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

Nevirapine 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 higher during the first 18 weeks of treatment.
1. Severe liver problems: Anyone who takes nevirapine 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 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 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. You should continue to have your liver checked regularly during your treatment with nevirapine. 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. Most rashes happen in the first 6 weeks of taking nevirapine. Rashes and skin reactions may be severe, life-threatening, and in some people, may lead to death. Stop using nevirapine 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 nevirapine because you have had any of the serious liver or skin problems described above, you should never take nevirapine again.

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

What is nevirapine?

•Nevirapine tablets are prescription HIV medicines used with other HIV medicines to treat HIV (Human Immunodeficiency Virus). HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).
•Nevirapine tablets are a type of HIV medicine called a non-nucleoside reverse transcriptase inhibitor (NNRTI).
When used with other HIV medicines, nevirapine may:
1. Reduce the amount of HIV in your blood (called "viral load")
2. Help increase the number of CD4 (T) cells in your blood which help fight off other infections.
Reducing the amount of HIV and increasing the CD4 (T) cell count may improve your immune system. This may reduce your risk of death or infections that can happen when your immune system is weak (opportunistic infections).
Nevirapine does not cure HIV infection or AIDS.
Nevirapine does not cure HIV or AIDS and you may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. You should remain under the care of a doctor when using Nevirapine.
•You must stay on continuous HIV therapy to control HIV infection and decrease HIV-related illnesses.
Avoid doing things that can spread HIV-1 infection to others:
•Do not share needles or other injection equipment.
•Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
•Do not have any kind of sex without protection. Always practice safe sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.
Ask your doctor if you have any questions on how to prevent passing HIV to other people.

Who should not take nevirapine?

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

What should I tell my doctor before taking nevirapine?

Before you take nevirapine, 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?"and "Who should not take nevirapine ?"
•receive dialysis
•have skin problems, such as a rash 
•or your child has trouble swallowing pills
•have any other medical conditions
•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. You should not breastfeed if you have HIV because of the risk of passing HIV to your baby. Do not breast-feed during treatment with nevirapine. 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 may affect the way other medicines work, and other medicines may affect how nevirapine works.
You should not take nevirapine if you also take:
•St. John's Wort.  St. John's Wort can lower the amount of nevirapine in your body.
•efavirenz (Sustiva®, Atripla®) , etravirine (Intelence®), rilpivirine (Edurant® Complera®), or delavirdine (Rescriptor®).
•atazanavir (Reyataz®)
•lopinavir and ritonavir (Kaletra®) once daily
•fosamprenavir calcium (Lexiva®) without ritonavir (Norvir®)
•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.

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®)
•amiodarone, disopyramide (Norpace®), lidocaine
•carbamazepine, clonazepam (Klonopin®), ethosuximide (Zarontin®)
•diltiazem, nifedipine, verapamil
•cyclophosphamide
•ergotamine
•cyclosporine, tacrolimus, sirolimus (Rapamune®)
•cisapride (Propulsid®)
•fentanyl
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?

•Nevirapine is always taken in combination with other anti-HIV medications.
•Take nevirapine 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.
•If your child is prescribed nevirapine, your child's doctor will tell you exactly how nevirapine should be taken.
•You may take nevirapine with or without food.
•Do not miss a dose of nevirapine. If you miss a dose of nevirapine, 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 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 starting dose again, which is taken 1 time each day for 14 days.

Starting nevirapine 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 nevirapine 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.
•Do not increase your dose to 2 times a day if you have a rash.
•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.
2. Day 15, you will take 1 nevirapine tablet two times a day.

Starting nevirapine extended-release tablets when this is the first time you are taking any form of nevirapine:

Your doctor should start you with 1 dose of nevirapine tablets each day to lower your chance of getting a serious rash.
1. It is important that you only take 1 dose of nevirapine 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.
•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.
•Do not start nevirapine extended-release tablets if you have a rash.
2. Day 15, you take 1 nevirapine extended-release tablet 1 time a day as prescribed by your doctor.

Switching from nevirapine tablets to nevirapine extended-release tablets:

1. Take nevirapine extended-release tablet 1 time a day as prescribed by your doctor.
You may sometimes pass a soft mass in your stools (bowel movement) that looks like your nevirapine extended-release tablets. This will not affect the way your medicine works.

What are the possible side effects of nevirapine?

Nevirapine may cause serious side effects, including:
•See "What is the most important information I should know about nevirapine?"
°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 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.

How should I store nevirapine?

•Store nevirapine tablets at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.].
•Throw away nevirapine that is no longer needed or out-of-date.
Keep nevirapine and all medicines out of the reach of children.

General information about nevirapine

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

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

For more information, call ScieGen Pharmaceuticals, Inc., at 1-855-724-3436

What are the ingredients in nevirapine?

Active ingredient: nevirapine
Inactive ingredients:
Nevirapine Tablets: microcrystalline cellulose, lactose monohydrate, povidone, sodium starch glycolate, silicon dioxide and magnesium stearate.