On 25 March 2011, the FDA approved an extended release formulation of nevirapine XR (Viramune-XR) 400 mg extended release tablet.<\/p>\n
The approval is based on one principal clinical trial (1100.1486) that demonstrated prolonged suppression of HIV-1 RNA through 48-weeks, and a supportive trial (1100.1526).<\/p>\n
Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled studies, nevirapine should not be initiated in adult females with CD4+ cell counts greater than 250 cells\/mm3 or in adult males with CD4+ cell counts greater than 400 cells\/mm3 unless the benefit outweighs the risk<\/p>\n
The 14-day lead-in period with immediate-release nevirapine 200 mg daily dosing must be strictly followed; it has been demonstrated to reduce the frequency of rash.<\/p>\n
If rash persists beyond the 14-day lead-in period with immediate-release nevirapine, do not begin dosing with nevirapine XR. The lead-in dosing with 200 mg once-daily should not be continued beyond 28 days, at which point an alternative regimen should be sought.<\/p>\n
Comment<\/strong><\/p>\n Filing in Europe for nevirapine XR has already taken place with a decision from the EMA expected in the third quarter of 2011.<\/strong><\/p>\n Source: FDA list serve<\/p>\n