Safety-related Changes to the Nevirapine (Viramune®) Label

The nevirapine label has been revised several times overthe last two years to include more information on liver toxicityassociated with long-term nevirapine use. Based on a higherobserved risk of serious liver toxicity in patients with elevatedCD4+ cell counts prior to initiation of therapy, the “Indicationsand Usageâ€? section of the Viramune® label now recommendsagainst starting nevirapine treatment in women with CD4counts > 250 cells/mm3 and men with CD4 counts > 400cells/mm3, unless the benefits clearly outweigh the risks. Regarding symptomatic nevirapine liver toxicity, it is importantto note the following.