What is Viramune® (nevirapine) tablets/oral suspension?
VIRAMUNE is a medicine used to treat Human Immunodeficiency Virus (HIV), the virus that causes AIDS (Acquired Immune Deficiency Syndrome).
VIRAMUNE is a type of anti-HIV medicine called a "non-nucleoside reverse transcriptase inhibitor" (NNRTI). It works by lowering the amount of HIV in the blood ("viral load"). You must take VIRAMUNE with other anti-HIV medicines. When taken with other anti-HIV medicines, VIRAMUNE can reduce viral load and increase the number of CD4 cells ("T cells"). CD4 cells are a type of immune helper cell in the blood. VIRAMUNE may not have these effects in every patient.
VIRAMUNE does not cure HIV or AIDS, and it is not known if it will help you live longer with HIV. People taking VIRAMUNE may still get infections common in people with HIV (opportunistic infections). Therefore, it is very important that you stay under the care of your doctor.
VIRAMUNE in combination therapy treats HIV.
- VIRAMUNE helps decrease viral load to undetectable levels
- VIRAMUNE can increase CD4+ cell counts, which may improve your immune system
Only your doctor can tell you if VIRAMUNE is right for you.
INDICATION AND IMPORTANT SAFETY INFORMATION
VIRAMUNE is indicated for use in combination with other antiretroviral agents for the treatment of HIV 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. 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.
VIRAMUNE is only for people diagnosed with HIV. If you have not been diagnosed as HIV positive, then do not take VIRAMUNE.
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.
Do not take VIRAMUNE if you have severe liver problems.
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. VIRAMUNE is always taken with other anti-HIV medications. The 14-day lead-in period is important because it can help reduce your chances of getting a potentially serious skin rash. If you have a skin rash during the first 14 days, immediately contact your doctor and do not increase your VIRAMUNE dose to twice a day. The total duration of the once daily lead-in dosing period should not exceed 28 days, at which point an alternative regimen may need to be started.
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.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or
Please see full Prescribing Information, including boxed WARNING and Medication Guide, for VIRAMUNE.
