Changes to Nevirapine (Viramune) Product Labeling

Patients who experience mild to moderate rash (without constitutional symptoms) during the 200mg QD, 14 day lead-in period should not have their nevirapine dose increased to the recommended 200mg BID until the rash resolves. If the rash does not resolve within 28 days, then an alternative agent should be used. Liver transaminases should be checked immediately in any patient receiving nevirapine who develops a rash. Patients with rash-associated transaminase elevations should be permanently discontinued from nevirapine.

Nevirapine should not be administered to patients with moderate or severe hepatic impairment (Child-Pugh Class B or C). Increased levels of nevirapine may be observed in patients with serious liver disease. Data comes from a study of 46 patients with mild, moderate or severe liver fibrosis; 15% of patients with hepatic fibrosis had nevirapine concentrations that were 2-fold higher than the usual trough concentration.

Pediatric dosing is now based on BSA instead of weight.

See update package insert for nevirapine.

Pam Belperio, PharmD, BCPS
National Public Health Clinical Pharmacist

David Ross, MD, PHD
Director, Clinical Public Health Programs

CC: Ronald O. Valdiserri MD, MPH Chief Consultant, Public Health SHG