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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 years* Safety and effectiveness of PEGASYS, alone or in combination with COPEGUS in patients < of 5 years have not been established* Pediatric 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 height* Decreases 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 modified* Adverse reactions were similar to adults* Information on dosing, clinical trial, and adverse reactions
 
Product Labeling:  Labeling; Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Hoffman- LaRoche
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
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