martes, 30 de junio de 2015

Kaletra (lopinavir/ritonavir) product labeling was updated

The Kaletra (lopinavir/ritonavir) product labeling was updated to include drug-drug interaction information with etravirine, rilpivirine and simeprevir and to update the Use in Specific Populations, Pediatric Use subsection with information from a clinical trial that investigated the use of a once daily dosing regimen. The specific changes to the product labeling are summarized below.
The following additions were made to section 7 Drug Interactions, Table 13. Section 12.3 Clinical Pharmacology, Table 14 and 15 was updated to provide the results of the etravirine and rilpivirine drug-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
Section  8.4 Pediatric Use was updated to include the results of a once daily versus twice daily dosing trial as summarized below.
The safety, efficacy, and pharmacokinetic profiles of KALETRA in pediatric patients below the age of 14 days have not been established. KALETRA should not be administered once daily in pediatric patients.
A prospective multicenter, randomized, open-label study evaluated the efficacy and safety of twice-daily versus once-daily dosing of KALETRA tablets dosed by weight as part of combination antiretroviral therapy (cART) in virologically suppressed HIV-1 infected children (n=173). Children were eligible when they were aged < 18 years, ≥ 15 kg in weight, receiving cART that included KALETRA, HIV-1 ribonucleic acid (RNA) < 50 copies/mL for at least 24 weeks and able to swallow tablets. At week 24, efficacy (defined as the proportion of subjects with plasma HIV-1 RNA less than 50 copies per mL) was significantly higher in subjects receiving twice daily dosing compared to subjects receiving once daily dosing. The safety profile was similar between the two treatment arms although there was a greater incidence of diarrhea in the once daily treated subjects.
 You can view the complete label at drugs@fda or dailymed.
Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration

Kimberly Struble
Division of Antiviral Products
Food and Drug Administration

Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration

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