US approval of paediatric abacavir

On 19 December 2008, FDA approved abacavir (Ziagen) 300 mg scored tablets with corresponding dosing information for paediatric patients weighing 14 kg or more using the scored tablet.

The recommended oral dose of abacavir Oral Solution in HIV-1-infected paediatric 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.

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

Table 1. Dosing Recommendations for abacavir Tablets in Pediatric Patients

Weight (kg) Dosage Regimen Using Scored Tablet Total Daily Dose
AM Dose PM Dose
14 to 21 ½ tablet (150 mg) ½ tablet (150 mg) 300 mg
>21 to <30 ½
tablet (150 mg)
1 tablet (300 mg) 450 mg
≥30 1 tablet (300 mg) 1 tablet (300 mg) 600 mg

The pharmacokinetics of abacavir have been studied after either single or repeat doses of abacavir in 68 paediatric patients. Following multiple-dose administration of abacavir 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 abacavir scored tablet (300 mg) for paediatric 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.

Abacavir is manufactured by GlaxoSmithKline under the trade name Ziagen.

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