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).