ANTIRETROVIRALS

US label changes for nevirapine paediatric solution

On 24 June 2008, FDA approved labeling changes to the Viramune (nevirapine) oral solution and tablets to reflect various updates, including:

Dosing recommendations for paediatric patients 15 days to 2 months of age.
Dose recommendations for all pediatric age groups are now based on body surface area (BSA) instead of weight-based dosing. Studies were conducted comparing weight-based dosing and BSA-based dosing. While comparable drug concentrations are achieved with either method, BSA dosing allows for smoother dose transitions between pediatric age groups and is therefore preferred.
Addition of data from a pharmacokinetic hepatic impairment study
Revision of the recommendation that nevirapine not be administered to patients with severe hepatic impairment to a recommendation that nevirapine not be administered to patients with moderate (Childs Pugh B) or severe (Childs Pugh C) hepatic impairment.
Revision of recommendations for the occurrence of rash during the once daily lead-in phase of dosing. The label now states that lead-in dosing should not be extended beyond 28 days of dosing.

Source:
FDA list serve (27 June 2008).
http://www.fda.gov/oashi/aids/listserve/listserve2008.html#62708