This notice was prepared by Rebecca Waxbom, Pharm.D., BCNSP and Dale Whitby, PharmD (PPAG Members)
On April 23, 2015, the FDA expanded approval of valganciclovir for the prevention of CMV infection in pediatric heart transplant patients as young as 1 month of age. The drug was previously approved for use in pediatric patients 4 months and older, and the approval for kidney transplant patients remains at patients 4 months and older. The duration of therapy for pediatric kidney transplant patients was also extended from 100 days to 200 days post-transplantation. Additionally, all calculated pediatric doses are now recommended to be rounded to the nearest 10-mg increment compared to the previous recommendation of 25-mg increment. The new product label is also one of the first to follow the FDA’s new format for pregnancy, lactation, and reproductive potential content.
Valganciclovir is currently available as a 50 mg/ml oral solution and 450-mg tablets.
For more information: valcyte.com/patient