Viramune XR

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

This medication comes in an extended-release tablet form. It is taken typically once daily. Before starting Viramune XR, your doctor will have you start on Viramune regular release tablets and/or suspension for 14 days to lower your risk of getting a serious rash.

The most common Viramune XR side effect is rash.

Viramune XR 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 XR may cause serious side effects, including:

• See "Viramune XR 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 XR 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 XR may affect the way other medicines work, and other medicines may affect how Viramune XR works.

You should not take Viramune XR if you also take:

• St. John's Wort.  St. John's Wort can lower the amount of Viramune XR 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 XR.

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 XR 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 XR 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 XR 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 XR 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 XR 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 XR 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 XR. You should continue to have your liver checked regularly during your treatment with Viramune XR. 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 XR. Most rashes happen in the first 6 weeks of taking Viramune XR. Rashes and skin reactions may be severe, life-threatening, and in some people, may lead to death. Stop using Viramune XR 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 XR because you have had any of the serious liver or skin problems described above, you should never take Viramune XR again.

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

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 XR there are no specific foods that you must exclude from your diet.

Before you take Viramune XR, 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 XR 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 XR 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 XR. 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 XR 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 XR 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 XR. Talk to your doctor about the best way to feed your baby.

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

• Take Viramune XR 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.
• Do not crush or chew Viramune XR tablets.
• You may take Viramune XR with or without food.
• Do not miss a dose of Viramune XR, because this could make HIV harder to treat. If you miss a dose of Viramune XR, 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 XR 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 XR starting dose again, which is taken 1 time each day for 14 days.

1. Starting Viramune XR tablets extended-release tablets) and this is the first time you are taking any form of Viramune:

• 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.
• Day 15, you will take 1 Viramune XR tablet once daily. 

​2. Switching from Viramune immediate release tablets to Viramune XR (extended-release tablets):

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

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 Viramune XR (nevirapine extended release tablets) (400 mg once daily). 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 XR, call your local Poison Control Center or seek emergency medical attention right away.

• Store Viramune XR at 59°F to 86°F (15°C to 30°C).
• Throw away Viramune XR that is no longer needed or out-of-date.
• Keep Viramune XR 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 Viramune XR. 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 XR in combination with other antiretrovirals for the treatment of HIV-1 infection, are at the greatest risk. However, hepatotoxicity associated with Viramune XR 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 XR for post-exposure prophylaxis (PEP). Use of Viramune XR 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 XR and seek medical evaluation immediately.

SKIN REACTIONS:

Severe, life-threatening skin reactions, including fatal cases, have occurred in patients treated with Viramune XR. 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 XR 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 XR 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 XR 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 XR 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.