Nevirapine indications and usage
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
Indications And Usage
VIRAMUNE XR is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in children 6 to less than 18 years of age [see Clinical Studies (14.1, 14.2)].
Additional important information regarding the use of VIRAMUNE XR for the treatment of HIV-1 infection:
- Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, 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 [see Boxed Warning and Warnings and Precautions (5.1)].
- The 14-day lead-in period with immediate-release VIRAMUNE dosing must be strictly followed; it has been demonstrated to reduce the frequency of rash [see Dosage and Administration (2.5) and Warnings and Precautions (5.2)].
- If rash persists beyond the 14-day lead-in period with immediate-release VIRAMUNE, do not begin dosing with VIRAMUNE XR. The lead-in dosing with 200 mg once-daily immediate-release VIRAMUNE should not be continued beyond 28 days, at which point an alternative regimen should be sought.[1]
References
- ↑ "VIRAMUNE (NEVIRAPINE) TABLET, EXTENDED RELEASE [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]". Retrieved 10 January 2014.
Adapted from the FDA Package Insert.