Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
  • Print
  • Share
  • E-mail
-
 
Pediatric Labeling Date:  12/10/2013
 
Trade Name:  Xeloda
 
Generic Name or Proper Name (*):  capecitabine
 
Indications Studied:  Newly diagnosed brainstem gliomas and high grade gliomas
 
Label Changes Summary:  The safety and effectiveness in pediatric patients have not been established No clinical benefit was demonstrated in 2 single arm trials in pediatric patientsThe adverse reaction (AR) profile was consistent with the known AR profile in adults, with the exception of laboratory abnormalities which occurred more commonly in pediatric patientsInformation on dosing, adverse reactions, and clinical trials
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Hoffman- LaRoche
 
NNPS:  FALSE'
 
Therapeutic Category:  Antineoplastic
 
-
-