Nevirapine Tablets and Rash

Nevirapine can cause severe, life-threatening skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity reactions characterized by rash, constitutional findings, and organ dysfunction including hepatic failure. Fatalities in association with these reactions have been reported. The first 6 weeks of therapy is the period of greatest risk, and intense monitoring is recommended during the first 18 weeks. In controlled clinical trials, Grade 3 and 4 rashes were reported during the first 6 weeks in 1.5 % of nevirapine-treated patients compared to 0.1% of placebo subjects. Patients who develop signs or symptoms of severe skin reactions or hypersensitivity reactions possibly related to nevirapine at any time during therapy must discontinue the drug and seek medical attention immediately. Because nevirapine-induced hepatitis and hepatic failure may be associated with hypersensitivity reactions, liver function tests should be performed in these patients as well as all patients who develop a rash within the first 18 weeks of treatment. Nevirapine should be permanently discontinued if clinical hepatitis or transaminase elevations combined with rash or other systemic symptoms occur, and should not be restarted after recovery. Nevirapine therapy should also not be restarted following severe skin or hypersensitivity reactions or a rash that is accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, eosinophilia, granulocytopenia, lymphadenopathy, or renal dysfunction. During the initial 2-week lead-in period of 200 mg/day (4 mg/kg/day in pediatric patients), the dosage of nevirapine should not be increased if any rash occurs. Dose escalation should only be attempted after the rash resolves.