Labeling
Change for Nevirapine (Viramune) Tablets and Oral Solution, Including an Upgrade
to Pregnancy Category B
Viramune
Tablet
On August 15, BoehringerIngelheim announced that the U.S. Food and Drug Administration
(FDA) has approved an upgrade in the pregnancy category for the non-nucleoside
reverse transcriptase inhibitor (NNRTI) nevirapine (Viramune)
from Category C to Category B. Nevirapine is indicated
for the treatment of HIV-1 infection in combination
with other antiretroviral agents.
Category C indicates that animal studies
have shown an adverse effect on the fetus, and while there are no adequate, well-controlled
studies in humans, potential benefits may warrant use of the drug by pregnant
women despite potential risks. Category B indicates either that animal studies
have failed to demonstrate a fetal risk, or that while animal studies have shown
an adverse effect, adequate and well-controlled studies in pregnant women have
failed to demonstrate a similar risk during any trimester.
Following are excerpts from the
text of the company’s announcement:
Viramune should be used during pregnancy only
if the potential benefit justifies the potential risk to the fetus. The upgrade
in the Viramune pregnancy category is based on the lack
of observable teratogenicity in reproductive studies
performed in animal models, an evaluation of Viramune use in pregnant women in clinical trials, and an
analysis of data from the Antiretroviral Pregnancy Registry.
Animal reproduction studies are not
always predictive of human response. The safety of Viramune
in pregnant women and fetuses has not been established in adequate and well-controlled
human studies.
In their analysis, the Antiretroviral
Pregnancy Registry found no increased risk of birth defects following first trimester
exposure to Viramune using data from January 1989 to
July 2006. The prevalence of birth defects after any trimester exposure to Viramune
is comparable to the prevalence observed in the general
population.
This change makes Viramune the only pregnancy Category B NNRTI. Viramune is also the only NNRTI recommended
by the Department of Health and Human Services for use in pregnant women.
Pregnancy category is one of many treatment
considerations for discussion by HIV-positive women and their health care providers,
who need to discuss the benefits and risks of all available treatments to choose
a therapy that best addresses individual needs.
It is important to note that life-threatening
and fatal hepatotoxicity [liver toxicity] has occurred
in patients receiving Viramune. Women, including pregnant
women, with CD4 cell counts greater than 250 cells/mm3 are at the greatest risk. Viramune should not be initiated in adult females with CD4
cell counts greater than 250 cells/mm3 unless
the benefit outweighs the risk. It is unclear if pregnancy augments the risk observed
in non-pregnant women.
In addition to the change in Pregnancy
Category, other changes were made to the Precautions section and Clinical Pharmacology
section of the Viramune prescribing information that
may impact women. Please see the full Viramune prescribing information for additional information
on reports of Immune Reconstitution Syndrome, updated information on lopinavir/ritonavir (Kaletra) dosing
with Viramune, and information regarding Viramune interactions with methadone.
About Viramune
Viramune is indicated for use in combination with other antiretroviral agents for the
treatment of HIV-1 infection.
Viramune 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. Patients should ask their healthcare
provider about how to recognize these problems. Patients should stop taking Viramune
and should not restart it if they have these reactions. Patients should call their
healthcare provider immediately.
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.
Women, including pregnant women, with
CD4 cell counts greater than 250 cells/mm3
are at the greatest risk. Female patients with CD4 cell counts greater than 250
cells/mm3 or male patients with CD4 cell counts greater than 400 cells/mm3 should not begin taking Viramune unless they and their doctor have decided that the
benefit of doing so outweighs the 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 chances of getting a 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.
Sources BoehringerIngelheim.
Labeling Change for Viramune (nevirapine) tablets/oral solution including Change to Pregnancy
Category.Viramune Community Statement. August 15, 2007. www.HIVandhepatitis.com:
