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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:  10/29/2010
 
Trade Name:  Afinitor
 
Generic Name or Proper Name (*):  everolimus
 
Indications Studied:  Treatment of patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis
 
Label Changes Summary:  * Approved for treatment of patients with SEGA associated with TS * An open-label, single-arm safety and efficacy trial was conducted in 28 patients 3-34 years with SEGA associated with TS * Afinitor has not been studied in patients with SEGA < 3 years of age* Most common adverse reactions (incidence e30%) were stomatitis, upper respiratory tract infection, sinusitis, otitis media, and pyrexia* Dose reduction and/or treatment interruption may be needed to manage adverse drug reactions * Information on starting dose, therapeutic drug monitoring, clinical trial, and adverse reactions * New indication
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Novartis
 
NNPS:  FALSE
 
Therapeutic Category:  Antineoplastic
 
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