The Dosage and Administration and the Clinical Pharmacology sections were revised as follows:

2 DOSAGE AND ADMINISTRATION

2.2 Pediatric Patients
The recommended oral dose of ZIAGEN Oral Solution in HIV‑1‑infected pediatric patients >3 months of age is 8 mg/kg twice daily (up to a maximum of 300 mg twice daily) in combination with other antiretroviral agents.

ZIAGEN is also available as a scored tablet for HIV‑1‑infected pediatric patients weighing >14 kg for whom a solid dosage form is appropriate. Before prescribing ZIAGEN Tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow ZIAGEN Tablets, the oral solution formulation should be prescribed. The recommended oral dosage of ZIAGEN Tablets for HIV‑1‑infected pediatric patients is presented in Table 1.

12 CLINICAL PHARMACOLOGY

12.3 Pharmacokinetics

Pediatric Patients: The pharmacokinetics of abacavir have been studied after either single or repeat doses of ZIAGEN in 68 pediatric patients. Following multiple‑dose administration of ZIAGEN 8 mg/kg twice daily, steady-state AUC _(0-12 hr) and Cmax were 9.8 ± 4.56 mcg•hr/mL and 3.71 ± 1.36 mcg/mL (mean ± SD), respectively [see Use in Specific Populations (8.4)]. In addition, to support dosing of Ziagen scored tablet (300 mg) for pediatric patients 14 – > 30 kg, analysis of actual and simulated pharmacokinetic data indicated comparable exposures are expected following administration of 300 mg scored tablet and the 8 mg/kg dosing regimen using oral solution.

Ziagen. a member of the Nucleoside Reverse Transcriptase Inhibitor (NRTI) class, is a product of  GlaxoSmithKline.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration