VIRAMUNE (nevirapine) is a Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) drug, used for the treatment of human immunodeficiency virus (HIV-1) infection in combination with other antiretroviral drugs. It works by binding to the HIV enzyme reverse transcriptase and blocking its catalytic site, thereby disrupting viral replication.
Dosing & Administration
VIRAMUNE can be used in adults and pediatric patients 15 days and older. There is a 14-day lead-in period that must be strictly followed with this product. This is to be followed due to the frequency of rash. The details of adjustment based on age within this regimen can be found in the package insert. VIRAMUNE comes in tablet form and oral suspension.
VIRAMUNE is contraindicated in patients with moderate or severe liver dysfunction (Child-Pugh Class B or C).
Rash is the most common adverse reaction with this product.
Fatal and non-fatal hepatotoxicity and skin reactions have been reported in patients using VIRAMUNE. The patient should be discontinued if clinical hepatitis or transaminase elevations combined with rash or other systemic symptoms occur. Monitoring during the first 18 weeks of therapy is important with extra vigilance during the first 6 weeks of therapy. In addition, patients should be monitored for immune reconstitution syndrome and fat redistribution. Further information can be found in the package insert.
VIRAMUNE is associated with a number of drug-drug interactions, and prescribers should familiarize themselves with the list provided in the package insert.
Pregnancy & Lactation
Regardless of pregnancy status, women with cluster of differentiation (CD4) cell counts greater than 250 cells/mm should not start VIRAMUNE unless the benefit outweighs the risk. There is a pregnancy exposure registry that has been set up to monitor pregnancy outcomes in women exposed to nevirapine during pregnancy.
The Centers for Disease Control and Prevention (CDC) recommend that HIV-1 infected mothers in the United States not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection. There is potential for HIV-1 transmission in HIV-negative infants and the potential of developing viral resistance in HIV-positive infants. Nevirapine has been shown to be present in human milk. There is limited information about the effects of nevirapine on the breastfed infant. There is no information existing on the effects of nevirapine on milk production.
There is no known antidote for VIRAMUNE overdose. Reported cases have shown that events subsided following discontinuation of VIRAMUNE.
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