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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
Therapeutic Category:  Antifungal