New Pediatric Lexiva Dosing Regimen for Patients From at Least 4 Weeks to Less Than 6 Years of Age
April 27, 2012
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.
Twice daily dosage regimens by weight with ritonavir are as follows:
Less than 11 kg: Lexiva 45 mg/kg plus ritonavir 7 mg/kg
Alternatively, protease inhibitor naive children 2 years of age and older can be administered Lexiva (without ritonavir) 30 mg/kg twice daily.
Lexiva should only be administered to infants born at 38 weeks gestation or greater and who have attained a post-natal age of 28 days.
Sections 6: Adverse Reactions, 8.4 Pediatric Use, 12.3 Pharmacokinetics and 14 Clinical Studies 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 Drugs@FDA, on the FDA web site.
This article was provided by U.S. Food and Drug Administration. Visit the FDA's website to find out more about their activities and publications.
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