Skip to content

Nevirapine

    Brands

    DEA Class; Rx

    Common Brand Names; NVP, Viramune, Viramune XR

    • HIV, NNRTIs

    Non-nucleoside reverse transcriptase inhibitor
    Used for human immunodeficiency virus (HIV) infection and for perinatal HIV prophylaxis in combination with other antiretroviral agents
    Use is associated with serious rash and sometimes fatal hepatotoxicity

    Indicated for treatment of HIV-1 infection in combination with other antiretrovirals; also used for prevention of maternal-fetal HIV transmission in women with no prior antiretroviral treatment

    Hypersensitivity

    Moderate or severe hepatic impairment (Child-Pugh class B or C)

    Coadministration with drugs (eg, CYP inducers) where significant decreases in nevirapine plasma concentrations may occur, which may result in loss of virologic response and possible resistance and cross-resistance to other NNRTIs

    Use as part of postexposure prophylaxis (PEP) regimens

    • Diarrhea (15-20%)
    • Rash (15-20%)
    • Headache (11%)
    • Neutropenia (10-11%)
    • Fever (8-11%)
    • Ulcerative stomatitis (4%)
    • Increased LFTs (2-4%)
    • Abdominal pain (2%)
    • Paresthesia (2%)
    • Nausea
    • Anemia
    • Peripheral neuropathy
    • Myalgia

    Do not restart therapy following severe skin rash, skin rash combined with increased transaminases or other symptoms, or hypersensitivity reaction

    Risk of severe, life threatening skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity

    Discontinue if severe rash or any rash accompanied by constitutional findings occurs

    Risk of immune reconstitution syndrome if used in combination with other antiretroviral drugs

    Redistribution/accumulation of body fat may occur (cushingoid appearance)

    Limited human data are insufficient to determine risk of infertility in humans; based on results from animal fertility studies conducted in rats, therapy may reduce fertility in females of reproductive potential; not known if these effects on fertility are reversible

    There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to nevirapine during pregnancy

    The Centers for Disease Control and Prevention recommend that HIV-1 infected mothers in the United States not breastfeed infants to avoid risking postnatal transmission of HIV-1 infection

    Adults

    400 mg/day PO.

    Geriatric

    400 mg/day PO.

    Adolescents

    BSA 1.17 or more: 300 mg/m2/day (Max: 400 mg/day) PO for immediate release formulations; 400 mg/day PO for extended-release tablets.
    BSA less than 1.17: 300 mg/m2/day PO for immediate release formulations; extended-release tablets not indicated.

    Children

    8 to 12 years and BSA 1.17 or more: 300 mg/m2/day (Max: 400 mg/day) PO for immediate release formulations; 400 mg/day PO for extended-release tablets.
    8 to 12 years and BSA less than 1.17: 300 mg/m2/day PO for immediate release formulations; extended-release tablets not indicated.
    6 to 7 years and BSA 1.17 or more: for immediate release formulations, doses up to 400 mg/m2/day (Max: 400 mg/day) PO are recommended in the HIV guidelines, although 300 mg/m2/day PO is recommended in the FDA-approved labeling. 400 mg/day PO for extended-release tablets.
    6 to 7 years and BSA less than 1.17: for immediate release formulations, doses up to 400 mg/m2/day PO are recommended in the HIV guidelines, although 300 mg/m2/day PO is recommended in the FDA-approved labeling. Extended-release tablets not indicated.
    1 to 5 years: for immediate release formulations, doses up to 400 mg/m2/day PO are recommended in the HIV guidelines, although 300 mg/m2/day PO is recommended in the FDA-approved labeling. Safety and efficacy of extended-release tablets not established.

    Infants

    For immediate release formulations, 12 mg/kg/day PO is recommended in the HIV guidelines for perinatal prophylaxis and treatment, although 300 mg/m2/day PO is the FDA-approved dose for treatment. Safety and efficacy of other formulations have not been established.

    Neonates

    15 days and older: for immediate release formulations, 8 mg/kg/day PO for premature neonates 32 to 33 weeks gestation and 12 mg/kg/day PO for premature neonates 34 weeks gestation and older is recommended in the HIV guidelines for perinatal prophylaxis and treatment, although 300 mg/m2/day PO is the FDA-approved dose for treatment. Safety and efficacy of other formulations have not been established.
    7 to 14 days: Safety and efficacy have not been established; however, 4 mg/kg/day PO for premature neonates 32 to 33 weeks gestation and 12 mg/kg/day PO for premature neonates 34 weeks gestation and older is recommended in the HIV guidelines for perinatal prophylaxis and treatment.
    0 to 6 days: Safety and efficacy have not been established; however, 3 doses are recommended for perinatal prophylaxis (8 mg PO once daily for weight 1.5 to 2 kg; 12 mg PO once daily for weight more than 2 kg); 4 mg/kg/day PO for premature neonates 32 to 33 weeks gestation, 8 mg/kg/day PO for premature neonates 34 to 36 weeks gestation, and 12 mg/kg/day PO for neonates 37 weeks gestation and older also recommended in the HIV guidelines for perinatal prophylaxis and treatment.

    Nevirapine

    oral suspension

    • 10mg/mL

    tablet, immediate-release

    • 200mg

    tablet, extended-release

    • 100mg
    • 400mg