Viramune

Viramune is a prescription medication used in combination with other medicines to treat human immunodeficiency virus (HIV) infection. Viramune is a type of anti-HIV medicine called a "non-nucleoside reverse transcriptase inhibitor" (NNRTI). Viramune works by lowering the amount of HIV in your blood ("viral load").

This medication comes in tablet and suspension form. It is taken once daily for 14 days, and if no rash develops you will take it twice daily thereafter.

The most common Viramune side effect is rash.

Viramune is a prescription medicine used to treat Human Immunodeficiency Virus (HIV), the virus that causes AIDS (Acquired Immune Deficiency Syndrome).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Boehringer Ingelheim Pharmaceuticals, Inc.

Viramune may cause serious side effects, including:

• See "Viramune Precautions".
• Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your doctor if you start having new symptoms after starting your HIV medicine.
• Changes in body fat can happen in some people who take antiretroviral therapy. These changes may include increased amount of fat in the upper back and neck ("buffalo hump"), breast, and around the middle of your body (trunk). Loss of fat from your legs, arms, and face can also happen. The cause and long-term health effects of these problems are not known at this time.

The most common side effect of Viramune is rash. 

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of nevirapine. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor and pharmacist about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Viramune may affect the way other medicines work, and other medicines may affect how Viramune works.

You should not take Viramune if you also take:

• St. John's Wort.  St. John's Wort can lower the amount of Viramune in your body.
• efavirenz (Sustiva, Atripla). Efavirenz may cause you to have an increased chance of side effects.
• atazanavir (Reyataz)
• boceprevir (Victrelis)
• telaprevir (Incivek)
• lopinavir and ritonavir (Kaletra)
• fosamprenavir calcium (Lexiva)
• itraconazole (Sporanox)
• ketoconazole (Nizoral)
• rifampin (Rifadin, Rifamate, Rifater)
• Birth control pills. Birth control pills taken by mouth (oral contraceptives) and other hormone types of birth control may not work to prevent pregnancy. Talk with your doctor about other types of birth control that you can use to prevent pregnancy during treatment with Viramune.

Also tell your doctor if you take:

• clarithromycin (Biaxin)
• fluconazole (Diflucan)
• indinavir sulfate (Crixivan)
• methadone
• nelfinavir mesylate (Viracept)
• rifabutin (Mycobutin)
• warfarin (Coumadin, Jantoven)
• saquinavir mesylate (Invirase)

If you are not sure if you take a medicine above, ask your doctor or pharmacist. Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine.

Viramune can cause serious side effects. These include severe liver and skin problems that can cause death. These problems can happen at any time during treatment, but your risk is highest during the first 18 weeks of treatment.

• Women with CD4+ counts higher than 250 cells/mm3. This group has the highest risk.
• Men with CD4+ counts higher than 400 cells/mm3.

1.  Severe liver problems: Anyone who takes Viramune may get severe liver problems. In some cases these liver problems can lead to liver failure and the need for a liver transplant, or death. People who have a higher CD4+ cell count when they begin Viramune treatment have a higher risk of liver problems, especially:

If you are a woman with CD4+ counts higher than 250 cells/mm3 or a man with CD4+ counts higher than 400 cells/mm3, you and your doctor will decide whether starting Viramune is right for you.

In general, women have a higher risk of liver problems compared to men.

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.

You may get a rash if you have liver problems.

Stop taking Viramune and call your doctor right away if you have any of the following symptoms of liver problems:

• dark (tea colored) urine
• yellowing of your skin or whites of your eyes
• light-colored bowel movements (stools)
• fever
• feel unwell or like you have the flu
• nausea (feeling sick to your stomach)
• pain or tenderness on your right side below your ribs
• tiredness
• loss of appetite

Your doctor should see you and do blood tests often to check your liver function during the first 18 weeks of treatment with Viramune. You should continue to have your liver checked regularly during your treatment with Viramune. It is important for you to keep all of your doctor appointments.

2.  Severe rash and skin reactions: Skin rash is the most common side effect of Viramune. Most rashes happen in the first 6 weeks of taking Viramune. Rashes and skin reactions may be severe, life-threatening, and in some people, may lead to death. Stop using Viramune and call your doctor right away if you get a rash with any of the following symptoms:

• blisters
• mouth sores
• red or inflamed eyes, like "pink eye" (conjunctivitis)
• liver problems (see symptoms of liver problems above)
• swelling of your face
• feel unwell or like you have the flu
• fever
• tiredness
• muscle or joint aches

If your doctor tells you to stop treatment with Viramune because you have had any of the serious liver or skin problems described above, you should never take Viramune again.

Tell your doctor if you have or have had liver problems. Your doctor may tell you not to take Viramune if you have certain liver problems. Viramune is only for people diagnosed with HIV. If you have not been diagnosed as HIV positive, then do not take Viramune.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Viramune there are no specific foods that you must exclude from your diet.

Before you take Viramune, tell your doctor if you:

• have or have had hepatitis (inflammation of your liver) or problems with your liver. 
• receive dialysis
• have skin problems, such as a rash
• are pregnant or plan to become pregnant. It is not known if Viramune will harm your unborn baby.
  Pregnancy Registry: There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of the registry is to collect information about the health of you and your baby. Talk to your doctor about how you can take part in this registry.
• are breast-feeding or plan to breast-feed. Viramune can pass into your breast milk and may harm your baby. It is also recommended that HIV-positive women should not breast-feed their babies. Do not breast-feed during treatment with Viramune. Talk to your doctor about the best way to feed your baby.

