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Brand Name: Viramune
Common Name: nevirapine (NVP)
Class: non-nucleoside analog (also called non-nucleoside reverse transcriptase inhibitor, NNRTI, or non-nuke)
Standard Dose: One 200 mg tablet daily for two weeks, then full dose of one 200 mg tablet twice daily, no food restrictions, may be taken with or without food; frequently prescribed as two 200 mg tablets once a day, although once-daily dosing is not FDA-approved. Take missed dose as soon as possible but do not double up on your next dose. For dialysis patients, an additional dose of 200 mg is required after each dialysis.
AWP: $443.87 / month
Manufacturer contact: Boehringer-Ingelheim,
www.viramune.com, 1 (800) 274–8651
AIDSInfo:1 (800) HIV–0440 (448–0440), www.aidsinfo.nih.gov
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| Potential side effects and toxicity: |
Most common side effects include headache, nausea, vomiting, fever and rash. 14-day lead-in dosing reduces the frequency of rash. A serious side effect of the NNRTI class is rash, which can be life-threatening. If you experience blistering, mouth sores, conjunctivitis (redness or inflammation of eye, or pink eye, which if untreated may result in permanent vision loss), swelling, muscle or joint aches, fever or general malaise (general ill feeling), you may need to stop the medications so seek medical attention immediately. Do not increase dose if rash develops during dose escalation or if you develop any rash accompanied by the above listed conditions. An increase in liver enzyme levels has been observed and in rare instances the development of hepatitis. May need to stop taking nevirapine until liver function returns to normal. Permanently discontinue if abnormalities return. Although rare, severe and life-threatening skin reactions and hepatotoxicity (liver damage), including fatal cases of each, have occurred. Women with CD4 counts greater than 250 T-cells, including pregnant women, and men with more than 400 T-cells have a higher risk of serious hepatotoxicity (liver damage), with women being at greater risk. The package insert says Viramune should not be started in these groups unless the benefit outweighs the risk. But the liver damage can happen to anybody. The highest risk period is within the first six weeks of treatment, but patients should be monitored closely for the first 18 weeks.
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| Potential drug interactions: |
| Caution should be used with Versed, Halcion, fluconazole, or ergot medications, used for migraine headaches (Wigraine, Methergine, and Cafergot), Cordarone, lidocaine or disopyramide, carbamazepine, ethosuxomide, or clonazepam, calcium channel blockers (Procardia, diltiazem, verapamil), immunosuppressants, or the blood thinner Coumadin. Do not use with Biaxin or ketoconazole. Viramune decreases methadone levels; dosing adjustment may be necessary to avoid withdrawal symptoms. Viramune reduces levels of protease inhibitors. If they are taken at the same time the doses must be increased. Kaletra should be increased to three tablets twice-a-day. Viramune interacts with rifampin, requiring dose adjustment, and caution is advised with rifabutin. The effectiveness of birth control pills may be decreased; women and their male partners should consider the use of alternative contraception methods with barrier. During the first six weeks of therapy, prednisone should be avoided. It can cause increased severity and incidence of rash. Avoid St. John’s wort, due to decreased levels of Viramune. |
| Tips: |
Monitor liver function tests and signs of rash during first six months. The increased period of risk for liver injury is primarily in the first 18 weeks of taking Viramune. Do not ignore yellowing of your eyes or skin, as this may be a sign of a severe liver effect. Studies show that Viramune crosses the blood-brain barrier to a useful degree, which may be beneficial for patients at risk for neurological damage (such as dementia) from HIV. Lead-in dosing has been shown to lessen the risk of rash. If at any time of treatment you stop Viramune for seven days, you will need to start at the lower dose for two weeks and then increase back up to twice-daily dosing. Viramune has also been shown to have a positive impact on triglycerides and cholesterol levels. When given around the time of labor Viramune has demonstrated effectiveness in preventing the transmission of HIV from mother to child, but there was an increase in HIV drug resistance when given alone. The use of at least one other HIV drug helped to cut down the incidence of resistance. Single or two dose Viramune may be used for babies born to HIV-positive mothers. Mothers should not breastfeed their infants while taking Viramune.
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| Doctor |
| Nevirapine (NVP) is not as widely used as efavirenz due to its twice-a-day dosing, side effect profile, and lack of data from contemporary studies comparing it in combination with newer RTI backbones (such as tenofovir plus FTC) to gold standard regimens. Data from earlier studies and from its widespread international use (often as a generic medication) affirm its potency and reasonable tolerability. There may be a genetic predisposition to serious (even life threatening) hypersensitivity reactions or immune-hepatitis which, if worked out in future studies, may translate into identification of populations at low risk for serious reactions. For now, however, no reliable algorhythm exists that allows for prospective identification of persons at low or high risk for serious reactions, thus limiting its use in the U.S. Advantages of NVP compared to efavirenz include lower cost, demonstrated safety in pregnancy, and less effect on lipid/metabolic parameters. Data supporting once-a-day dosing are not convincing and studies using once daily dosing coupled with use of drugs with longer half-lives (e.g., Truvada) are needed to assess the role of NVP.—Keith Henry, MD |
| Activist |
| The first effective drug in its class, Viramune hit the market with a bang. Without the central nervous system side effects of its later NNRTI competitor drug Sustiva, Viramune was, and is, a terrific option for people who want to avoid taking a PI. Unfortunately, as with all HIV drugs, there are a few caveats. Viramune has a tendency to cause a rash in its early use, which for the most part can be treated through with things like Benadryl. The bigger issue with Viramune is the potential for liver toxicity. Women are at greater risk of developing liver toxicity. It is recommended that women with high T-cells not start this drug. It should also be noted that women who have been on the drug for a while, and whose T-cells are above 250, do not need to stop this drug, but should be monitored carefully by their physician. Single-dose Viramune was found to be very effective in preventing mother-to-child transmission, and is commonly used now in the developing world for that purpose, but the full ramifications of widespread NNRTI resistance among women in the developing world is not yet completely understood. For now, until we have better access to other therapies globally, the benefits outweigh the risks.—Cathy Olufs |
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Back to 2007 Drug Guide