritonavir to treat chronic hepatitis C in patients 3 years of age and older with compensated liver disease previously untreated with interferon alpha
 
Label Changes Summary:  Safety and efficacy established in pediatric patients 317 years of age Safety and effectiveness in patients < 3 years have not been established. Dosing for pediatric patients is determined by body surface area for peginterferon alfa-2b and by body weight for ritonavir An open-label study in patients 3 - 17 years showed weight and height gain of pediatric patients treated with combination therapy lags behind that predicted by population data while on treatment. Adverse events similar to those observed in adults. Most common pediatric adverse events were pyrexia, headache, neutropenia, fatigue, anorexia, injection site erythema, vomiting Information on PK parameters, and clinical study New indication
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Schering
 
NNPS:  FALSE'
 
Therapeutic Category:  Antiviral
 
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