Glossary
Adherence (ad-héer-əns): Consistently taking medication as prescribed. If a patient does not adhere to HIV medication as prescribed, it is possible to develop drug resistance.
AIDS: Stands for Acquired Immune Deficiency Syndrome.
AIDS-defining infection or condition: Also known as opportunistic (op”ər-too-nis′tik) infection or conditions. These are usually illnesses that a person not infected with HIV normally wouldn't get.
CD4+ cells: Also known as T cells, CD4+ cells are part of your immune system. They identify and fight infections and other diseases that invade your body.
Genotypic (jen”o-ti'pik) test: A test to see if the HIV virus has developed mutations that may be resistant to certain medications.
HAART: Stands for Highly Active Anti-Retroviral Therapy. Three or four anti-HIV drugs with different methods of working are taken together to avoid resistance.
HCP: An HCP, or healthcare provider, is the doctor, nurse, pharmacist, or other healthcare professional that is responsible for your HIV care.
HIV: Human Immunodeficiency Virus. HIV infects healthy immune cells and prevents them from protecting the body from infection and disease.
Immune system (ĭ-mūn' sis'təm): Defends your body from infection and disease. HIV and AIDS can harm the functioning of your immune system.
Phenotypic (fe”no-tip'ik) test: A test to see if a drug is effective against your virus by measuring the amount of a specific drug needed to keep the HIV virus from reproducing.
Regimen (rej' ĭ-mən): When used in the context of treatment, a regimen is a combination of medications taken together. It can also be called a “cocktail.”
Replicate (rep”lĭ-kāt): When used in the context of HIV, replicate is the word used to describe the action that HIV cells undergo when they make new copies of themselves.
Resistance (ri-zis'-tən[t]s): This means that some HIV medications may not work as well, or sometimes at all, against your virus.
Undetectable (un'-de-tek'table): When the HIV virus can't be found by tests used to measure the amount of it in the blood (remember, even though it can't be found, the virus is always in the body).
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.
