Overview

Information For Healthcare Professionals

This section provides important information about Viramune^® (nevirapine) as well as links to patient support resources and information online about HIV/AIDS.

INDICATIONS AND USAGE

Viramune^® (nevirapine) 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 (BI 1090) that demonstrated prolonged suppression of HIV-RNA and two smaller supportive studies, one of which (BI 1046) is described below.

Additional important information regarding the use of VIRAMUNE for the treatment of HIV-1 infection:

• Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled studies, 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 (see WARNINGS).
• The 14-day lead-in period with VIRAMUNE 200 mg daily dosing has been demonstrated to reduce the frequency of rash (see WARNINGS; DOSAGE AND ADMINISTRATION).

Important Safety Information

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. 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. Women, including pregnant women, with CD4+ cell counts >250 cells/mm³ are at the greatest risk.

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 or severe skin reactions. In some cases, hepatic injury has progressed despite discontinuation of treatment.

Other common side effects include nausea, fatigue, fever, headache, vomiting, diarrhea, abdominal pain, and myalgia. Redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy. Immune reconstitution syndrome has been reported in patients treated with combination ARV therapy.