INDICATION

VIRAMUNE is a prescription medication indicated for use in combination with other antiretroviral (ARV) agents for the treatment of HIV infection.

VIRAMUNE XR is a prescription medication indicated for use in combination with other ARVs for the treatment of HIV infection in adults.

IMPORTANT SAFETY INFORMATION

VIRAMUNE and VIRAMUNE XR can cause severe and life-threatening liver and skin reactions that can, in some cases, cause death. These problems can happen at any time but occur most often during the first 18 weeks of treatment, but can occur later. People who have abnormal liver test results before starting VIRAMUNE treatment and people with hepatitis B or C also have a greater chance of getting liver problems. Your healthcare provider (HCP) will closely monitor you and test the function of your liver during the first 18 weeks of therapy. Ask your healthcare provider how to recognize symptoms of liver and skin problems. Do not take VIRAMUNE unless you have been diagnosed with HIV.

You must stop taking VIRAMUNE or VIRAMUNE XR and call your HCP immediately if you have signs or symptoms of liver or skin problems. If you stop treatment with VIRAMUNE because you had any serious liver or skin reactions, you must never take VIRAMUNE again. For some patients, damage to the liver can continue to occur after VIRAMUNE is stopped.

Any patient can experience liver problems with VIRAMUNE or VIRAMUNE XR, but women and patients who have higher CD4+ counts when they begin nevirapine treatment have a greater risk. If you are a woman with CD4+ greater than 250 cells/mm³, or a man with CD4+ greater than 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 greater than 250 cells/mm³ are at the greatest risk of severe liver problems.

Do not take VIRAMUNE or VIRAMUNE XR unless you have been diagnosed with HIV. Do not take VIRAMUNE or VIRAMUNE XR if your HCP has told you that you have moderate to severe liver disease.

VIRAMUNE and VIRAMUNE XR can cause serious side effects, including changes to your immune system (Immune Reconstitution Syndrome) and changes in body fat. The most common side effect of VIRAMUNE is rash. These are not all the possible side effects of VIRAMUNE. For more information, ask your HCP.

You should not take St. John's wort or efavirenz if you take VIRAMUNE or VIRAMUNE XR. Talk to your HCP about the additional drug to drug interactions associated with VIRAMUNE and VIRAMUNE XR.

VIRAMUNE and VIRAMUNE XR do not cure HIV or AIDS, and have not been shown to reduce the risk of passing HIV to others through sexual contact or blood contamination.

Patients new to nevirapine must start treatment with a lead-in dose of one 200 mg tablet of immediate-release VIRAMUNE once daily for the first 14 days of treatment. The 14-day lead-in period is important because it has been shown to reduce your chances of getting a potentially serious skin rash. If you experience a rash during the first 14 days, immediately contact your HCP and do not increase your dose to VIRAMUNE 200 mg twice daily or start VIRAMUNE XR 400 mg once daily until the rash has resolved. If your rash persists longer than 28 days, stop taking VIRAMUNE and call your HCP for an alternative regimen. If you stop taking VIRAMUNE or VIRAMUNE XR for longer than seven days, talk to your HCP because you will need to restart the 14-day lead-in dose.

Adult patients already on a regimen of VIRAMUNE 200 mg twice daily can be switched to VIRAMUNE XR 400 mg once daily without the 14-day lead-in period of VIRAMUNE.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please consult full Prescribing Information, including boxed WARNING and Medication Guide, which
includes dosing information and additional important risk information for VlRAMUNE XR.