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VIRAMUNE®
(VIH-rah-mune)
(nevi rapine) Tablets

VIRAMUNE®
(VIH-rah-mune)
(nevi rapine) Oral Suspension

VIRAMUNE® XR™
(VIH-rah-mune)
(nevi rapine) Extended-Release Tablets

Read this Medication Guide before you start taking VIRAMUNE and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment.

What is the most important information I should know about VIRAMUNE?

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.

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:

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

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:

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:

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.

See the section "What are the possible side effects of VIRAMUNE?" for more information.

What is VIRAMUNE?

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

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"). You must take VIRAMUNE with other anti-HIV medicines. When you take VIRAMUNE with other anti-HIV medicines, VIRAMUNE can lower your viral load and increase the number of CD4⁺ cells ("T cells"). CD4⁺ cells are a type of immune helper cell in the blood. VIRAMUNE may not have these effects in every person.

VIRAMUNE comes in 3 different forms. This Medication Guide provides information about all 3 forms of VIRAMUNE.

• VIRAMUNE tablets
• VIRAMUNE oral suspension
• VIRAMUNE XR extended release tablets

VIRAMUNE XR extended-release tablets are not for use in children.

VIRAMUNE does not cure HIV or AIDS, and it is not known if it will help you live longer with HIV. People taking VIRAMUNE may still get infections common in people with HIV (opportunistic infections). It is very important that you stay under the care of your doctor.

It is not known if VIRAMUNE lowers the chance of passing HIV to other people. Effective treatment combined with safer sex practices, may reduce the chance of passing HIV to others through sexual contact. Always practice safer sex by using a latex or polyurethane condom or other barrier method to lower the chance of sexual contact with any body fluids such as semen, vaginal secretions, or blood. Never reuse or share needles. Take your HIV medicines as prescribed.

Who should not take VIRAMUNE?

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.

What should I tell my doctor before taking VIRAMUNE?

Before you take VIRAMUNE, tell your doctor if you:

• have or have had hepatitis (inflammation of your liver) or problems with your liver. See "What is the most important information I should know about VIRAMUNE?" and "Who should not take VIRAMUNE?"
• 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. 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®)
• 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.

How should I take VIRAMUNE?

• 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.
• Do not crush or chew VIRAMUNE XR extended-release tablets.
• 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.

Starting VIRAMUNE XR extended-release tablets and this is the first time you are taking any form of VIRAMUNE:

1. Your doctor should start you with 1 dose of VIRAMUNE tablets 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 start VIRAMUNE XR extended-release tablets if you have a rash.

2. Day 15, you will take 1 VIRAMUNE XR extended-release tablet each day.

Switching from VIRAMUNE tablets to VIRAMUNE XR extended-release tablets:

1. Take VIRAMUNE XR extended-release tablet 1 time a day.

If you take VIRAMUNE Oral Suspension:

• 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.

What are the possible side effects of VIRAMUNE?

VIRAMUNE may cause serious side effects, including:

• See "What is the most important information I should know about VIRAMUNE?"
• 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 VIRAMUNE. 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.

How should I store VIRAMUNE?

• 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.

General information about VIRAMUNE.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use VIRAMUNE for a condition for which it was not prescribed. Do not give VIRAMUNE to other people, even if they have the same condition you have. It may harm them.

This Medication Guide summarizes the most important information about VIRAMUNE. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about VIRAMUNE that is written for health professionals.

For more information, go to www.viramune.com or www.viramunexr.com or call Boehringer Ingelheim Pharmaceuticals, Inc., at 1-800-542-6257, or (TTY) 1-800-459-9906.

What are the ingredients in VIRAMUNE?

Active ingredient: nevirapine Inactive ingredients:

VIRAMUNE Tablets: microcrystalline cellulose, lactose monohydrate, povidone, sodium starch glycolate, colloidal silicon dioxide, and magnesium stearate

VIRAMUNE Oral Suspension: carbomer 934P, methylparaben, propylparaben, sorbitol, sucrose, polysorbate 80, sodium hydroxide, and purified water

VIRAMUNE XR Tablets: lactose monohydrate, hypromellose, iron oxide, and magnesium stearate

This Medication Guide has been approved by the U.S. Food and Drug Administration

Last reviewed on RxList: 11/18/2011
This monograph has been modified to include the generic and brand name in many instances.