The Food and Drug Administration (FDA) announced that the product label for Kaletra (lopinavir/ritonavir; AbbVie) has been updated to include drug interaction information and to update the Specific Populations, Pediatric Use subsection.
- The clinical comment for use with etravirine states: Because the reduction in the mean systemic exposures of etravirine in the presence of lopinavir/ritonavir is similar to the reduction in mean systemic exposures of etravirine in the presence of darunavir/ritonavir, no dose adjustment is required.
- No dose adjustment is required with rilpivirine.
- Co-administration of Kaletra and simeprevir is not recommended.
The Pediatric Use subsection now includes the results of a dosing trial, where at Week 24 efficacy was significantly higher in children receiving twice-daily dosing compared to once-daily dosing. Based on this, Kaletra should not be administered once daily in pediatric patients aged <14 days; the safety, efficacy, and pharmacokinetic profiles of Kaletra in pediatric patients aged <14 days have not been established.
Kaletra is a protease inhibitor indicated for the treatment of HIV infection.
For more information call (888) 463-6332 or visit FDA.gov.