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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:  01/29/2019
 
Trade Name:  Vfend
 
Generic Name or Proper Name (*):  voriconazole
 
Indications Studied:  (1) Invasive aspergillosis (2) Candidemia and disseminated candidiasis in skin, abdomen, kidney, bladder wall, and wounds (3) Esophageal candidiasis (4) Serious infections caused by Scedosporium apiospermum and Fusarium species in patients intolerant of, or refractory to, other therapy.
 
Label Changes Summary:  • Expanded indications down to 2 years; previously approved in 12 years and older. • Safety and effectiveness have been established in pediatric patients 2 years of age and older based on evidence from adequate and well-controlled studies in adult and pediatric patients and additional pediatric pharmacokinetic and safety data. A total of 105 pediatric patients aged 2 to less than 12 [N=26] and aged 12 to less than 18 [N=79] from two, non-comparative Phase 3 pediatric studies and eight adult therapeutic trials provided safety information for Vfend use in the pediatric population. • Safety and effectiveness in pediatric patients below the age of 2 years has not been established. Therefore, Vfend is not recommended for pediatric patients less than 2 years of age. • The frequency of phototoxicity reactions is higher in the pediatric population. Squamous cell carcinoma has been reported in patients who experience photosensitivity reactions. [INVALID]nt measures for photoprotection are warranted. Sun avoidance and dermatologic follow-up are recommended in pediatric patients experiencing photoaging injuries, such as lentigines or ephelides, even after treatment discontinuation. • A higher frequency of liver enzyme elevations was observed in the pediatric patients. Hepatic function and serum creatinine levels should be closely monitored in pediatric patients. • There have been postmarketing reports of pancreatitis in pediatric patients. • Information on dosing, adverse reactions, PK parameters, and clinical studies. • Postmarketing study
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B,P
 
Sponsor:  C.V. PF PRISM
 
NNPS:  FALSE
 
Therapeutic Category:  Antifungal
 
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