INDICATION AND IMPORTANT SAFETY INFORMATION

VIRAMUNE is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on one principal clinical trial that demonstrated prolonged suppression of HIV-RNA and two smaller supportive studies.

Life-threatening and fatal hepatotoxicity has occurred in patients receiving VIRAMUNE. Any patient can experience hepatic events; however, female gender and higher CD4 counts at initiation of therapy place patients at greater risk. Women, including pregnant women, with CD4+ cell counts >250 cells/mm³ are at the greatest risk. VIRAMUNE 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. Hepatic events are often associated with rash. Hepatic failure has also been reported in patients without HIV taking VIRAMUNE for post-exposure prophylaxis (PEP). Use of VIRAMUNE for occupational and non-occupational PEP is contraindicated.

Life-threatening and fatal skin reactions have also occurred, including Stevens-Johnson Syndrome, toxic epidermal necrolysis and hypersensitivity reactions characterized by rash, constitutional findings, and organ dysfunction.

Patients should be intensively monitored for hepatic and skin reactions for the first 18 weeks of therapy with extra vigilance during the first 6 weeks, which is the period of greatest risk. Frequent monitoring should be performed throughout therapy with VIRAMUNE.

VIRAMUNE should be discontinued and not restarted in patients who develop signs or symptoms of hepatitis, hypersensitivity, severe skin reactions or any rash accompanied by constitutional findings. In some cases, hepatic injury has progressed despite discontinuation of treatment.

Patients with either hepatic fibrosis or cirrhosis should be monitored carefully for evidence of drug induced toxicity. VIRAMUNE should not be administered to patients with moderate or severe (Child Pugh Class B or C, respectively) hepatic impairment.

Other common side effects include nausea, fatigue, fever, headache, vomiting, diarrhea, abdominal pain, and myalgia. Immune reconstitution syndrome has been reported in patients treated with combination ARV therapy.

The dose of VIRAMUNE for adults is one 200-mg tablet daily for the first 14 days (this has been shown to reduce the frequency of rash), followed by one 200-mg tablet twice daily. Any patient experiencing rash during the 14-day lead-in period should not increase dose until the rash has resolved. The lead-in dosing regimen should not be continued beyond 28 days.