MEDICATION GUIDE
NEVIRAPINE TABLETS, USP
(ne vir′ a peen)
200 mg

Read this Medication Guide before you start taking nevirapine tablets 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 nevirapine tablets?

Nevirapine tablets 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 nevirapine tablets 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 nevirapine 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 nevirapine tablets 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 nevirapine 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 nevirapine tablets 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
   • nausea (feeling sick to your stomach)
   • feel unwell or like you have the flu
   • 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 nevirapine tablets. You should continue to have your liver checked regularly during your treatment with nevirapine tablets. 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 nevirapine tablets. Most rashes happen in the first 6 weeks of taking nevirapine tablets. Rashes and skin reactions may be severe, life threatening and in some people, may lead to death. Stop using nevirapine tablets 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
   • fever
   • feel unwell or like you have the flu
   • tiredness
   • muscle or joint aches

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

See the section “What are the possible side effects of nevirapine tablets?” for more information.

What is nevirapine?

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

Nevirapine is a type of anti-HIV medicine called a “non-nucleoside reverse transcriptase inhibitor” (NNRTI). Nevirapine works by lowering the amount of HIV in your blood (“viral load”). You must take nevirapine tablets with other anti-HIV medicines. When you take nevirapine with other anti-HIV medicines, nevirapine 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. Nevirapine may not have these effects in every person.

Nevirapine comes in three different forms. This Medication Guide provides information about nevirapine tablets.

• Nevirapine tablets
• Nevirapine oral suspension
• Nevirapine extended release tablets

Nevirapine extended-release tablets are not for use in children.

Nevirapine tablets do not cure HIV or AIDS and it is not known if it will help you live longer with HIV. People taking nevirapine tablets 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 nevirapine tablets lower 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 re-use or share needles. Take your HIV medicines as prescribed.

Who should not take nevirapine tablets?

Tell your doctor if you have or have had liver problems. Your doctor may tell you not to take nevirapine tablets if you have certain liver problems.

Nevirapine tablets are only for people diagnosed with HIV. If you have not been diagnosed as HIV positive, then do not take nevirapine tablets.

What should I tell my doctor before taking nevirapine tablets?

Before you take nevirapine tablets, 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 nevirapine tablets?” and “Who should not take nevirapine tablets?”
• receive dialysis
• have skin problems, such as a rash
• are pregnant or plan to become pregnant. It is not known if nevirapine 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. Nevirapine 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 nevirapine tablets. 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. Nevirapine tablets may affect the way other medicines work and other medicines may affect how nevirapine tablets work.

You should not take nevirapine tablets if you also take:

• St. John’s Wort. St. John’s Wort can lower the amount of nevirapine 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 nevirapine tablets.

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 nevirapine tablets?

• Nevirapine tablets are always taken in combination with other anti-HIV medications.
• Take nevirapine tablets 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 nevirapine at the same time. Talk to your doctor if you have any questions.
• You may take nevirapine tablets with or without food.
• Do not miss a dose of nevirapine tablets, because this could make HIV harder to treat. If you miss a dose of nevirapine tablets, 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 nevirapine tablets 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 nevirapine tablets starting dose again, which is taken one time each day for 14 days.

  Starting nevirapine tablets:

  • Your doctor should start you with one dose each day to lower your chance of getting a serious rash. It is important that you only take one dose of nevirapine tablets each day for the first 14 days.
    • Call your doctor right away if you get a skin rash during the first 14 days of nevirapine 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 nevirapine tablets.
    • Do not increase your dose to 2 times a day if you have a rash.
  • Day 15, you will take one nevirapine tablet 2 times a day.

 Switching from nevirapine tablets to nevirapine extended-release tablets:

1. Take nevirapine extended-release tablets one time a day.

What are the possible side effects of nevirapine tablets?

Nevirapine tablets may cause serious side effects, including:

• See “What is the most important information I should know about nevirapine tablets?”
  • 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 nevirapine tablets 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 tablets. 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 nevirapine tablets?

• Store nevirapine tablets at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]
• Throw away nevirapine tablets that are no longer needed or out-of-date.

Keep nevirapine tablets and all medicines out of the reach of children.

General information about nevirapine tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use nevirapine tablets for a condition for which it was not prescribed. Do not give nevirapine tablets 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 nevirapine tablets. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about nevirapine tablets that is written for health professionals.

For more information, call Mylan Pharmaceuticals Inc. at 1-877-4-INFO-RX (1-877-446-3679).

What are the ingredients in nevirapine tablets?

Active Ingredient: nevirapine, USP

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

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

** The brand names mentioned are registered trademarks of their respective manufacturers.

Manufactured in India by:
Mylan Laboratories Limited
Hyderabad—500 034, India
Code No.: MH/DRUGS/25/NKD/89

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

This Product was Repackaged By:

State of Florida DOH Central Pharmacy
104-2 Hamilton Park Drive
Tallahassee, FL 32304
United States