VIRAMUNE XR is an extended-release form of the Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) drug nevirapine, used for the treatment of HIV-1 infection and for perinatal HIV prophylaxis 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. VIRAMUNE XR should not be used in patients with HIV-2 infection, as HIV-2 is resistant to NNRTIs.
Dosing & Administration
Nevirapine is indicated for the treatment of HIV infection in adults and children of any age, including premature neonates, and for prophylaxis of vertical perinatal HIV transmission (off-label). However, VIRAMUNE XR is only appropriate in certain patients, as others require a nevirapine immediate-release formulation. It may be taken with or without food. VIRAMUNE XR has not been studied in patients with liver dysfunction, but nevirapine does not require dosage adjustments for mild liver dysfunction. VIRAMUNE XR should not be used in those with moderate or severe liver impairment (Child-Pugh B or C). VIRAMUNE XR does not require dosage adjustments for renal impairment not requiring dialysis. Dosages and administration instructions are detailed in the product monograph.
VIRAMUNE XR is contraindicated in patients with moderate or severe liver dysfunction (Child-Pugh Class B or C).
VIRAMUNE XR has boxed warnings about hepatotoxicity and skin reactions (see below). A complete list of potential adverse effects is provided in the product monograph.
VIRAMUNE XR has a boxed warning due to reports of severe and even life-threatening cases of hepatotoxicity, especially in the first 18 weeks of use. Recommendations for initial and ongoing monitoring for hepatic events are detailed in the product monograph.
VIRAMUNE XR also comes with a boxed warning about severe, even life-threatening skin toxicity and hypersensitivity reactions, especially during the first 18 weeks of use. Monitoring guidelines are detailed in the product monograph.
All patients who test positive for HIV infection should be screened for comorbid HBV infection. Co-infected patients should be started on an antiretroviral regimen targeting both viruses, regardless of CD4 counts or HBV viral loads. Current HIV treatment guidelines outline drug regimens and prescribing considerations.
Current HIV treatment guidelines recommend testing HIV-positive patients for Hepatitis C virus (HCV), and regular ongoing testing for those at high risk. If HIV/HCV co-infection is identified, consideration should be given to treating both infections concurrently.
VIRAMUNE XR is associated with a large number of drug-drug and herbal interactions. A complete list is provided in the product monograph.
Pregnancy & Lactation
Highly active retroviral combination treatment should be used in all pregnant women. Data from the Antiretroviral Pregnancy Registry (more than 1,200 first trimester exposures) do not show that nevirapine causes major birth defects above baseline. Current guidelines should be consulted when treating pregnant women. VIRAMUNE XR is excreted in breast milk. The CDC recommends that all HIV positive women, treated or untreated, avoid breastfeeding to prevent vertical transmission of the virus.
There is no known antidote for VIRAMUNE XR overdose.
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