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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:  07/29/2008
 
Trade Name:  Cancidas
 
Generic Name or Proper Name (*):  caspofungin
 
Indications Studied:  Empirical therapy for presumed fungal infections in febrile, neutropenic patients; Candidemia and certain Candida infections; Esophageal Candidiasis; Invasive Aspergillosis in patients who are refractory to or intolerant of other therapies
 
Label Changes Summary:  Extended indication from adults to children 3 months and older based upon evidence from adequate and well-controlled studies in adults and PK data in pediatric patients and additional data from pediatric studies The efficacy and safety have not been adequately studied in infants < 3 months The ability of caspofungin to penetrate the blood-brain barrier and to treat patients with meningitis and endocarditis is unknown Dosing should be based on the patients body surface area. Maximum loading dose and daily maintenance dose should not exceed 70 mg The safety profile in pediatrics is comparably to adults Information on dose, Aes, PK parameters, clinical studies and infusion preparation instructions
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  Merck
 
Pediatric Exclusivity Granted Date:  04/15/2008
 
NNPS:  FALSE'
 
Therapeutic Category:  Antifungal
 
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