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 following has been added to provide the results of the etravirine and rilpivirine drug interaction trials:

  • 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.

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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.

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