Viramune

(Nevirapine)

The active ingredient in Viramune is nevirapine. Viramune (nevirapine) works as a non-nucleoside reverse transcriptase inhibitor (NNRTI) used in HIV treatment. It binds directly to the HIV-1 reverse transcriptase enzyme, causing a structural change that blocks its activity. This prevents the virus from converting its RNA into DNA, which is an essential step for viral replication. As a result, HIV replication is reduced, and viral load decreases, especially when Viramune is used in combination with other antiretroviral medicines.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Viramune. However, the following is a synopsis of the general guidelines for the use of Viramune:

• Viramune is taken by mouth as a tablet or oral suspension.
• Treatment begins with a lead-in period of once-daily dosing to reduce the risk of skin reactions.
• After the lead-in phase, dosing usually increases to twice daily or once daily for extended-release tablets.
• Viramune must be taken as part of combination antiretroviral therapy.
• Do not stop or skip doses, as this may increase viral resistance.
• Missed doses should be taken as soon as remembered, unless it is close to the next dose.

Some mild or common side effects of Viramune seen in clinical trials as compared to placebo include:

• Skin rash.
• Fatigue.
• Loss of appetite.
• Muscle pain or joint pain.
• Changes in body fat.

Some individuals may experience serious side effects while using Viramune. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Severe skin reactions, including Stevens-Johnson syndrome or toxic epidermal necrolysis. Symptoms include blistering skin or a severe rash with fever.
• Life-threatening allergic reactions.
• Liver problems, including hepatitis and liver failure.

These are not all of the possible adverse events with Viramune. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Viramune, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Liver disease or hepatitis B or C.
• A history of severe skin reactions.
• High CD4+ cell counts at treatment initiation.
• Pregnancy or plans to become pregnant.
• A history of hypersensitivity reactions.
• Liver function tests and blood tests are needed during the first 18 weeks of treatment and periodically thereafter.

Boxed Warning

Viramune has a boxed warning for life-threatening liver toxicity and severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis.

Viramune should not be used in patients who:

• Have experienced severe hypersensitivity reactions to nevirapine.
• Have severe liver impairment.
• Are using it as part of a postexposure prophylaxis (PEP) regimen.

Viramune begins working immediately after initiation, but reductions in viral load are typically seen over several weeks of therapy when taken consistently with other antiretrovirals.

When Viramune is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• St. John’s wort, which can reduce nevirapine levels.
• Ketoconazole or itraconazole may have reduced effectiveness.
• Clarithromycin may have altered blood levels.
• Rifabutin may require dose adjustments.
• Methadone may require monitoring for withdrawal symptoms.
• Hormonal contraceptives may be less effective.
• Fluconazole.
• Lopinavir.
• Zidovudine.

Viramune is available as:

Immediate-release tablets.

Extended-release tablets.

Oral suspension for pediatric and adolescent patients.

It should be stored at room temperature, away from the reach of children or pets.

Viramune is manufactured by Boehringer Ingelheim.

Yes. Generic nevirapine is available.

Do not stop taking Viramune without medical advice. Your healthcare provider will guide any treatment changes to avoid viral resistance.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you based on your viral load and CD4+ cell counts.

HIV-infected women are generally advised not to breastfeed due to the risk of virus transmission through breast milk. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed.