• Nevirapine tablets are an NNRTI indicated for combination antiretroviral treatment of HIV-1 infection (1)

Important Considerations:

• Initiation of treatment is not recommended in the following populations unless the benefits outweigh the risks (1, 5.1)
  • adult females with CD4+ cell counts greater than 250 cells/mm3
  • adult males with CD4+ cell counts greater than 400 cells/mm3
• The 14-day lead-in period must be strictly followed; it has been demonstrated to reduce the frequency of rash (2.4, 5.2)

• If any patient experiences rash during the 14-day lead-in period, do not increase dose until the rash has resolved. Do not continue the lead-in dosing regimen beyond 28 days (2.4)
• If dosing is interrupted for greater than 7 days, restart 14-day lead-in dosing (2.4)

• Patients with moderate or severe (Child-Pugh Class B or C, respectively) hepatic impairment (4.1, 5.1, 8.7)
• Use as part of occupational and non-occupational post-exposure prophylaxis (PEP) regimens, an unapproved use (4.2, 5.1)

• Hepatotoxicity:  Fatal and nonfatal hepatotoxicity has been reported. Monitor liver function tests before and during therapy. Permanently discontinue nevirapine if clinical hepatitis or transaminase elevations combined with rash or other systemic symptoms occur. Do not restart nevirapine after recovery. (5.1)
• Rash: Fatal and nonfatal skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis and hypersensitivity reactions, have been reported. Permanently discontinue nevirapine if severe skin reactions or hypersensitivity reactions occur. Check transaminase immediately for all patients who develop a rash in the first 18 weeks of treatment. (5.2)
• Monitor patients for immune reconstitution syndrome and fat redistribution (5.5, 5.6).

• The most common adverse reaction is rash. In adults the incidence of rash is 15% vs. 6% with placebo, with Grade 3/4 rash occurring in 2% of subjects (6.1)
• In pediatric subjects the incidence of rash (all causality) was 21% (6.2)

To report SUSPECTED ADVERSE REACTIONS, contact Mylan Pharmaceuticals Inc. at 1-877-4-INFO-RX (1-877-446-3679) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Coadministration of nevirapine can alter the concentrations of other drugs and other drugs may alter the concentration of nevirapine. The potential for drug interactions must be considered prior to and during therapy (5.4, 7, 12.3)

• Monitor patients with hepatic fibrosis or cirrhosis carefully for evidence of drug-induced toxicity. Do not administer nevirapine to patients with Child-Pugh B or C (5.1, 8.7)
• No dose adjustment is required for patients with renal impairment. Patients on dialysis receive an additional dose of 200 mg following each dialysis treatment (8.6)
• Antiretroviral Pregnancy Registry available (8.1)