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Labeling Change for Viramune (nevirapine) tablets/oral solution including Change to Pregnancy Category B
 
 
  August 15, 2007
 
Boehringer Ingelheim announces that the U.S. Food and Drug Administration (FDA) recently approved the upgrade in pregnancy category for Viramune (nevirapine) tablets from Category C to Category B. VIRAMUNE, a non-nucleoside reverse transcriptase inhibitor (NNRTI), is indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents.
 
It is important to note that life-threatening and fatal hepatotoxicity 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 nonpregnant women. 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.
 
In addition to the change in Pregnancy Category, other changes were made to the Precautions section and Clinical Pharmacology section of the VIRAMUNE PI that may impact women. Please see the full VIRAMUNE prescribing information for additional information on reports of Immune Reconstitution Syndrome, updated information on 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.
 
Full prescribing information is attached and can be found at www.VIRAMUNE.com.
 
 
 
 
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