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What is Viramune?
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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.
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Viramune, manufactured by Boehringer-Ingelheim,
was approved by the U.S. Food and Drug Administration
for the treatment of HIV in 1996.
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Viramune must be used in combination with other
drugs to treat HIV. It is usually combined with
two nucleoside analogues.
Important Safety Information
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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.
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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.
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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.
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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.
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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?
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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.
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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.
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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?
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The
following medications should not be taken while
you are being treated with Viramune:
Antibiotics:
Rifadin (rifampin) and Priftin (rifapentine).
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All of the available nucleoside reverse transcriptase
inhibitors can be combined safely with Viramune.
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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).
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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.
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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.
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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.
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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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