Tell your doctor and pharmacist about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. 

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category B.  It is not known if Viramune will harm your unborn baby.

Pregnancy Registry: There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of the registry is to collect information about the health of you and your baby. Talk to your doctor about how you can take part in this registry.

Tell your doctor if you are breastfeeding or plan to breastfeed. Viramune can pass into your breast milk and may harm your baby. It is also recommended that HIV-positive women should not breastfeed their babies. Do not breast-feed during treatment with Viramune. Talk to your doctor about the best way to feed your baby.

Viramune is always taken in combination with other anti-HIV medications.

• Take Viramune exactly as your doctor tells you to take it. Do not change your dose unless your doctor tells you to.
• You should never take more than one form of Viramune at the same time. Talk to your doctor if you have any questions.
• You may take Viramune with or without food.
• Do not miss a dose of Viramune, because this could make HIV harder to treat. If you miss a dose of Viramune, take the missed dose as soon as you remember. If it is almost time for your next dose, do not take the missed dose, just take the next dose at your regular time. Do not take two doses at the same time.
• If you stop taking Viramune for more than 7 days, ask your doctor how much to take before you start taking it again. You may need to begin taking the Viramune starting dose again, which is taken 1 time each day for 14 days.

Starting Viramune tablets:

1. Your doctor should start you with 1 dose each day to lower your chance of getting a serious rash. It is important that you only take 1 dose of Viramune each day for the first 14 days.
   • Call your doctor right away if you get a skin rash during the first 14 days of Viramune treatment and do not increase your dose to 2 times a day.
   • You should never take your starting dose for longer than 28 days. If after 28 days you are still receiving this starting dose because you have a rash, you and your doctor should talk about prescribing another HIV medicine for you instead of Viramune.
   • Do not increase your dose to 2 times a day if you have a rash.
      
2. Day 15, you will take 1 Viramune tablet two times a day.

If you or your child takes Viramune suspension (liquid), shake it gently before each use. Use an oral dosing syringe or dosing cup to measure the right dose. The oral dosing syringe and dosing cup are not provided with Viramune suspension. Ask your pharmacist for a syringe or cup if you do not have one.

• After drinking the medicine, fill the dosing cup with water and drink it to make sure you get all the medicine.
• If the dose is less than 1 teaspoon (5 mL), use the syringe instead of the dosing cup.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dose for Viramune (nevirapine) is one 200 mg tablet daily for the first 14 days, followed by one 200 mg tablet twice daily, in combination with other antiretroviral agents.

You must never take more than one form of Viramune at the same time.

The recommended oral dose for children 15 days of age and older is 150 mg/m2 once daily for 14 days followed by 150 mg/m2 twice daily thereafter. The total daily dose should not exceed 400 mg for any patient. 

If you take too much Viramune, call your local Poison Control Center or seek emergency medical attention right away.

• Store Viramune at 59°F to 86°F (15°C to 30°C).
• Throw away Viramune that is no longer needed or out-of-date.
• Keep Viramune and all medicines out of the reach of children.

WARNING: LIFE-THREATENING (INCLUDING FATAL) HEPATOTOXICITY and SKIN REACTIONS

HEPATOTOXICITY:

Severe, life-threatening, and in some cases fatal hepatotoxicity, particularly in the first 18 weeks, has been reported in patients treated with nevirapine. In some cases, patients presented with non-specific prodromal signs or symptoms of hepatitis and progressed to hepatic failure. These events are often associated with rash. Female gender and higher CD4+ cell counts at initiation of therapy place patients at increased risk; women with CD4+ cell counts greater than 250 cells/mm3, including pregnant women receiving Viramune in combination with other antiretrovirals for the treatment of HIV-1 infection, are at the greatest risk. However, hepatotoxicity associated with Viramune use can occur in both genders, all CD4+ cell counts and at any time during treatment. Hepatic failure has also been reported in patients without HIV taking Viramune for post-exposure prophylaxis (PEP). Use of Viramune for occupational and non-occupational PEP is contraindicated. Patients with signs or symptoms of hepatitis, or with increased transaminases combined with rash or other systemic symptoms, must discontinue Viramune and seek medical evaluation immediately.

SKIN REACTIONS:

Severe, life-threatening skin reactions, including fatal cases, have occurred in patients treated with Viramune. These have included cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity reactions characterized by rash, constitutional findings, and organ dysfunction. Patients developing signs or symptoms of severe skin reactions or hypersensitivity reactions must discontinue Viramune and seek medical evaluation immediately. Transaminase levels should be checked immediately for all patients who develop a rash in the first 18 weeks of treatment. The 14-day lead-in period with Viramune 200 mg daily dosing has been observed to decrease the incidence of rash and must be followed.

MONITORING:

Patients must be monitored intensively during the first 18 weeks of therapy with Viramune to detect potentially life-threatening hepatotoxicity or skin reactions. Extra vigilance is warranted during the first 6 weeks of therapy, which is the period of greatest risk of these events. Do not restart Viramune following clinical hepatitis, or transaminase elevations combined with rash or other systemic symptoms, or following severe skin rash or hypersensitivity reactions. In some cases, hepatic injury has progressed despite discontinuation of treatment.