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:  11/25/2016
 
Trade Name:  Renvela
 
Generic Name or Proper Name (*):  sevelamer carbonate
 
Indications Studied:  Control of serum phosphorus in children 6 years of age and older with chronic kidney disease on dialysis
 
Label Changes Summary:  *Expanded the indication from adults to pediatric patients ages 6 years and older. *Renvela has not been studied in pediatric patients below 6 years of age. *Most adverse events that were reported as related, or possibly related, to sevelamer carbonate were gastrointestinal in nature. *Information on starting dose and titration, adverse reactions and clinical trial. *Postmarketing study
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Genzyme
 
NNPS:  FALSE
 
Therapeutic Category:  Phosphate binder
 
-
-