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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:  08/22/2011
 
Trade Name:  Copegus and PEGASYS
 
Generic Name or Proper Name (*):  ribavirin and peginterferon alfa-2a
 
Indications Studied:  Treatment of chronic hepatitis C in patients 5 to 17 years of age
 
Label Changes Summary:  Extended indication from adults to pediatric patients 5-17 yearsSafety and effectiveness of PEGASYS, alone or in combination with COPEGUS in patients < of 5 years have not been establishedPediatric patients treated with PEGASYS plus COPEGUS combination therapy showed a delay in weight and height increases after 48 weeks of therapy compared with baseline. At the end of 2 years follow-up after treatment, most patients returned to baseline normative growth curve percentiles for weight and heightDecreases in hemoglobin, neutrophils and platelets may require dose reduction or permanent discontinuation from treatment If toxicities occur which may be related to PEGASYS or COPEGUS administration, the dose of one or both can be modifiedAdverse reactions were similar to adultsInformation on dosing, clinical trial, and adverse reactions
 
Product Labeling:  Labeling;href='http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103964s5213lbl.pdf'>Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Hoffman- LaRoche
 
NNPS:  FALSE'
 
Therapeutic Category:  Antiviral
 
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