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New pediatric Lexiva dosing regimen for patients from at least 4 weeks to less than 6 years of age

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:

  • for protease inhibitor-naïve pediatric patients (greater than or equal to 4 weeks of age) and   
  • for protease inhibitor-experienced pediatric patients greater than or equal to 6 months of age. (Lexiva plus ritonavir is not recommended for protease inhibitor experienced pediatric patients less than 6 month of age.)

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

Alternatively, protease inhibitor naïve 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.

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

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.
Lexiva is an HIV protease inhibitor manufactured by GlaxoSmithKline

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration