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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:  03/11/2005
 
Trade Name:  Rapamune
 
Generic Name or Proper Name (*):  sirolimus
 
Indications Studied:  Prophylaxis of organ rejection in patients undergoing renal transplants
 
Label Changes Summary:  * Safety and efficacy established in children 13 years or older judged to be at low to moderate immunologic risk * Safety was assessed in a controlled clinical trial in pediatric (<18 years of age) renal transplant recipients considered high immunologic risk. The use of Rapamune in combination with calcineurin inhibitors and corticosteroids was associated with an increased risk of deterioration of renal function, lipid abnormalities, and urinary tract infections * Safety and efficacy have not been established in pediatric patients less than 13 years old or in pediatric renal transplant recipients considered at high immunologic risk * Information on PK parameters, adverse events and safety
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Wyeth
 
Pediatric Exclusivity Granted Date:  11/17/2004
 
NNPS:  FALSE
 
Therapeutic Category:  Immunosuppressant
 
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