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Fosamprenavir Pediatric Dosing Approved in U.S. for Ages 4 Weeks to <6 Years

May/June 2012

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:


Less than 11 kg FOS 45 mg/kg plus RTV 7 mg/kg
11 kg to less than 15 kg FOS 30 mg/kg plus RTV 3 mg/kg
15 kg to less than 20 kg FOS 23 mg/kg plus RTV 3 mg/kg
Greater than and equal to 20 kg FOS 18 mg/kg plus RTV 3 mg/kg


Alternatively, protease inhibitor naive children 2 years of age and older can be administered fosamprenavir (without ritonavir) 30 mg/kg twice daily. Fosamprenavir should only be administered to infants born at 38 weeks gestation or greater and who have attained a post-natal age of 28 days. For pediatric patients, pharmacokinetic and clinical data:

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.

www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

Links to external websites are current at time of posting but not maintained.




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