Intensive clinical and laboratory monitoring, including liver enzyme tests, is essential during the first 18 weeks of therapy with Viramune® (nevirapine) to detect potentially life-threatening hepatotoxicity and skin reactions. However, liver disease can occur after this period; therefore monitoring should continue at frequent intervals throughout VIRAMUNE treatment. Extra vigilance is warranted during the first 6 weeks of therapy, which is the period of greatest risk of hepatic events and skin reactions.
The optimal frequency of monitoring during the first 18 weeks has not been established. Some experts recommend clinical and laboratory monitoring more often than once a month and, in particular, would include monitoring of liver enzyme tests at baseline, prior to dose escalation, and at 2 weeks after dose escalation. After the initial 18-week period, frequent clinical and laboratory monitoring should continue throughout VIRAMUNE treatment (see WARNINGS AND PRECAUTIONS section in Full Prescribing Information). In some cases, hepatic injury has progressed despite discontinuation of treatment. Patients with signs and symptoms of hepatitis should discontinue VIRAMUNE and seek medical evaluation immediately. If VIRAMUNE is discontinued due to hepatotoxicity, do not restart it.
Patients, particularly women, with increased CD4+ cell count at initiation of VIRAMUNE therapy (>250 cells/mm3 in women and >400 cells/mm3 in men) are at substantially higher risk for development of symptomatic hepatic events, often associated with rash. Patients should be advised that co-infection with hepatitis B or C and/or increased liver enzyme tests at the start of therapy with VIRAMUNE are associated with a greater risk of later symptomatic events (6 weeks or more after starting VIRAMUNE) and asymptomatic increases in AST or ALT (see WARNINGS AND PRECAUTIONS, Hepatotoxicity and Hepatic Impairment in Full Prescribing Information).
Please consult Full Prescribing Information, including boxed WARNING, Medication Guide, and Important Safety Information for VIRAMUNE.
