FDA approves new paediatric dose of nelfinavir

Based on five clinical paediatric studies, the US Food and Drug Administration (FDA) has approved new dosing recommendations in patients two years of age and older who are receiving nelfinavir. In patients less than two years of age, nelfinavir was found to be safe at the doses studied, but a reliably effective dose could not be established.

The recommended oral dose of nelfinavir oral powder or 250 mg tablets is 45 to 55 mg per kilogram of weight (mg/kg) twice-daily or 25 to 35 mg/kg three-times-daily. All doses should be taken with a meal. Doses higher than the maximum adult dose of 2,500 mg per day have not been studied in children.

The following points are highlighted in the paediatric use section of the label:

  • In paediatric patients two years of age and older receiving nelfinavir as part of triple combination antiretroviral therapy in randomised studies, the proportion of patients achieving an HIV RNA level less than 400 copies/mL through 48 weeks ranged from 26% to 42%.
  • Response rates in children less than two years of age appeared to be poorer than those in patients two years of age and older in some studies.
  • Highly variable drug exposure remains a significant problem in the use of nelfinavir in paediatric patients. Unpredictable drug exposure may be exacerbated in paediatric patients because of increased clearance compared to adults and difficulties with compliance and adequate food intake with dosing.

Source: Food and Drug Administration

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