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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:  09/21/2012
 
Trade Name:  Venofer
 
Generic Name or Proper Name (*):  iron sucrose
 
Indications Studied:  Treatment of iron deficiency anemia in patients with chronic kidney disease (CKD)
 
Label Changes Summary:  *Expanded the indication from adults to pediatric patients 2 years and older* Safety and effectiveness for iron maintenance treatment in pediatric patients 2 years of age and older with dialysis-dependent or non-dialysis-dependent CKD receiving erythropoietin therapy were studied *Safety and effectiveness for iron replacement treatment in pediatric patients with dialysis-dependent or non-dialysis-dependent CKD have not been established *Venofer has not been studied in patients < 2 years *The mean Cmax and AUC values were 1.42- and 1.67-fold higher than dose adjusted adult Cmax and AUC values *The most common treatment-emergent adverse reactions were headache (6%), respiratory tract viral infection (4%), peritonitis (4%), vomiting (4%), pyrexia (4%), dizziness (4%), cough (4%), renal transplant (4%), nausea (3%), arteriovenous fistula thrombosis (2%), hypotension (2%), and hypertension (2.1%) *Information on dosing, adverse reactions, pharmacokinetics, and clinical trial * Postmarketing study
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Luitpold Pharmaceuticals
 
NNPS:  FALSE
 
Therapeutic Category:  Iron Replacement
 
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