December 19, 2008
On December 19, FDA approved Ziagen (abacavir) 300 mg scored tablets with corresponding dosing information for pediatric patients weighing 14 kg or more using the scored tablet.
The Dosage and Administration section and Clinical Pharmacology sections were revised as follows:
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.
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.