FDA Approves New Pediatric Dosing Recommendations for Fosamprenavir (Lexiva)
“On April 27, 2012, the Food and Drug Administration approved dosing recommendations for use of Lexiva (fosamprenavir) oral suspension in pediatric patients.
“Data submitted to FDA included three studies to support a new dosing regimen for Lexiva, with ritonavir, in combination with other antiretroviral drugs, for the treatment of HIV-1 infection in pediatric patients from at least 4 weeks to less than 6 years of age.
“The Lexiva label now includes dosing for pediatric patients aged at least 4 weeks to 18 years. The dosage of Lexiva should be calculated based on body weight (kg) and not exceed the recommended adult dose. …
“For pediatric patients, pharmacokinetic and clinical data:
- do not support once-daily dosing of LEXIVA alone or in combination with ritonavir
- do not support administration of LEXIVA alone or in combination with ritonavir for protease inhibitor-experienced children younger than 6 months of age
- do not support twice-daily dosing of LEXIVA without ritonavir in pediatric patients younger than 2 years of age”
The updated label will be available at the FDA website.
More information is available:
NIH Study Suggests Tenofovir Use During Pregnancy Does Not Affect Infant Size or Birth Weight
“Infants born to women who used the anti-HIV drug tenofovir as part of an anti-HIV drug regimen during pregnancy do not weigh less at birth and are not of shorter length than infants born to women who used anti-HIV drug regimens that do not include tenofovir during pregnancy, according to findings from a National Institutes of Health network study. However, at 1 year of age, children born to the tenofovir-treated mothers were slightly shorter and had slightly smaller head circumference — about 1 centimeter each, on average — than were infants whose mothers did not take tenofovir.
“The study authors described the findings as reassuring, noting that the study did not identify any serious safety concerns during pregnancy for tenofovir. … The researchers called for additional studies to follow the children as they grow and develop, to identify any potential long term effects of the treatment. …
“The study included 2,000 U.S. infants born to HIV-positive mothers between 2003 and 2010. The researchers collected data for the infants’ size relative to their gestational age (time they had spent in the womb), their birth weight, length at birth, and the circumference of their head. The researchers recorded similar measurements when the child was 1 year old.
“They found that mothers taking tenofovir in combination with other anti-HIV medications and mothers on anti-HIV drug combinations that did not include tenofovir gave birth to infants who were smaller, on average, than infants born to HIV-negative mothers. However, they did not find significant differences between infants from the two groups of HIV-positive mothers.
“The tenofovir-exposed infant's smaller average size and head circumference at one year of age suggests tenofovir could have a delayed effect on growth.”
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