Important Safety Information

Patients taking Viramune^® (nevirapine) may develop severe liver disease or skin reactions that can cause death. The risk of these reactions is greatest during the first 18 weeks of treatment, but these reactions also can occur later.

Liver Reactions
Any patient can experience liver problems while taking VIRAMUNE. However, women and patients who have higher CD4 counts when they begin VIRAMUNE treatment have a greater chance of developing liver damage. Women with CD4 counts higher than 250 cells/mm³ are at the greatest risk of these events. 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. Liver problems are often accompanied by a rash.

Patients starting VIRAMUNE with abnormal liver function tests and patients with hepatitis B or C have a greater chance of developing further increases in liver function tests after starting VIRAMUNE and throughout therapy.

In rare cases liver problems have led to liver failure and can lead to a liver transplant or death. Therefore, if you develop any of the following symptoms of liver problems stop taking VIRAMUNE and call your doctor right away:

• General ill feeling or "flu-like" symptoms
• Tiredness
• Nausea (feeling sick to your stomach)
• Lack of appetite
• Yellowing of your skin or whites of your eyes
• Dark urine (tea colored)
• Pale stools (bowel movements)
• Pain, ache, or sensitivity to touch on your right side below your ribs

Your doctor should check you and do blood tests often to check your liver function during the first 18 weeks of therapy. Checks for liver problems should continue regularly during treatment with VIRAMUNE.

Skin Reactions
Skin rash is the most common side effect of VIRAMUNE. Most rashes occur in the first 6 weeks of treatment. In a small number of patients, rash can be serious and result in death. Therefore, if you develop a rash with any of the following symptoms stop using VIRAMUNE and call your doctor right away:

• General ill feeling or "flu-like" symptoms
• Fever
• Muscle or joint aches
• Conjunctivitis (red or inflamed eyes, like "pink eye")
• Any of the symptoms of liver problems discussed above
• Blisters
• Mouth sores
• Swelling of your face
• Tiredness

If your doctor tells you to stop treatment with VIRAMUNE because you have experienced the serious liver or skin reactions described above, never take VIRAMUNE again.

These are not all the side effects of VIRAMUNE. (See the section "What are the possible side effects of VIRAMUNE?" in the Medication Guide for more information.) Tell your doctor if you have any side effects from VIRAMUNE.