Fosamprenavir Pediatric Dosing Approved in U.S. for Ages 4 Weeks to <6 Years
On 27 April 2012, the Food and Drug Administration approved dosing recommendations for use of fosamprenavir (Lexiva) oral suspension in pediatric patients.
Data submitted to FDA included three studies to support a new dosing regimen for fosamprenavir (FOS), with ritonavir (RTV), 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 fosamprenavir label now includes dosing for pediatric patients aged at least 4 weeks to 18 years. The dosage of fosamprenavir should be calculated based on body weight (kg) and not exceed the recommended adult dose.
Twice daily dosage regimens by weight with ritonavir are as follows:
Other sections were updated to include safety and activity data from the three open label trials in pediatric subjects aged at least 4 weeks to 18 years.
The complete updated labeling will be posted soon to on the FDA web site. Fosamprenavir is an HIV protease inhibitor manufactured by GlaxoSmithKline.
Links to external websites are current at time of posting but not maintained.
This article was provided by HIV i-Base. It is a part of the publication HIV Treatment Bulletin. Visit HIV i-Base's website to find out more about their activities, publications and services.
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