Classes
DEA Class; Rx
Common Brand Names; NVP, Viramune, Viramune XR
- HIV, NNRTIs
Description
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
Indications
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
Contraindications
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
Adverse Effects
- 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
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
400 mg/day PO.
400 mg/day PO.
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.
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.
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.
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.
How supplied
Nevirapine
oral suspension
- 10mg/mL
tablet, immediate-release
- 200mg
tablet, extended-release
- 100mg
- 400mg
