Viramune Oral Solution

The active ingredient in Viramune is nevirapine. Nevirapine belongs to a drug class called non-nucleoside reverse transcriptase inhibitors (NNRTIs), and its mechanism of action involves blocking reverse transcriptase, an enzyme that HIV needs to copy itself. By slowing HIV replication, Viramune lowers viral load and helps protect CD4+ cell counts, which are an important measure of immune strength.

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 must be taken with other HIV medicines. Do not use it alone.
• Treatment usually starts with a once-daily lead-in dose for the first 14 days. This lowers the risk of life-threatening skin reactions.
• After the lead-in period, the dose is typically increased to a full daily dose, such as 200 mg twice daily for immediate-release tablets, or once daily for extended-release tablets, depending on your prescription.
• The oral suspension should be shaken well before each dose and measured carefully using an approved dosing device.
• Take Viramune at the same time each day.
• If you miss a dose during the lead-in period, contact your healthcare provider. You may need to restart the lead-in schedule.
• Do not stop Viramune without medical advice. Stopping suddenly can raise viral load and lead to drug resistance.
• Your healthcare provider will order blood tests at baseline and during the first weeks of treatment to monitor liver function.

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

• Skin rash, usually mild.
• Nausea.
• Headache.
• Fatigue or tiredness.
• Fever.
• Diarrhea.
• Abdominal pain.
• Loss of appetite.
• Dizziness or sleepiness.
• Muscle aches.

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 rash with blisters, peeling, sores, or body surface area involvement, which may be Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Rash with fever, swollen glands, facial swelling, muscle aches, or breathing trouble, which may be a hypersensitivity reaction.
• Liver problems such as jaundice, dark urine, pale stools, nausea that doesn’t go away, severe tiredness, abdominal pain on the right side, or loss of appetite.
• Signs of hepatitis or hepatotoxicity on blood tests.
• Severe allergic reactions such as hives, swelling of the face or throat, or trouble breathing.
• Worsening HIV symptoms after starting therapy, which may reflect immune system changes.

These are not all of the possible side effects of 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:

• Liver problems, hepatitis B, or hepatitis C.
• A history of jaundice or abnormal liver function tests.
• A previous serious skin reaction to any medicine.
• A history of allergic reactions or hypersensitivity.
• High CD4+ cell counts at baseline, because this can increase hepatitis risk with nevirapine.
• Use of hormonal contraception.
• Use of supplements, St. John’s wort, or over-the-counter products.
• Any past trouble with antiretroviral agents.
• The highest risk for severe rash or hepatotoxicity occurs in the first 6 to 18 weeks. Contact your healthcare provider immediately if you notice rash, fever, blistering, or signs of liver injury. Never restart Viramune after a severe rash or liver reaction unless your healthcare provider specifically directs you to.

Boxed Warning

Viramune has a boxed warning for severe, life-threatening, and sometimes fatal liver toxicity and skin reactions. These reactions are most likely to happen during the first 18 weeks of treatment, especially in the first 6 weeks. Risk is higher in people with higher CD4+ cell counts and in those with hepatitis or other liver disease. Any rash, jaundice, or symptoms of hepatitis should be treated as urgent

Viramune should not be used in individuals who:

• Have had a severe skin reaction, including Stevens-Johnson syndrome or toxic epidermal necrolysis, due to nevirapine.
• Have had nevirapine-related hepatitis or serious hepatotoxicity in the past.
• Are allergic to nevirapine or any inactive ingredient in the tablet or oral suspension.

Viramune begins working after the first dose by lowering HIV activity. Viral load usually starts to fall within a few weeks, but it can take several months to reach the full effect. Improvements in CD4+ cell count may take longer. Your healthcare provider will monitor your virologic response with regular blood tests. Staying consistent with daily doses is essential to prevent resistance and keep the medicine effective.

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.
• Rifabutin.
• Ketoconazole or itraconazole.
• Fluconazole.
• Clarithromycin.
• Methadone.
• Lopinavir or ritonavir.
• Atazanavir.
• Efavirenz. Combining NNRTIs can increase side effects and is generally avoided unless directed by an HIV specialist.
• Zidovudine or lamivudine.
• Hormonal birth control. Viramune can lower hormone levels and reduce contraceptive effectiveness.

Viramune is available in the following dosage forms:

Immediate-release tablets, commonly 200 mg.

Extended-release tablets (Viramune XR), commonly 400 mg.

Oral suspension for pediatric use or adults who cannot swallow tablets.

Dosing depends on age, weight, and treatment phase. A lead-in schedule is standard unless your healthcare provider advises otherwise.

Store at room temperature and keep out of reach of children.

Viramune is manufactured by Boehringer Ingelheim.

Yes. Generic nevirapine is available in many regions in both immediate-release and extended-release forms, as well as oral suspension.

Do not stop taking Viramune without speaking to your healthcare provider. Stopping can cause viral load to rebound and may lead to resistance. If you develop a severe rash or signs of liver injury, stop the medicine and seek urgent medical care. Your healthcare provider will decide whether Viramune can be safely restarted or whether another HIV medicine should be used.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. Viramune has been used in pregnant women, including for the prevention of mother-to-child transmission, but it carries liver and rash risks. Your healthcare provider will weigh the benefits and risks and may recommend enrollment in a pregnancy registry.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. In most settings, women with HIV are advised not to breastfeed because HIV can pass through breast milk, even if the viral load is low. Your healthcare provider will guide you based on your situation and local medical standards.