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Viramune

March/April 2012

Viramune XR and Viramune

Brand name: Viramune XR and Viramune

Generic name: nevirapine, or NVP

Class: Non-nucleoside reverse transcriptase inhibitor (non-nucleoside, NNRTI, or non-nuke)

Manufacturer: Boehringer Ingelheim, www.viramunexr.com, (800) 274-8651

AWP: $632.68 for XR/month, $133.02 for 240 mL suspension (50 mg/5 mL)

Standard Dose: One 200 mg IR (immediate release) tablet once daily for two weeks, then full dose of one 400 mg once daily for Viramune XR or one 200 mg tablet twice daily for Viramune, with or without food, with no dietary restrictions. Viramune is frequently prescribed as two 200 mg tablets once daily, although once-daily dosing is not FDA approved with the IR formulation; Viramune XR once daily is approved only for adults. Dose for children 15 days or older is 150 mg/m2 once daily for 14 days, then 150 mg/m2 twice daily thereafter, not to exceed 400 mg daily. Take missed dose as soon as possible, unless it is closer in time to your next dose. Do not double up on your next dose. If you interrupt therapy for more than seven days, you will need to restart with 200 mg IR daily for 14 days, followed by 400 mg XR daily or 200 mg IR twice daily. For dialysis patients, an additional dose of 200 mg IR is required after each dialysis. A 50 mg/5 mL oral suspension is also available.

Potential side effects and toxicity: Most common side effects include headache, nausea, vomiting, fever, and rash (reduced with 14-day lead-in dosing). Severe rash, including Stevens-Johnson syndrome, while rare, can be life-threatening; notify your health care provider immediately. Seek medical attention right away if you experience blistering, mouth sores, conjunctivitis (redness or inflammation of the eye, or pink eye, which if untreated may result in permanent vision loss), swelling, muscle or joint aches, fever, or malaise (general ill feeling). Do not increase dose if rash develops during dose escalation or if it is accompanied by the conditions listed above. Once-daily lead-in dose should not exceed 28 days. An alternative drug should be considered at this time. An increase in liver enzyme levels has been observed and in rare instances, hepatitis has developed. In such cases, it may be necessary to stop taking Viramune (either formulation) until liver function returns to normal. Permanently discontinue it if abnormalities return. Rarely, severe and life-threatening liver damage, including fatal cases, has occurred. Women with CD4 counts greater than 250 T-cells, including pregnant women have the highest risk of serious liver damage, though men with more than 400 T-cells are also at risk. The package insert says Viramune or Viramune XR should not be started in these groups unless the benefit outweighs the risk. The highest risk period is within the first six weeks of treatment, but patients should be monitored closely for the first 18 weeks. See chart for potential drug class side effects.

Potential drug interactions: Non-nukes interact with many other drugs. See package insert for the most complete list. Tell your provider or pharmacist about all medications, herbs, and supplements you are taking or thinking of taking, prescribed or not. Do not take with Atripla, Complera, Edurant, Intelence, Rescriptor, Reyataz, Sustiva, or St. John's wort. Rifampin should not be used with Viramune; Mycobutin (rifabutin) is the recommended alternative to rifampin for tuberculosis treatment. Use with caution with midazolam, triazolam, cisapride, fluconazole, or Cordarone, lidocaine or disopyramide, ethosuximide, clonazepam, calcium channel blockers (Procardia and others), immunosuppressants (including transplant drugs), and Coumadin (warfarin). Do not use with Biaxin or Nizoral. Viramune decreases methadone levels; dose adjustment may be necessary to avoid withdrawal symptoms. Can reduce levels of protease inhibitors; dose adjustment may be needed if they are taken together. Kaletra should be increased to three tablets twice a day in treatment-experienced people. Use caution with anti-convulsants: Dilantin, phenobarbital, and Tegretol. Effectiveness of birth control pills may be decreased; consider the use of alternative or additional contraception. During the first six weeks of therapy, prednisone should be avoided; it can cause increased severity and incidence of rash.

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More information: The once-daily Viramune XR was FDA approved in 2011, but many providers already prescribe once-daily dosing with the old formulation. The regular Viramune (IR) formulation may go generic (nevirapine) this year. Monitor liver function and signs of rash during first six months. Do not ignore yellowing of your eyes or skin, as this may be a sign of a severe liver effect. Studies show that nevirapine 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. Viramune should not be used for PEP (post-exposure prophylaxis). Viramune has been shown to have a positive impact on triglycerides and cholesterol levels. When taken 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 taken alone. The use of at least one other HIV drug helped to cut down the incidence of resistance. Single- or double-dose Viramune may be used for babies born to HIV-positive mothers. Mothers should not breast-feed their infants while taking Viramune. See package insert for more complete information on potential side effects and interactions.


Doctor's Comments

Viramune is a component of the vast majority of first-line regimens worldwide, in part because of the low cost of generic nevirapine. It has not been as popular in the United States, however, in part because of the stronger clinical data with Sustiva, but also because of its greater early toxicity. It's listed as an "acceptable" NNRTI in the DHHS guidelines and an "alternative" in the IAS-USA guidelines. Viramune can cause skin rashes and liver toxicity during the first few weeks, which can be severe and even life-threatening. The risk is greatest when it's started in people with high CD4 counts: above 250 in women and above 400 in men. Below those CD4 thresholds, the risk is low, and the long-term safety is excellent, with less lipid elevation than with Sustiva. Viramune should be started at half-dose (200 mg once daily) and increased to the full dose (200 mg twice daily) after two weeks only if there is no rash or liver enzyme elevation. Viramune XR, a new 400 mg single tablet, once-daily formulation, was approved last year. Compared to Sustiva, resistance to Viramune is somewhat more likely to cause cross-resistance to Intelence.

-- Joel Gallant, M.D., M.P.H.


Activist's Comments

The softer, gentler non-nuke, Viramune is now a "once-daily" XR (extended release) formula. This reformulation helped this drug maintain some market share from moving over to the generic version. Clinical studies showed that people who were undetectable on another regimen could safely switch to Viramune. Many in Florida have switched safely to this lipid-friendly drug (better at maintaining normal levels of cholesterol and triglycerides), so this drug has a niche for those who can't tolerate Sustiva-based regimens or Atripla. However, with so many new drugs with fewer pills and fewer side effects, I have a feeling this drug's day as a mainstay are numbered.

-- Joey Wynn


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