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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:  06/07/2018
 
Trade Name:  Mircera
 
Generic Name or Proper Name (*):  Methoxy Polyethylene Glycol-Epoetin Beta
 
Indications Studied:  Anemia associated with chronic kidney disease (CKD) in pediatric patients 5 to 17 years of age on hemodialysis who are converting from another erythropoiesis-stimulating agent (ESA) after their hemoglobin level was stabilized with an ESA
 
Label Changes Summary:  *Safety and effectiveness of Mircera for the treatment of anemia due to CKD have been established in pediatric patients 5 to 17 years on hemodialysis who are converting from another ESA after their hemoglobin level was stabilized with an ESA. *The use of Mircera in this pediatric age group is supported by evidence from adequate and well-controlled studies of Mircera in adults and a dose-finding study in 64 pediatric patients 5 to 17 years. *Safety and effectiveness of Mircera have not been established in patients less than 5 years of age. *The safety and effectiveness of Mircera have not been established in pediatric patients of any age for subcutaneous administration; for treatment of anemia in patients with CKD on peritoneal dialysis; for treatment of anemia in patients with CKD who are not yet on dialysis; and for patients whose hemoglobin level has not been previously stabilized by treatment with an ESA. *Administer Mircera only intravenously in pediatric patients. *The adverse reaction profile was similar to those observed in adults. *Information on dosing, adverse reactions, PK parameters and clinical trial. *New indication.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Vifor International AG
 
NNPS:  FALSE
 
Therapeutic Category:  Hematopoietic
 
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