What
is Viramune?
•
Viramune is an anti-HIV medication. It is in a category of HIV medicines called
non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Viramune prevents HIV from entering the nucleus of healthy T-cells. This prevents
the cells from producing new virus and decreases the amount of virus in the body.
•
Viramune, manufactured by Boehringer-Ingelheim, was approved by the U.S. Food
and Drug Administration for the treatment of HIV in 1996.
•
Viramune must be used in combination with other drugs to treat HIV. It is usually
combined with two nucleoside analogues.
Important
Safety Information
•
Viramune® (nevirapine) does not cure HIV or AIDS, and has not been shown to
reduce the risk of passing HIV to others through sexual contact or blood contamination. •
VIRAMUNE can cause severe liver disease and skin reactions that can cause death.
These reactions occur most often during the first 18 weeks of treatment, but can
occur later. Ask your healthcare provider about how to recognize symptoms of skin
and liver problems. Stop taking VIRAMUNE if you have any of these reactions. Do
not restart VIRAMUNE if you experience any of these reactions. Call your healthcare
provider immediately if you have any of these reactions. •
Any patient can experience liver problems with VIRAMUNE but women and patients
who have higher CD4 counts when they begin VIRAMUNE treatment have a greater risk.
If you are a woman with CD4+ >250 cells/mm3 or a man with CD4+ >400 cells/mm3
you should not begin taking VIRAMUNE unless you and your doctor have decided that
the benefit of doing so outweighs the risk. Women, including pregnant women, with
CD4+ cell counts >250 cells/mm3 are at the greatest risk. •
The dose of VIRAMUNE for adults is one 200-mg tablet daily for the first 14 days,
followed by one 200-mg tablet twice daily. The 14-day lead-in period is important
because it can help reduce your chances of getting a potentially serious skin
rash. •
Other side effects that patients have experienced include nausea, fatigue, fever,
headache, vomiting, diarrhea, abdominal pain and myalgia. Changes in body fat
may occur in patients receiving antiretroviral therapy. Immune reconstitution
syndrome has been reported in patients treated with combination ARV therapy.
What
is known about side effects?
•
Liver problems have been reported in HIV-positive people treated with Viramune.
The greatest risk of liver problems is during the first six weeks of treatment.
Liver problems are more likely to occur in women (including pregnant women) with
T-cell counts greater than 250 at the time of starting anti-HIV treatment for
the first time. As for men, liver problems are more likely to occur if the T-cell
count is above 400 at the time of starting anti-HIV treatment for the first time.
HIV-positive people should work with their doctors very carefully if they have
T-cell counts above these levels and are planning on starting therapy for the
first time with a drug regimen that contains Viramune.
•
The most common side effect of Viramune is skin rash. In a small number of patients,
rash has been serious and resulted in death. Therefore, if you develop a rash
with any of the following symptoms, call your doctor immediately: general ill
feeling, fever, muscle or joint aches, blisters, mouth sores, conjunctivitis (inflammation
of the inner surface of the eyelids), swelling of the face, tiredness.
•
If you must stop treatment with Viramune because you have these types of serious
reactions, you must not take Viramune again.
What
about drug interactions?
•
The following medications
should not be taken while you are being treated with Viramune: Antibiotics:
Rifadin (rifampin) and Priftin (rifapentine).
•
All of the available nucleoside reverse transcriptase inhibitors can be combined
safely with Viramune.
•
Viramune can interact with some medications used to treat TB, MAC and other bacterial
infections. Rifadin (rifampin) can decrease Viramune levels (Rifadin should not
be used). Mycobutin (rifabutin) can also decrease Viramune levels (no dose change
necessary). Viramune can also decrease Biaxin (clarithromycin) levels; similarly
Biaxin can increase Viramune levels (an alternative to Biaxin is recommended).
•
Viramune can interact with some medications used to treat thrush (candidiasis)
and other fungal infections. Viramune can decrease Nizoral (ketoconazole) levels
in the bloodstream. Similarly, Nizoral can increase Viramune levels in the bloodstream.
Taking these two drugs together is not recommended.
•
Viramune can interact with oral contraceptives/birth control pills (ethinyl estradiol).
Viramune decreases the amount of ethinyl estradiol in the bloodstream, which can
increase the risk of pregnancy.
•
If you take methadone, Viramune can decrease the amount of it in your blood. This
might cause you to experience withdrawal symptoms and may require that your doctor
or your rehabilitation program increase your dose of methadone.
•
It is not yet known what effect Viramune has on blood levels of Viagra (sildenafil)
or Levitra (vardenafil), two drugs used for erectile dysfunction.
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